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Early mobilisation after coronary angiography to reduce back pain
A thesis presented in partial fulfilment of the requirements for the degree of
Master of Nursing
at the
Eastern Institute of Technology
Taradale, New Zealand
Kelly Leigh Burn
2012
Copyright is owned by the Author of the thesis. Permission is given for a copy to be downloaded by an individual for the purpose of research and private study only. The thesis may not be reproduced elsewhere without the permission of the Author.
ii
ABSTRACT
Background:
Coronary heart disease accounts for over 25,000 inpatient admissions and nearly
4,000 day-case admissions in New Zealand per year (Hay, 2004). Cardiac
catheterization, via the femoral artery, is a common procedure undertaken to assess
for and treat coronary heart disease (Chair, Li and Wong, 2004; Chandrasekar et al.,
2001; Wang, Redeker, Moreyra & Diamond, 2001). After the procedure, the patient
remains on bed rest (mainly supine with the affected leg straight) for at least a further
4-6 hours (Sabo, Chlan and Savik, 2008) in order to reduce the chances of
complications at the groin site (Chair, Taylor-Piliae, Lam and Chan, 2003). Due to this
enforced supine bed rest, immobilization and restricted positioning, patients frequently
experience back pain (Chair et al., 2003). Prolonged bed rest causes pressure to be
exerted continuously onto the same back muscles, causing muscle fatigue and
weakness. This fatigue causes back pain due to back spasms (Chair et al., 2004).
Objectives:
The aim of this thesis was to, via a Systematic Review and Meta-Analysis, ascertain
whether it is safe for nurses to mobilise patients out of bed four hours or earlier after a
femoral approach coronary angiogram without the use of a vascular closure device, in
order to reduce back pain whilst not increasing the risk of vascular complications at the
puncture site.
Methodology:
The research question was answered by completing a Systematic Review and Meta-
Analysis, which included fifteen studies; eleven randomised, two quasi-randomised and
two non-randomised controlled trials. The studies were collated, evaluated and
summarised using the Cochrane Collaboration’s framework. Each individual study was
also graded for quality of the evidence by allocating a level to it using the Grades of
Recommendation, Assessment, Development and Evaluation (GRADE) Working
Groups grades of evidence (Schunemann et al., 2008).
Selection criteria:
All randomised controlled trials (RCT’s), quasi-randomised controlled and non-
randomised controlled trials found in the literature search, that compared the safety of
iii
early mobilisation with vascular complications after a femoral approach diagnostic
coronary angiogram, were considered for inclusion in the review. In all, 15 studies from
around the world, published since 1996, were chosen.
Data collection and analysis:
Once studies had been obtained, they were vetted against the inclusion and exclusion
criteria for this review. The article was thoroughly scrutinised and if it was suitable went
for data collection. Three assessors decided inclusion or exclusion of each study. This
reduced the chance of selection bias in the review. Risk ratios and 95% confidence
intervals were calculated for all studies. A Meta-Analysis was then undertaken
including all of the diagnostic coronary angiogram studies, with separate analysis of
just the randomised controlled trials.
Main results:
Six studies looked at mobilisation at ≤ 2 hours after a diagnostic angiogram. There was
no significant difference overall in incidence of vascular complications in these studies
(RR 1.1591; 95% CI 0.7544-1.7809; P 0.5023). Ten studies looked at the safety of
mobilisation at ≤ 3 hours with no statistical significance in overall vascular
complications (RR 0.8430; 95% CI 0.7041-1.0094; P 0.0625). All 15 studies mobilised
their participants at ≤ 4 hours, again with no statistical significance in complications
(RR 0.8696; 95% CI 0.7399-1.0219; P 0.0891).
Authors’ conclusions:
The results from this study show no statistically significant difference in vascular
complications between the control groups and the early mobilisation out of bed groups
at ≤2, 3 or 4 hours post femoral approach coronary angiogram. Therefore, mobilisation
after coronary angiogram may be as safe at 1 ½ to 4 hours mobilisation as it is at 6
hours and may have a positive benefit of reducing back pain related to lying in bed.
Keywords:
coronary; cardiac; angiogram; angiography; catheterisation; back pain; discomfort;
mobilisation; ambulation
iv
ACKNOWLEDGEMENTS
Writing this thesis has been a true test of my willpower and motivation. Completing it
has been my life’s biggest challenge and greatest reward. This process could not have
been completed without the assistance of many people, who have guided, supported
and encouraged me.
Firstly, I would like to thank my supervisors Bob Marshall and Gill Scrymgeour for their
ongoing advice and guidance throughout the writing of the thesis.
My special thanks to my partner David as, without your love, support and expert
computer skills, this thesis would have never been written. Your patience and
encouragement whilst I completed this project has been greatly appreciated. Thanks
also to my parents Neil and Jenny who have not only been immensely supportive
throughout my entire post-graduate studies, but also provided a haven away from
home to concentrate on my thesis writing and sustenance to keep me going. Thanks
also to my sister Toni for her encouraging texts and emails.
I would like to acknowledge my Charge Nurse Manager Vicki Krog, who not only
supported me throughout the past year, but also enabled plenty of study time to write
my thesis. Also thanks to Marie Habowska for her ongoing support and encouragement
and Breen Lewis, who proved to be an excellent sounding board.
This thesis is dedicated to my nieces Lara and Allie - may it inspire you to realise that
you too can achieve whatever you set your minds to.
v
TABLE OF CONTENTS
Abstract ii
Acknowledgements iv
Table of Contents v
Figures vi
Tables vii
Appendices viii
Glossary of Terms ix
Chapter 1 - Introduction 1
Background 1
Researchers Interest 3
Research Question 4
Aims of the Research 4
Significance of this Research 4
Thesis Overview 5
Chapter 2 – Literature Review 7
Patient Factors Affecting Back Pain 7
Position Changes Whilst on Bed Rest 11
Radial Artery Approach Coronary Angiogram 13
Use of a Femoral Artery Vascular Closure Device 21
Early Mobilisation 27
Chapter 3 - Methodology 30
Evidence Based Practice 30
Evidence Based Practice and Nursing 31
Systematic Reviews and Evidence Based Practice 31
Thesis Methodology 33
Chapter 4 - Systematic Review 40
Review Protocol 98
Chapter 5 - Discussion 104
Chapter 6 - Conclusions 112
References 115
vi
FIGURES
Figure I Appendix I. Flowchart for inclusion / exclusion of studies 94
vii
TABLES
Table 1 Summary of Findings 45 Table 2 Risk of Bias in Included Studies 55
Table 3 Summary of Interventions in Early Mobilisation Trials 61
Table 4 Characteristics of Included Studies 69
Table 5 Characteristics of Excluded Studies 85
Table 6 ≤ 2 hours bed rest - total bleeding complications 86
Table 7 ≤ 2 hours bed rest - total vascular complications 87
Table 8 ≤ 3 hours bed rest - total bleeding complications 88
Table 9 ≤ 3 hours bed rest - total vascular complications 89
Table 10 ≤ 4 hours bed rest - total bleeding complications 90
Table 11 ≤ 4 hours bed rest - total vascular complications 91
Table 12 Results Randomised Controlled Trials Only 92
Table 13 Results – All Included Studies 93
Table 14 Risk of Bias Assessment Tool 101
Table 15 Data Collection Tool 101
viii
APPENDICES
Appendix I Flowchart for inclusion / exclusion of studies 94
Appendix II Search Strategies 95
Appendix III Criteria and definitions for risk of bias assessment 96
Appendix IV Systematic Review Protocol 98
Appendix V Research Notification Form 126
Appendix VI Low Risk Research Questionnaire 127
ix
GLOSSARY OF TERMS
Term Definition
Femoral Angiography Visualising the arterial system by placing a catheter into the right or left femoral artery
(Best, Pike, Grainger, Eastwood & Carroll, 2010)
Radial Approach Visualising the arterial system by placing a catheter into the radial artery (Caputo et al.,
2011).
Coronary Angiogram Injection of a radiopaque contrast media into the coronary arteries under fluoroscopy,
allowing visualisation of the coronary anatomy and pathologies such as atherosclerosis,
thrombosis and patency of any coronary artery bypass grafts (Asinas, 2010)
Manual Pressure Placing pressure with the fingers or hand on the femoral artery to maintain haemostasis
(Oxford University Press, 2012)
Mechanical Pressure Placement of a Femostop™ (or equivalent) device over a punctured artery to apply
pressure and provide haemostasis (Hoglund, Stenestrand, Todt & Johansson, 2011)
Vascular Closure Device A device deployed at the puncture site of an artery to seal the perforation. They are either
intravascular or extravascular collagen plug devices, suture based closure devices, staples
or clips (Narasimhan & Gabriel, 2011).
Back Pain Self-perceived unpleasant feeling on the rear surface of the human body from the
shoulders to the hips (Hoglund et al., 2011; Oxford University Press, 2012)
Bleeding Active bleeding from the arterial puncture site (Mah, Smith & Jensen, 1999)
Haematoma Visible and/or palpable lump under the skin which contains subcutaneous blood from the
arterial puncture site (Hoglund et al., 2011)
Pseudoaneurysm A dissection of the layers of the arterial wall, into which arterial blood enters (McCance &
Huether, 2002)
Early Mobilisation Decreasing the time a patient spends on bed rest from the traditional time a specific unit
allows (Best et al., 2010)
Systematic Review A collation of “all empirical evidence that fits pre-specified eligibility criteria in order to
answer a specific research question” (Green et al., 2008, p. 6).
Meta-Analysis The combining of statistical results from more than one study on a similar research issue,
to produce a pooled effect size and therefore to evaluate the effectiveness of the study
interventions (Acton, 2001)
Bias “A systematic error, or deviation from the truth, in results or inferences” (Higgins and
Altman, 2008, p. 188).
Evidence-based Practice The conscientious use of current best evidence from relevant, valid research to guide
practice decisions in the delivery of health care (Fineout-Overholt, Melnyk & Schultz, 2005;
Joanna Briggs Institute, 2012)
Heterogeneity Variability between studies in participants, interventions, outcomes, methods or
interventional effects which can lead to bias in the true interventional effect (Deeks, Higgins
and Altman, 2008)
Homogeneity Studies with similar participants, interventions, outcomes, methods or interventional effects
which when compared give meaningful results (Deeks et al., 2008)
1
Chapter 1
INTRODUCTION
The purpose of this thesis is to examine what factors a nurse can put in place to either
minimize or prevent back pain in adults on bed rest following a coronary angiography
procedure. The Systematic Review and Meta-Analysis incorporated in this thesis
ascertains whether it is safe for nurses to mobilise patients out of bed four hours or
earlier after a femoral approach coronary angiogram without the use of a vascular
closure device, in order to reduce back pain whilst not increasing the risk of vascular
complications at the puncture site. The information gained and presented in the
research findings will help medical professionals, working in the area of coronary
angiography, to put into place measures that may help to improve their patients
comfort post-angiogram whilst also maintaining their safety.
This chapter contains an introduction to the thesis and Systematic Review including a
background to coronary angiography and back pain. It then presents the research
question and the aim and significance of the research. Lastly, it contains an overview
of the entire thesis by chapter.
Background
Coronary heart disease
Coronary heart disease remains the leading cause of death in New Zealand at 21%,
with rates of cardiovascular disease mortality in Maori people two and a half times the
rate of other New Zealanders (Ministry of Health, 2011). It accounts for over 25,000
inpatient admissions and nearly 4,000 day-case admissions in New Zealand per year
(Hay, 2004). Although rates of death related to ischaemic heart disease are reducing
every year in New Zealand, the rate of reduction has progressively slowed, most likely
related to the increase of obesity and type 2 diabetes (Tobias, Sexton, Mann & Sharpe,
2006).
History of coronary angiography
Coronary angiography is a common procedure undertaken to assess for and treat
coronary heart disease (Chair et al., 2004; Chandrasekar et al., 2001; Wang et al.,
2001). The first cardiac catheterization was performed on a human being in 1929,
when Werner Forsmann cannulated himself and visualised his right atrium under
2
fluoroscopy. Left ventricle heart catheterisation followed in 1950, closely followed by
coronary artery catheterisation by F. Mason Sones in 1959 via the brachial route
(Bogart, 1998) and Dr Melvin Judkins in 1967 via the femoral artery approach
(Lehmann and Hotaling, 2005). Numbers of coronary angiograms increase every year
(Galli and Palatnik, 2005) and have now become one of the most frequently carried out
invasive procedures within hospitals (Leung, Hallani, Lo, Hopkins and Juergens, 2007).
Coronary angiography
Coronary angiography involves injection of a radiopaque contrast media into the
coronary arteries under fluoroscopy, allowing visualisation of the coronary anatomy
and therefore pathologies such as atherosclerosis, thrombosis and patency of any
coronary artery bypass grafts (Asinas, 2010). Trans-femoral puncture via a 5F to 8F
sheath is the most common approach, but the brachial and radial arteries can also be
used (Chair, Thompson and Li, 2007). After a diagnostic angiogram, coronary
angioplasty and stenting may be required, which can immediately relieve symptoms
and reduce the chances of a recurrence of ischaemic events in the future (Gallagher,
Trotter and Donoghue, 2010). Most patients post-angiogram are discharged within 24
hours, with an increasing trend towards same day discharge (Lauck, Johnson &
Ratner, 2005).
Post-angiography care
They are many differences in practices for care post-angiogram (Wang et al., 2001).
Arterial femoral sheaths after a diagnostic coronary angiogram are generally removed
immediately post-procedure (Lauck et al., 2005). After sheath removal, haemostasis
(the time from sheath removal to cessation of bleeding) is usually maintained with
manual compression, either with digital pressure or an adjunctive mechanical
compression device. Arterial vascular closure devices may also be used at the access
site to gain haemostasis and allow early mobilisation (Prada-Delgado et al., 2011). The
patient then remains on bed rest (mainly supine with the affected leg straight) for a
further 4-6 hours following the diagnostic procedure (Sabo et al., 2008). This is to
reduce the chances of complications at the groin site (Chair et al., 2003). These
complications can include groin or retroperitoneal haematoma, arterial bleeding or
pseudoaneurysm and may happen in up to 9% of cases (Fowlow, Price and Fung,
1995). At times this bed rest can be imposed until the following morning (Chair et al.,
2004; Koch et al., 1997).
3
Back pain post-procedure
Due to this enforced supine bed rest, immobilization and restricted positioning, patients
frequently experience back pain (Chair et al., 2003). Prolonged bed rest causes
pressure to be exerted continuously onto the same back muscles, causing muscle
fatigue and weakness. This fatigue causes back pain due to back spasms (Chair et al.,
2004). Keeling, Fisher, Haugh, Powers and Turner (2000) found in their study looking
at early mobilisation that 92% of participants required some sort of analgesia for back
pain. Wood et al. (1997) reported 42% of the patients in their control arm complained of
back pain at 4 hours and 14% in the 2-hour mobilisation group. Augustin, de Quadros
and Sarmento-Leite (2010) stated 40.8% of the patients in their sample of 347 patients
experienced back pain. From these figures, it is evident back pain is a significant issue
faced by patients on bed rest after a coronary angiogram.
Rezaei-Adaryani, Ahmadi and Asghari-Jafarabadi (2009) have suggested that bed rest
and positioning regimes after coronary angiogram are based on tradition rather than
research. The aim of this thesis and included Systematic Review is to ascertain what
factors a nurse can put in place to either minimize or prevent this back pain, focusing
mainly on early mobilisation.
Researchers Interest
As the researcher on this project, I have worked in the field of nursing for 17 years and
in the area of interventional radiology for 2½ years. I have often observed over this
time that enforced immobilisation and bed rest for my patients post-angiography leads
to discomfort and back pain. This research is important to me, as I feel there must be a
better way of doing things to improve the comfort of my patients. A comprehensive
literature search has suggested that sitting up in bed and mobilizing earlier improved
back pain with little increase in vascular complications. I will assess the literature to
determine if it is possible to make recommendations that will reduce patient’s
discomfort and back pain levels, whilst enabling their safe treatment post-angiography.
Unit’s current practice
The unit I work in at present has a policy of four hours bed rest (two hours supine with
affected leg straight then two hours sitting up 45° - 90°) post-diagnostic angiogram.
This all follows at least one hour lying flat during the actual procedure. I have tried
many different ways to relieve the back pain such as a pillow under the knees or a
4
back roll but nothing seems to work for any great length of time. Once the patient starts
mobilising out of bed, however, the back pain seems to quickly resolve.
Research Question
Is it safe for nurses to mobilise patients out of bed four hours or earlier after a femoral
approach coronary angiogram without the use of a vascular closure device, in order
to reduce back pain whilst not increasing the risk of vascular complications at the
puncture site?
Aims of the Research
The aim of this research is to perform a literature review to ascertain what factors can
be put in place by nursing staff caring for patients after a femoral approach coronary
angiogram to reduce back pain. These factors must also take into account patient
safety; thereby not increase the patient’s risk of arterial bleeding or haematoma at the
puncture site. A Systematic Review and Meta-Analysis will then be undertaken to
answer the above research question. Significance of this Research
The purpose of the literature review was to explore the available research to ascertain
what factors reduced or prevented back pain in patients who have a femoral artery
approach coronary angiogram. From this, the factor that was most effective in reducing
back pain after an angiogram was earlier mobilisation out of bed. Randomised, non-
randomised and quasi-randomised controlled trials identified in the literature search
were collated, evaluated and summarised by undertaking a Systematic Review and
Meta-Analysis using the Cochrane Collaboration framework.
Only one Meta-Analysis was located in the search for Systematic Reviews or Meta-
Analysis studies on the topic of early mobilisation post coronary angiography. Chair,
Fernandez, Lui, Lopez and Thompson (2008) carried out a Systematic Review / Meta-
Analysis entitled “The clinical effectiveness of length of bed rest for patients recovering
from trans-femoral diagnostic cardiac catheterization” (p. 352). This study looked at 18
studies involving diagnostic cardiac angiography from the period 1985 – 2007. It
involved only randomised controlled trials.
This Systematic Review aims to build on the Systematic Review by Chair et al. (2008),
including studies published after 2007. It will also contain non-randomised and quasi-
5
randomised controlled trials. A Cochrane Collaboration Systematic Review on this topic
was unable to be located.
It is already clear from the studies in the literature review that early mobilisation assists
in the reduction of back pain, whilst not putting the patient at increased risk of vascular
complications. The Systematic Review and Meta-Analysis will collate all of the
information from each study and provide recommendations as to the early mobilisation
of patients after a femoral approach coronary angiogram. It will guide nurses and
medical staff in their care of patients, to either reduce or prevent this back pain using
the evidence-based recommendations for care that will come as a result of this review.
The followers of the recommendations will have confidence, knowing they are not only
based on just one research trial but an evaluation of many.
Thesis Overview
Chapter One: Introduction
The first chapter in the thesis includes an introduction to the thesis and Systematic
Review. It provides a background to coronary angiography and back pain and presents
the research question, the aim and significance of the research.
Chapter Two: Literature Review
The second chapter contains a thorough literature review of all methods of potentially
decreasing back pain after a femoral approach diagnostic coronary angiogram. They
are discussed by their main themes including patient factors that can affect back pain,
position changes whilst on bed rest, using a radial artery approach instead of femoral,
using a femoral artery vascular closure device and early mobilisation after the coronary
angiogram. A discussion is then presented as to why early mobilisation was chosen
from these factors as the topic of the Systematic Review and Meta-Analysis.
Chapter Three: Methodology
This chapter looks at the methodology of the Systematic Review and Meta-Analysis. It
starts by introducing evidence-based practice, how evidence-based practice is
important to nursing practice and how the Systematic Review and Meta-Analysis is the
top level of evidence from which to base practice on. Next the research question is
presented, along with the methodology of this thesis – Systematic Review and Meta-
Analysis. The Cochrane Collaboration Systematic Review framework is presented
6
along with the ethical considerations required when completing a Systematic Review
as part of a nursing thesis.
Chapter Four: Systematic Review
The full Systematic Review is presented in this chapter. It follows the Cochrane
Collaboration framework and is presented as if it were a separate piece of work for
publication on the Cochrane Collaboration database. The Systematic Review Protocol,
which is the initial research proposal that would be sent to the Cochrane Collaboration,
sits in the Systematic Review as Appendix 4.
Chapter Five: Discussion
This discussion chapter ties together both the nursing thesis and the Systematic
Review. It discusses the main findings of the Systematic Review, that mobilisation after
coronary angiogram may be as safe at 1 ½ to 4 hours mobilisation as it is at 6 hours
and may have a positive benefit of reducing back pain related to lying in bed. The
chapter compares these results with the Systematic Review of Chair et al. (2008) and
the findings of other studies published on the topic.
Chapter Six: Conclusion
The final chapter provides a conclusion to the thesis and discusses how the findings of
this research could be included into the evidence-based practice of nurses and other
health professionals. It also presents suggestions for further research.
7
Chapter 2
LITERATURE REVIEW
Introduction
The previous chapter contained an introduction to the thesis and Systematic Review
including a background to coronary angiography and back pain. The research question
and the aim and significance of the research were presented, as was an overview of
the entire thesis by chapter.
Prior to carrying out the Systematic Review and Meta-Analysis, a literature search was
undertaken to research all methods of potentially decreasing back pain after a femoral
approach diagnostic coronary angiogram. This chapter presents the studies reviewed
in the literature search, discussed by their main themes including patient factors that
can affect back pain, position changes whilst on bed rest, using a radial artery
approach instead of femoral, using a femoral artery vascular closure device and early
mobilisation after the coronary angiogram.
Search Strategy
To locate studies that would provide information for the literature review, a computer
search of the databases MEDLINE, Wiley InterScience, CINAHL, PubMed, Proquest
Central, Google Scholar, Science Direct and Cochrane Database of Systematic
Reviews was carried out. Reference lists of already acquired research were also
searched. Search terms used for initially searching the databases were (coronary OR
cardiac) AND (angio* OR catheteri*) AND (radial OR femoral) AND (back pain OR
position* OR mobili*ation OR discomfort OR ambulation) OR (vascular AND closure).
Patient factors that affect back pain
It has been well documented that bed rest after coronary angiogram causes back pain
and is one of the most common complaints of patients (Hoglund et al., 2011; Koreny,
Riedmuller, Nikfardjam, Siostrzonek & Mullner, 2004; Lepper, 2004; Pollard et al.,
2003; Pornratanarangsi et al., 2010; Vlasic, 2004; Vaught & Ostrow, 2001). In a
qualitative study on patients’ responses to the angioplasty experience, patients
validated this by voicing their experiences of back pain, for example: “my back was
about ready to break” and “all I could do was cry… I wasn’t worried about my heart, just
my back” (Gulanick, Bliley, Perino & Keough, 1997, p. 28). However, not everyone gets
8
back pain and some experience more than others. If a person caring for a patient post-
angiogram is aware of the factors that could lead to an increase in back pain in
particular patients, they may be able to put interventions in place to prevent pain.
Age
Of the studies found in the literature search, one looked solely at patient factors that
may affect back pain levels when a patient is on bed rest after coronary angiogram.
Chair et al. (2004) carried out this prospective study alongside another randomised
controlled trial. It involved looking at the demographic information of 419 patients who
have undergone an angiogram and required a period of 8 – 24 hours bed rest. This
study found that younger patients experienced significantly more back pain than older
people.
Hoglund et al. (2011) found different results from Chair et al. (2004) in their study of the
early mobilisation (1.5 hours vs. 5 hours) of 104 participants and the effect of two
different timing methods on back pain levels. They found that patients over 70 years
tended to experience more back pain whilst on bed rest but this was not significant.
However, four hours after they began mobilising, when over 70 years of age, the
patients experienced back pain levels that were significantly higher statistically
(p<0.05) than the younger participants.
The age range was relatively similar between these two studies, with Chair et al. (2004)
having a mean age of 61.6 years and Hoglund et al. (2011) slightly higher at 63.7
years. The differences that were more obvious between these studies were the timing
differences of the back pain measurements and the length of time the participants
remained in bed. Hoglund et al. (2011) measured back pain at eight different time
points from immediately after coronary angiogram until a telephone interview 48 – 72
hours post discharge. Chair et al. (2004) measured back pain at six hours whilst the
participants were all still on bed rest and then the next morning when they were
mobilising out of bed. Chair et al. (2004) showed that in longer periods of bed rest (8 –
24 hours), younger people experienced higher levels of back pain and conversely, in
Hoglund et al. (2011), with shorter times to mobilisation (1.5 – 5 hours) older people
tend to experience a higher level of back pain, with this pain continuing even after a
period of mobilisation.
9
Another reason that older people could experience higher levels of back pain is that
they are more at risk of vascular complications after a femoral artery puncture
(Dumont, Keeling, Bourguignon, Sarembock & Turner, 2006; Waksman et al., 1995).
When a patient experiences a vascular complication, they are required to spend an
increased length of time on bed rest until haemostasis is reached. This can lead to an
increased risk of developing back pain (McCabe, McPherson, Lohse & Weaver, 2001).
Patient’s history of back pain
Chair et al. (2004) found that a history of back pain was not significantly related to back
pain in the six hours around bed rest and mobilisation following coronary angiography.
However, complaints of back pain the following morning from patients who had been
on bed rest for between eight and 24 hours overnight and had a history of back pain,
were significantly higher than those who did not have a history of back pain but had
experienced back pain whilst on bed rest. From the results of this study, it could be
concluded that a patient with a history of back pain should be mobilised as soon as
possible to reduce the risk of increasing back pain, whilst maintaining patient safety
from vascular complications.
Body mass index (BMI)
Hoglund et al. (2011) found that the lower the patient’s BMI, the more back pain
experienced. However, Chair et al. (2004) disagreed, finding an increased BMI
significantly increased back pain that they put down to the fact that persons who are
overweight generate a proportionally greater amount of force on their back muscles. As
stated earlier, the difference in these two studies is the length of time in bed. From the
results of Chair et al. (2004) a conclusion could drawn that the longer the bed rest time
and the higher the BMI, the more back pain may be experienced. In the shorter times
to mobilisation, back pain may be experienced more in the patients with a lower BMI
(Hoglund et al., 2011).
A person with an increased BMI has an increased chance of a vascular complication
after a femoral approach coronary angiogram (Gall, Tarique, Natarajan & Zaman,
2006; Waksman et al., 1995) potentially leading to a longer time on bed rest and
increased chance of back pain (Chair et al., 2004). Gall et al. (2006) reason that this
may be due to the difficulty in applying pressure on the insertion site in the femoral
artery post sheath removal due to the deeper location of the femoral artery pulse. Cox
et al. (2004) states that gaining femoral artery access itself is very difficult on patients
10
with an increased BMI, with potential for more than one arterial puncture leading to
difficulty in gaining haemostasis and an increased risk of vascular complication.
Gender
Fowlow et al. (1995) found that in their study of ambulation after a femoral approach
angiogram, that female patients experienced significantly higher back pain levels than
their male counterparts when mobilised at six to eight hours. Chair et al. (2004) found
no difference in the back pain levels between genders when mobilised between 8 and
24 hours.
In several studies it has also been found that females are more at risk of developing
vascular complications such as bleeding and haematoma than males (Dumont et al.,
2006; Eggebrecht et al., 2002; Gall et al., 2006; Gillane & Pollard, 2009; Mah et al.,
1999; Waksman et al., 1995) potentially leading to a longer bed rest requirement.
Hoglund et al. (2011) reason that this could be due to the smaller vasculature of
females, which can lead to multiple punctures of the artery and an increased chance of
a vascular complication.
Summary
Chair et al. (2004) suggests nurses have a key role in promoting patient comfort and,
when caring for patients post coronary angiogram, should take into account that some
patients may require more pain relief, position changes or back rubs than other people.
If health professionals caring for patients after femoral approach coronary angiogram
are aware of which patients have the potential to experience a higher level of back pain
then this can occur.
Actual information on patient factors that increase an individual’s chance of developing
back pain after coronary angiogram is somewhat limited. In this literature search, few
studies were found where specific information about patient characteristics and back
pain after coronary angiogram were collected and presented. From the literature, it was
ascertained that people caring for patients after femoral approach angiogram should
take into account that females may experience more back pain and younger people
and people with a low BMI on a shorter period of bed rest may experience a higher
level of back pain. Conversely, in units where patients remain on bed rest for an
extended period of time, older people, people with a history of back pain and patients
with an increased BMI may experience a higher level of back pain. People at higher
risk of vascular complications (older persons, people with an increased BMI and
11
females) are also at risk of higher levels of back pain due to a potentially increased
length of bed rest.
Most back pain resolves quickly on mobilisation and so the quicker the patient can be
mobilized, whilst maintaining their safety from vascular complications, the better for the
reduction of back pain (Chair et al., 2004). This can be seen in the Systematic Review
in Chapter 4.
Position changes whilst on bed rest
Changing a patient’s position in bed whilst on bed rest after a femoral approach
diagnostic coronary angiogram, whether it is rolling from side to side or back of bed
elevation to reduce or prevent back pain, is a well-researched procedure. This literature
review found five randomised controlled trials that solely looked at position changes
whilst on bed rest, without focusing on earlier mobilisation as well. Studies that also
involved early mobilisation after a femoral approach diagnostic coronary angiogram will
be presented later in the Systematic Review in Chapter 4.
Changing patients position
The study carried out by Yilmaz, Gurgun and Dramali (2006) involved a very complex
methodology. It included five different study groups with complex instructions on back
of bed elevation and alternating side to back lying after immediate sheath removal. The
control group maintained supine bed rest on their back until the next morning. Two
experimental groups had the head of the bed elevated to 30-45° (after one hour)
alternating side to back lying for 8 hours bed rest (with differing sandbag weights and
durations in each group). The other two groups remained on supine bed rest with
differing sandbag weights. Results of this study showed a significant decrease in back
pain in the two groups who were allowed to sit up and roll side to side compared to the
three groups who were not allowed to change position (p<0.001). However, the groups
on supine bed rest who had sandbags in place experienced significantly more back
pain and had no decrease in vascular complications when compared to the control
group without sand bags. Therefore, Yilmaz et al. (2006) suggests that sandbags do
not reduce vascular complications, can lead to increased back pain and therefore
should not be used.
12
Back pain was statistically significantly reduced (p<0.001) in favour of the experimental
over the control group in the study by May, Schlosser & Skytte (2008). In this study, the
femoral sheath was removed immediately, a sandbag was placed over the puncture
site, head of bed raised to 30°, with the experimental group allowed to move as freely
as the sandbag permitted. There was no significant difference in numbers of patients
experiencing bleeding or haematoma in the experimental vs. control group.
The participants in the experimental group of Chair et al. (2003) had their position
varied from supine, right side-lying and left side-lying hourly from two hours after
immediate sheath removal, whilst the control group were maintained supine on their
back for the same length of time (8 - 24 hours depending on the cardiologist). Back
pain measures at two, four and six hours and the next morning were significantly
reduced in the experimental group when compared to the control group (<0.001 at all
timeframes at and after two hours). There were no statistical differences between the
two groups in vascular complications (p=0.372).
Rezaei-Adaryani, Ahmadi, Mohamadi and Asghari-Jafarabadi (2009) ran a trial in Iran
where, in the two experimental groups, they elevated the back of the bed incrementally
by 15° every hour after immediate sheath removal until 45° was reached and then side
lying with 15° head elevation once the fifth hour was reached, with total bed rest for
eight hours. One of the experimental groups also had a thin pillow under one side,
which was changed from one side to the other every half an hour. The control group
remained supine on their back, with a sandbag in place at the femoral access point, for
eight hours. Back pain levels were significantly reduced in the experimental groups vs.
the control group after the third hour (p<0.05), without increase in vascular
complications (p=0.6 for bleeding, p=0.99 for haematoma).
The participants in the study by Pooler-Lunse, Barkman and Bock (1996) had the head
of their bed elevated to 45° once haemostasis was maintained after immediate sheath
removal. After 15 minutes at this level, the patient could raise the back of the bed
between flat and 45° as they wished. Results from this study showed a statistically
significant reduction in pain for the experimental group (p<0.02 overall, p<0.05 at three
and seven hours) over the control group who were supine for six hours and not mobile
around the bed. There were no differences between the groups in regards to vascular
complications.
13
Summary
All five studies, despite their varying methodologies, determined there was no
significant differences in bleeding rates or haematoma formation in those patients
allowed to change position in bed when compared to the patients in the control groups
who remained supine without moving privileges. It was also clearly shown in all of the
studies that there is a significant reduction in back pain when patients were allowed to
move in the bed as opposed to lying supine with no movement. This leads to the
conclusion that position change in bed, whether it is from side to side or back of bed
elevation, has a significant effect on reducing back pain after coronary angiogram with
no significant increase in vascular complications.
However, all of the studies still showed, that despite position changes within the bed,
patients in the experimental groups still had the potential to experience back pain.
There was no decrease in time to mobilisation in any of the studies meaning patients
remained dependent on nurses, required assistance with activities of daily living and
used more nursing resources (Chair et al., 2007; Wang et al., 2001). The repositioning
regimes in three of the studies were complicated and required planning and time to
remember where and when the patient should be repositioned.
It can therefore be concluded that repositioning patients in bed (using as simple a
regime as possible) may be a safe way to reduce back pain after coronary angiogram.
However, elements in the review suggest more can be done for these patients to
reduce back pain, in the form of earlier mobilisation, and this will be presented in the
Systematic Review in Chapter 4.
Radial artery approach coronary angiogram
Although the femoral artery remains the standard approach for coronary angiograms,
the radial artery approach is gaining recognition as an alternative access route (Sallam,
Al-Hadi, Rathinasekar & Chandy, 2009). When looking at preventing and reducing
back pain after a coronary angiogram, using the radial artery as the access route
makes sense. After a trans-radial approach coronary angiogram procedure, patients
may mobilise immediately potentially leading to an increased patient comfort and
satisfaction (Egred, 2011; Sallam et al., 2009) and possible earlier discharge (Agostoni
et al., 2004; Rosenstein et al., 2004). However, not every patient is suitable for a trans-
radial approach and not every operator is trained in this method or has the required
equipment available to use (Caputo et al., 2011).
14
History
The first radial artery access for a diagnostic coronary angiogram occurred in 1989,
when Lucien Campeau carried out the first radial approach coronary angiogram
followed closely in 1992 by Ferdinand Kiemeneij, who completed the first radial
approach PTCA (Agostoni et al., 2004; Caputo et al., 2011). Since then the trans-radial
approach has become more and more common due to its relatively low vascular
complication risk and potential for much earlier ambulation (From, Bell, Rihal & Gulati,
2011; Harrison & Grines, 2011). In some countries, radial access is now the dominant
access site replacing femoral access. Norway, Malaysia and Bulgaria have the highest
rates of radial access at 70-80%, with a worldwide average estimated at 20% (Caputo
et al., 2011; Harrison & Grines, 2011).
Benefits of radial artery access
The radial artery is considered to have several advantages over the femoral artery
approach (Agostoni et al., 2004; Sallam et al., 2009; Sciahbasi et al., 2011). These
include decreased vascular complications, no requirement to visualize the groin, ability
to avoid vessels damaged by peripheral vascular disease and easier access to the
artery, especially in patients with an increased BMI.
Decreased vascular complications
Vascular complication rates are much lower with trans-radial access when compared to
femoral artery access (Sallam et al., 2009; Egred, 2011). The radial artery is an easily
compressed artery, meaning that on removal of the arterial sheath, pressure can easily
be applied to the insertion point, leading to less chance of bleeding and vascular
complications (Agostoni et al., 2004; Sallam et al., 2009; Sciahbasi et al., 2011). A
study by Sallam et al. (2009) showed a vascular complication rate of 8.2% in their
femoral access group with 116 participants compared to no vascular complications in
their radial access group with 105 participants. Fewer vascular complications lead to a
decreased length of admission, with reduced hospital costs and improved clinical
outcomes (Caputo et al., 2011). The radial artery is away from other major blood
vessels and nerves and has alternative blood flow through the ulnar artery to the hand
in most cases (Caputo et al., 2011; Cevik, Cemil & Nugent, 2010; Rathore & Morris,
2008).
15
Age
As stated earlier, older people are more at risk of vascular complications after a
femoral artery puncture (Dumont et al., 2006; Waksman et al., 1995). In their study
looking at radial vs. femoral approach angiogram in 288 octogenarians, Louvard et al.
(2003) found a significant decrease in vascular complications with the radial approach
in this older population compared to femoral access. However, patients over 75 years
of age do have an increased radial access failure rate due to advanced vascular
disease, tortuosity of the subclavian artery and aorta, with potential calcification and
diffuse atherosclerosis, making catheter manipulation very difficult (Dehghani et al.,
2009).
Females
In their study on trans-radial vs. femoral artery approach coronary angiogram, Sallam
et al. (2009) found that in their predominantly Muslim population, the females much
preferred the trans-radial route, especially when menstruating, with many very reluctant
to go ahead via the trans-femoral route.
Peripheral vascular disease
Access via the femoral artery can be difficult in patients who have peripheral vascular
disease, especially in the increasingly more common aging population. Trans-radial
access reduces the chances of a vascular complication in patients with peripheral
vascular disease (Egred, 2011).
Increased BMI
As stated earlier, increased BMI has been reported to increase the chances of a
vascular complication in patients (Gall et al., 2006; Waksman et al., 1995). This may be
due to difficulty in applying pressure on the insertion site post sheath removal due to
the deeper location of the femoral artery pulse (Gall et al., 2006). In all patients,
including those with an increased BMI, the radial artery is superficial. Therefore it may
be easier to gain access via the radial route rather than femoral route in patients with
an increased BMI and also easier at the end of the procedure to gain haemostasis
(Cevik et al., 2010).
16
Limitations of radial artery access
Although the trans-radial approach is considered to have several major advantages
over the femoral artery approach (Agostoni et al., 2004; Sallam et al., 2009; Sciahbasi
et al., 2011), it also has limitations. These include a steep operator learning curve,
difficulty with radial artery anatomy, radial access complications, patients with coronary
bypass grafts and the potential requirement of an intra-aortic balloon pump, and
increased procedure length, radiation exposure and contrast usage.
Operator learning curve
Farman et al. (2011) discuss how, while the trans-radial approach for coronary
angiograms is being used more commonly around the world due to the benefits to the
patient, its acceptance amongst interventional cardiologists has been slow. The trans-
radial approach is more demanding than the trans-femoral approach and requires a
longer learning curve for the operator to gain the skills required. Accessing the radial
artery takes more time due to the technically more challenging approach (Rosenstein
et al., 2004; Sallam et al., 2009).
In the United States of America, the frequency of the trans-radial approach remains at
only 1.7% in the 2008 / 2009 year (Caputo et al., 2011), due to reasons such as a lack
of training, the steep learning curve required and the operator’s preference for the
femoral route. This also means fewer operators are able to teach the trans-radial
method (Harrison & Grines, 2011). Caputo et al. (2011) states trans-radial training
should ideally begin at the same time as the trans-femoral approach training begins so
that the interventional cardiology Fellow qualifies equally trained in both. They agree
with Harrison and Grines (2011) in that there are not enough interventional
cardiologists who are suitably qualified and skilled in radial approach angiograms to
train these Fellows.
Radial anatomy
Saito, Ikei, Hosokawa and Tanaka (1999) found in their study looking at radial artery
internal diameters vs. radial artery sheath outer diameters, that the inner diameter of
the radial artery was smaller than a 6F sheath in 14.3% of males and 27.4% of
females. Overstretching of the radial artery with the use of a ≥ 6F sheath in these
patients can lead to radial artery occlusion and artery spasm (Kanei et al., 2011).
17
In some procedures, a 7F sheath or greater may be necessary (Saito et al., 1999).
Sheath-less coronary catheters are now available, which can be used up to 8.5F (with
an outer diameter similar to a 6F sheath) in the radial artery without the requirement of
a sheath. However, these are not yet accessible in many countries including the United
States of America (Harrison & Grines, 2011).
Caputo et al. (2011) discusses how anatomical differences in some patients mean they
do not have dual circulation to the hand via a radial and ulnar artery. They state that a
negative (abnormal) Allen’s test is a contra-indication for trans-radial approach due to
the lack of arterial flow to the hand once a sheath and catheter are in the radial artery.
The Allen’s test is used to confirm anatomical suitability for a trans-radial approach.
Another test that can be used is placement of a pulse oximeter on the index finger, with
occlusion of the radial artery. A waveform suggests the patient has hand circulation via
the ulnar artery (Paul & Feeney, 2003).
In their Meta-Analysis of 12 radial vs. femoral coronary angiogram studies, Agostoni et
al. (2004) noted that all studies used the exclusion criteria of negative Allen’s test for
trans-radial approach and therefore these patients received a trans-femoral approach
angiogram. Gillane and Pollard (2009) state that between 10% and 27% of patients
may exhibit a negative Allen’s test making them ineligible for a trans-radial approach.
However, the validity of the Allen’s test prior to using radial access, and whether a
negative Allen’s test should lead to a radial approach not being used, is now being
questioned. Gilchrist (2006) and Hildick–Smith (2006) both believe that a negative
Allen’s test should not mean the radial artery is not used. Hildick-Smith (2006) explains
that many thousands of people, who have had a radial approach angiogram over the
15 years prior, would have shown false positive Allen’s tests due to incomplete
occlusion of the radial artery. Therefore, he concludes that with a 5% radial artery
occlusion expected on patients who receive a radial access coronary angiogram, there
should be a lot more examples of ischaemic hands, of which there are not. Hildick-
Smith (2006) and Gilchrist (2006) conclude that there is no evidence that a normal
Allen’s test is required for the safe undertaking of a radial access coronary angiogram.
Radial access complications
Radial artery perforation is a rare but potential risk for radial approach angiograms. It
can lead to compartment syndrome and acute hand ischaemia and has been reported
to occur in up to 1% of patients with radial access. Immediate recognition of this
18
problem and prompt action are required to limit damage to the limb (Kanei et al., 2011;
Sallam, Mehar and Al-Sekaiti, 2011).
In their study of radial vs. femoral approach coronary angiography, Sallam et al. (2009)
had a procedure failure rate of 17.1% in the radial access group due to complications
such as inability to gain access, radial artery spasm and subclavian artery tortuosity.
Caputo et al. (2011) believes that procedure failure via the radial approach should
decrease to less than 5% with a very skilled operator. From the findings of their study,
Lehmann et al. (2011) agree that experienced operators who perform more than 90%
of their angiograms via the trans-radial route have a failure rate of less than 5%.
Egred (2011) discusses how limitations and vascular access failure in the radial artery
approach can be due to anatomical variations such as tortuous arteries or stenosis, or
from persistent radial artery spasm. Kanei et al. (2011) state that 5 - 10% of cases can
experience radial artery spasm, mainly due to smaller arteries (especially in females),
multiple catheter changes and operator inexperience.
Agostoni et al. (2004) also discuss how the failure of procedures via a trans-radial
route can be due to the difficulties operators face cannulating the coronary ostia (where
the artery originates off the aorta) because it is more difficult to control and manipulate
the catheter via the radial access route. They give figures of a failure rate of the trans-
radial approach requiring crossover to a femoral approach as 1 in 14 patients and state
that all patients, despite the intended radial access route, should have a femoral
approach prepared just in case.
Patients with coronary artery bypass grafts
Visualisation of coronary artery bypass grafts is challenging from both the femoral and
radial route, due to where the coronary graft originates off the aorta and the lack of
catheter support from the aortic wall and aortic sinuses (Farooq, Mamas, Fath-
Ordoubadi & Fraser, 2011). Visualising coronary artery bypass grafts via the trans-
radial approach requires a very skilled operator, due to the increased difficulty in
gaining adequate support with the catheter via the radial artery. If an internal mammary
artery graft requires visualization, then a left sided trans-radial approach is required
(Caputo et al., 2011). The failure rate of the trans-radial approach attempting to
visualize coronary artery bypass grafts is seven times higher than with a femoral
19
approach attempting to do the same, due the technical difficulty of cannulating the
grafts (Farooq et al., 2011).
Requirement of an intra-aortic balloon pump
The trans-radial artery approach for coronary angiogram or PTCA does not allow for
the use of devices such as an intra-aortic balloon pump (IABP) (Agostoni et al., 2004;
Sallam et al., 2009). The IABP contains a balloon that is positioned in the aorta and
inflates on diastole. This increases the aortic diastolic pressure from the top of the
balloon back to the aortic valve during the diastolic period, which in turn increases
perfusion to the coronary arteries and improves myocardial oxygen delivery. On
deflation of the balloon during systole, the aortic pressure decreases and decreased
afterload occurs. With this comes decreased left ventricular workload and decreased
myocardial oxygen demands (Goldich, 2011).
Levy and Moussa (2011) and Gogo (2006) discuss how the IABP may be required in a
patient with cardiogenic shock to help maintain cardiovascular stability. It requires the
femoral artery route for insertion and a 7.5F sheath. Therefore, if a patient presents
with myocardial infarction, requiring a coronary angiogram, the risk of developing
cardiogenic shock before, during or after the procedure must be taken into account
when choosing femoral or radial access. If the patient requires an IABP, choosing the
femoral approach means access has already been gained for insertion of the pump if
required.
Increased procedure length, radiation exposure and contrast usage
Radial access for coronary angiogram often leads to an increased procedure time. This
has the potential to lead to increased radiation exposure and increased contrast dye
usage. In their study of radial vs. femoral access, Sallam et al. (2009) found that the
procedure time in the radial group was significantly longer than the femoral group (23.7
vs. 20.1 minutes). The measured radiation dose was also higher in the radial group,
because of this increased time, but not significantly so in this case. They suggested the
extra time was when gaining access, when fluoroscopy is not required. However,
Farman et al. (2011) found, looking at fluoroscopy times between radial and femoral
approach and between skill levels of operators, that the radial approach required
significantly more fluoroscopy time than the femoral. This was even more pronounced
with less skilled operators. This increased time may lead to an increased radiation
exposure, not only to the patient, but also to the operator.
20
Radiation exposure to the operator is also higher in the trans-radial approach due to
their closer proximity to the image intensifier. Therefore positioning of the arm
alongside the body and careful lead screen placement are vital to ensure the operator
is exposed to a smaller amount of radiation (Caputo et al., 2011). In their study
comparing operator radiation exposure in both radial and femoral access coronary
angiograms, Brasselet et al. (2008) found a significantly higher radiation exposure to
operators in the radial access group. They suggest weighing up the risk to the operator
with benefits to the patient when deciding which route to use, especially when a long
fluoroscopy time is expected, and always using lead screens and personal radiation
protective equipment.
An increased procedure length can also be significant in the patient experiencing a
myocardial infarction, where time is of the essence (Chodor et al., 2011). In their study
of radial artery access vs. femoral artery access in patients experiencing acute
myocardial infarction, Chodor et al. (2011) noted a significantly longer time from
hospital arrival to balloon inflation in the radial access group when compared to the
femoral access group. Overall times weren’t significantly different, which agreed with
the study by Sallam et al. (2009), where the delay was in sheath placement.
Summary
The radial access route has many advantages including its lack of vascular
complications (especially in patients with risk factors for bleeding post-procedure or
who are receiving anti-platelet medication or thrombolysis) and increased patient
comfort afterwards with the ability to mobilise straight away. However, the literature
suggests not every operator has the skills and expertise to carry out a coronary
angiogram via the radial artery. Some procedures such as visualising coronary artery
bypass grafts are difficult for even the most experienced operator when using trans-
radial access.
Not all patients are suitable for radial access. This may include patients with a negative
Allen’s test (although that concern is now disputed), physical deformities of the arms,
small arteries, those who present with actual or potential cardiogenic shock and may
require an IABP and those with a potentially long procedure ahead that may lead to a
high level of radiation exposure due to time (Brasselet et al., 2008). The longer time to
gain radial access may delay treatment in patients who present with myocardial
21
infarction, especially if access is unsuccessful and a switch to the femoral route is
necessary (Chodor et al., 2011).
The radial access route, although proven much safer, is still not without complications.
Up to 7% of radial access angiograms convert to a femoral artery approach due to
complications or difficulties (Agostoni et al., 2004), although this can drop to 5% with a
very experienced operator. Not all equipment to carry out a safe and effective
procedure via the radial route is available in every country (Harrison & Grines, 2011).
In summary, it would be of potential benefit to the patient if all coronary angiograms
could be carried out via the radial route, especially when trying to prevent or reduce
back pain post procedure. However, in up to 80% of cases worldwide (Caputo et al.,
2011), this is not done for many reasons as presented here.
Use of a femoral artery vascular closure device
Femoral artery vascular closure devices provide an alternative to manual or
mechanical methods of gaining haemostasis after a coronary angiogram (Nikolsky et
al., 2004). They were designed to avoid the need for manual compression and to
shorten bed rest times, therefore improving patient comfort and reducing back pain
(Adusumilli, Mah & Richardson, 2011; Biancari et al., 2010; Koreny et al., 2004).
Vascular closure devices were first developed in the mid-1990s, to overcome femoral
artery bleeding issues post-angiogram and angioplasty with the aim of decreasing the
rate of vascular complications (Dauerman, Applegate & Cohen, 2007; Sciahbasi et al.,
2009; Shroff, 2011). However, the rates of use have not increased as much as other
technologies such as drug-eluting stents (Dauerman et al., 2007).
There are several different types of vascular closure devices available, which can be
categorised as either intravascular or extravascular. The devices can be further
categorised into collagen plug devices, suture based closure devices and staples and
clips (Narasimhan & Gabriel, 2011).
Benefits of femoral artery vascular closure devices
There are several benefits to using vascular closure devices. These include earlier
haemostasis and earlier mobilisation, which can lead to reduced discomfort and back
pain. Vascular closure devices may also reduce vascular complications at the puncture
22
site, however there is some debate about this. Vascular complications with the use of
vascular closure device are discussed later in this section.
Earlier haemostasis
When a vascular closure device is used, the sheath is removed and the artery puncture
site immediately closed post-procedure, despite the patients’ coagulation status
(Chhatriwalla & Bhatt, 2006; Dauerman et al., 2007; Galli & Palatnik, 2005). Hamon
and Nolan (2008) state immediate removal of the sheath and use of vascular closure
devices after femoral artery access is beneficial in patients who have received
glycoprotein IIb/IIIa inhibitors and other medications that alter coagulation, without
having to wait for normalization of coagulation status.
Vascular closure devices reduce the time to haemostasis compared with manual
compression. Haemostasis should be immediate with placement of a vascular closure
device, whereas the time to haemostasis using manual or mechanical compression can
be 15 - 30 minutes after sheath removal (Dauerman et al., 2007). This also frees up a
nurse or doctor who would no longer have to apply manual compression.
Earlier mobilisation and reduced back pain
Possibly the most important benefit to the patient, after deployment of a vascular
closure device, is that they can ambulate much earlier than without the device
(Chhatriwalla & Bhatt, 2006; Galli & Palatnik, 2005). Caputo et al. (2011) and
Narasimhan and Gabriel (2011) explain how vascular closure devices have lead to
earlier ambulation and therefore improved patient comfort.
This literature search found three different studies where patients mobilised earlier after
coronary angiogram when a vascular closure device was deployed. In Sciahbasi et al.
(2009), patients in the manual compression group stayed on bed rest overnight, while
the group with vascular closure devices mobilised after three hours. Their study
involved 1492 participants who received a coronary angiogram. They compared radial
access, a femoral approach with use of vascular closure device and a femoral
approach with manual compression. When the discomfort of bed rest was measured
the day after their procedure, 55.8% of patients rated that their discomfort had been
above 5 / 10 in the manual compression group, whereas the group with vascular
closure devices rated their discomfort above 5 / 10 in 3.1% of cases for Starclose™
and 4.4% in AngioSeal™ cases. By mobilising the patients much earlier, because of
23
the vascular closure device, the patients discomfort levels were significantly decreased
(p<0.0001).
Hvelplund et al. (2011) carried out a study on 300 participants, after placement of an
AngioSeal™ device, where 144 mobilised immediately after either a coronary
angiogram (in fact walked out of the procedure room) and 156 mobilised at four hours
after bed rest with a compression bandage in place. Overall complications between the
groups were non-significant with control group 3.8% major complications versus 3.5%
in the immediate ambulation group, and 12.2% vs. 15.3% for minor complications
respectively. The authors conclude immediate ambulation after coronary angiograms is
safe with an AngioSeal™ device, and with routine use approximately 87% of patients
would be suitable for immediate ambulation.
Limitations of femoral artery vascular closure device
There are several limitations with the use of vascular closure devices. These include
contra-indications, device limitations, cost, a steep operator learning curve and
potential vascular complications with their use.
Contra-indications and device limitations
Contra-indications for the use of vascular closure devices include multiple arterial
punctures attempting to gain access (as the device will only close one of the
punctures), a femoral artery with a small diameter, femoral artery disease and sheath
insertion below the femoral artery bifurcation. Sheath insertion below the bifurcation
can occur in up to 13% of patients ruling them unsuitable for vascular closure device
placement (Dauerman et al., 2007). Applegate et al. (2010), Dehghani et al. (2010) and
Sciahbasi et al. (2009) state that in order to deploy a vascular closure device, a femoral
puncture must be more than 5mm above the femoral artery bifurcation, that the femoral
artery diameter is greater than 4mm and that there is no more than 40% calcification or
vascular stenosis in the femoral artery. If any of these occur, manual or mechanical
compression should be used. Most vascular closure devices can only be used if a ≤ 8F
sheath was used except in the case of the Perclose™ device (Azmoon et al., 2010).
Bangalore, Vidi, Liu, Shah and Resnic (2011) carried out a study deploying an extra-
vascular Starclose™ device with puncture sites at or within 3mm of the bifurcation
(which was 20% of their 1096 participants). They had non-significant numbers of
24
vascular complications when compared to access above the bifurcation with overall
vascular complication, both major and minor complications, at 1%. The authors
concluded that it was as safe to deploy a Starclose™ device at or near the bifurcation
as it was to deploy a device above the bifurcation. Therefore, it is perhaps the size of
the vessel and not the actual bifurcation itself that makes activation of the device
unsafe.
Cost
One downside to vascular closure devices is their cost (Chhatriwalla & Bhatt, 2006;
Galli & Palatnik, 2005). Dauerman et al. (2007) state the cost of the vascular closure
devices has dampened enthusiasm for their routine use. In New Zealand, the
Angioseal™ device (the vascular closure device most used in Capital and Coast Health
in Wellington) costs NZ$280 per patient (P. McKillop, personal communication, January
19, 2012).
Dauerman et al. (2007) suggests that cost effectiveness of vascular closure devices is
down to each individual interventional cardiology unit. Factors to take into account are
whether manual compression or devices such as Femostop™ to apply mechanical
compression are routinely used. If a hospital unit uses mechanical compression
routinely, which already comes at a cost, the step up to a vascular closure device use
would not be as great as those who use manual compression that doesn’t incur an
equipment cost. They suggest another factor to take into account is whether the
device, if no vascular complication occurs post-procedure, will mean a patient no
longer requires an overnight stay in hospital – another cost saving measure. Biancari et
al. (2010) agree and believe that the reduction of costs related to the use of vascular
closure devices is still to be demonstrated.
Operator learning curve
Since their introduction, most vascular closure devices have been through multiple
iterations to improve the devices. The operator learning curve to use each device is
steep (Dauerman et al. 2007), especially considering how complex placement of the
devices can be (Applegate et al., 2010). This can be seen in the study by Applegate et
al. (2006a) comparing rates of vascular complications between the first iteration of the
AngioSeal™ vascular closure device to the third iteration. The risk of a vascular
complication decreased 37%, which the authors put down to an increased operator
experience with using vascular closure devices (as well as improvements to the device
itself).
25
Malik (2008) reinforces that an adequate amount of training and management of
complications, to avoid an increase in vascular complications, must precede any new
device or iteration of a device. This training will take time, organisation and increased
cost to implement.
Vascular complications
There are significant complications that may arise with the use of vascular closure
devices that clinicians need to be aware of (Adusumilli et al., 2011). Complications after
placement of a vascular closure device can include femoral artery compromise,
laceration of the artery, bleeding, pseudoaneurysm, arteriovenous fistula, infection,
embolism and limb ischaemia (Dauerman et al., 2007).
Azmoon et al. (2010) also adds device malfunction requiring surgical intervention as a
complication. Ainslie, MacDonald and Smyth (2011) presented a case study of a 69-
year-old gentleman, who presented a month after coronary angiogram and placement
of a vascular closure device (AngioSeal™), with claudication to his right calf and
weaker pulse on his right leg. An MRI scan found a filling deficit to his right popliteal
artery. Vascular surgery found a collagen plug in his popliteal artery. When the
vascular plug was originally placed, haemostasis was not immediately gained.
Therefore, manual compression was required. The authors surmise that this manual
compression pushed the collagen plug into the artery, causing it to travel down to the
popliteal artery. Adusumilli et al. (2011) presented a very similar case in a 32-year-old
man who had the anchor, suture and collagen plug from an AngioSeal™ removed from
his right anterior tibial artery that was deployed two days earlier after a coronary
angiogram.
The impact of vascular closure devices on access site complications remains
controversial (Benninghoff, Amer & Klugherz, 2003). A review carried out by Dauerman
et al. (2007) looked at five different studies comparing manual compression to vascular
closure devices in diagnostic angiograms (Applegate et al., 2006a; Applegate et al.,
2006b; Arora, Matheny, Sepke & Resnic, 2006; Tavris et al., 2004; Tavris et al., 2005;).
Applegate et al. (2006a) showed no statistical difference in vascular complications after
diagnostic angiograms with vascular closure devices (1.2%) vs. manual compression
(1.4%). Similarly, Applegate et al. (2006b) found no differences with vascular closure
devices with respect to vascular complications (0.86%) vs. manual compression
(1.24%). Arora et al. (2006) however, did show a significant reduction in vascular
26
complications (58%) in diagnostic angiograms after vascular closure device usage vs.
manual compression. Tavris et al. (2005) had a similar finding with a statistically
significant reduction in vascular complications when a Vasoseal™ vascular closure
device was used post-diagnostic angiogram vs. manual and mechanical compression
groups (p<0.0001). An earlier study by Tavris et al. (2004) also looked at diagnostic
angiograms with vascular closure device use. Results in this study also showed a
statistical significance with a decrease in complications in diagnostic angiograms when
a suture based vascular closure device was used (p=0.0125) but not statistically
significant when a collagen plug device was used (p=0.10) when compared with
manual compression.
Sciahbasi et al. (2009) found that the radial approach had a significantly lower rate of
vascular complications (p=0.03). However, use of a femoral vascular closure device did
not significantly lower vascular complications in the femoral approach group
(Starclose™ 2.7%, Angioseal™ 3.9%) over manual compression group (2.9%) in their
study.
Applegate et al. (2010) found in their study of 575 participants after diagnostic
angiogram, that their vascular complication rate was only 0.2% after use of a vascular
closure device, with a deployment rate of 99.8%. This was using the new Evolution
AngioSeal™ that does not require the operator compaction of the anchor to collagen
sandwich, reducing operator variability as a cause of vascular complications.
In their study comparing manual compression to vascular closure devices post-
diagnostic angiogram, Lupi, Lazzero, Plebani, Sansa and Bongo (2011) found that
major vascular complication rates between the groups were not statistically significant
(1.1% in vascular closure device group vs. 0.4% in manual compression group).
However, when comparing minor complications between the groups, the vascular
closure device group had significantly more complications (5.5%) than the manual
compression group (2.7%; p=0.029).
Dauerman et al. (2007) conclude from their review that it is unsurprising that manual
compression remains the gold standard for achieving haemostasis. Studies on this
topic do not conclusively show that usage of a vascular closure device decreases the
risk of a vascular complication, and in some studies actually shows an increased risk.
Shroff (2011) agrees, stating that although vascular closure devices do reduce the time
to haemostasis and enable the patient to mobilise earlier, the vascular complication
27
rates after activation of these devices are similar to manual or mechanical compression
and in some cases even worse.
Summary
Femoral artery vascular closure devices are certainly a way to gain immediate
haemostasis and allow for earlier mobilisation (Chhatriwalla & Bhatt, 2006; Galli &
Palatnik, 2005). This earlier mobilisation has the potential benefit of improved patient
comfort and reduced back pain (Caputo et al., 2011; Narasimhan and Gabriel, 2011).
However, the devices have limitations. Not all patient’s anatomy is suitable for
placement of a device. Puncture sites can be situated where a device would not be
safe to place or can be too big for a device to safely seal the hole in the artery. The
devices are expensive, and depending on the usual practice of a unit, may not be cost
effective to use. Device operation can be difficult, with a steep operator learning curve
for placement of the device (Dauerman et al. 2007). If the operator is not sufficiently
skilled, this can lead to life or limb threatening consequences.
Many studies have been carried out on the rate of vascular complications after
placement of a vascular closure device. There is no conclusive evidence available that
says that the devices reduce complications, and in fact, some studies have shown an
increase in complications.
In summary, these devices are a good way to reduce back pain by allowing the patient
to mobilise earlier and a lot of cardiologists do use them in selected patients. However,
they cannot be used on everyone, and many operators choose not to use the devices
due to the increased costs, difficulty in using them and no clear benefit to the reduction
in vascular complications.
Early Mobilisation
Of all the factors found during the literature search, early mobilisation out of bed was
perhaps the most effective at reducing back pain due to prolonged bed rest. Back pain
severity increases the longer the patient remains on bed rest after coronary angiogram
and, conversely, the earlier the patient mobilises, the less back pain they experience
(Dabbs, Walsh, Beck, Demko & Kanaskie, 1999; Baum and Gantt, 1996; Vlasic, 2004;
Chair et al., 2003). Chair et al. (2007) recommends that to obtain optimal patient
comfort, the length of bed rest after a coronary angiogram should be minimized. It
28
seems logical that earlier ambulation could reduce some of the discomforts associated
with bed rest after a coronary angiogram, but this must be balanced against the need
for safety and prevention of vascular complications (Wang et al., 2001).
This literature review sourced 15 quantitative studies, published within the last 15
years, which directly researched early mobilisation of patients after femoral approach
diagnostic coronary angiography. The studies included 11 randomised controlled trials,
two quasi-randomised and two non-randomised trials, all with an intervention group
and control group.
All studies involved immediate sheath removal with no prerequisites except for no
bleeding or haematoma at site. Haemostasis was gained using either manual or
mechanical compression but did not include vascular closure devices. Occasionally, a
sandbag was utilized. Early mobilisation had varying time limits applied from 1.5 hours
to 4 hours compared to the control groups bed rest times of 3-24 hours. Medication use
varied between trials, but generally involved Aspirin, Heparin (and occasional reversal
with Protamine), Clopidogrel or Ticlodipine and low molecular weight Heparin. Warfarin
was usually stopped several days prior, and patients only included in trials if INR was
within normal limits.
Early mobilisation has many benefits to both the patient and unit. Patients who mobilize
earlier experience less back pain and discomfort. This literature review was specifically
looking at reduced back pain, which was evident in the four early mobilisation studies
that specifically measured and reported statistics on back pain and the six studies that
had anecdotal patient reports of decreased back pain. These results can be seen in the
Systematic Review in Chapter 4.
Early mobilisation proved to be very successful at reducing back pain after femoral
approach coronary angiogram, without increasing vascular complications, when
evaluated in the literature review. Earlier mobilisation also decreases urinary discomfort
due to the fact that using a bedpan or urine bottle whilst lying flat in bed can be difficult,
leading to urinary retention and discomfort (Chair et al., 2007). The intervention of early
mobilisation does not increase costs, and in fact could reduce costs (Best et al., 2010),
does not need any extra equipment or extra training, means an earlier regain of patient
independence and frees up nursing resources (Chair et al., 2007; Wang et al., 2001).
Koch et al. (1999) discuss how a patient who is mobilised sooner, without
complications, can be discharged earlier freeing up nursing resources and beds.
29
Because of these reasons, early mobilisation was chosen as the topic for the
Systematic Review in Chapter 4.
Conclusion
In this literature review, several different ways of reducing back pain after diagnostic
coronary angiogram were found. Knowing the patient factors that have the potential to
increase back pain, means the person caring for the patient may be able to pre-empt
and decrease the chances of that person developing back pain (perhaps prophylactic
pain relief etc.). The patient can be moved in bed or sit up in bed earlier to reduce their
back pain levels. A patient can be considered for a radial artery approach to their
coronary angiogram, meaning they can sit up and mobilise almost straight away after
the procedure. If a radial approach cannot be used, then a vascular closure device
could possibly be deployed after a femoral artery approach angiogram, to hasten
mobilisation.
The facts remain, however, that there are limitations to all of the above. The gold
standard and preferred access method around the world remains the femoral artery
(Hoglund et al., 2011) and vascular closure devices has not been widely adopted,
despite their availability (Dauerman et al., 2007). Of the five different ways to potentially
reduce back pain, only three (knowing the patient factors that have the potential to
increase back pain, moving the patient in bed or sitting them up in bed earlier and
earlier mobilisation) could be directly altered by a nurse without having to involve a
doctor. Earlier mobilisation proved to be the most successful way of the three at
reducing back pain when evaluated in the literature review. Decreasing the time to
mobilisation after femoral approach coronary angiogram, without vascular closure
device usage, seems the obvious solution to reducing back pain. But what is the
shortest time to mobilise these patients whilst maintaining their safety from vascular
complications? This is the question that the Systematic Review and Meta-Analysis in
Chapter 4 aims to answer.
This chapter has presented the studies reviewed in the literature search, discussed by
their main themes including patient factors that can affect back pain, position changes
whilst on bed rest, using a radial artery approach instead of femoral, using a femoral
artery vascular closure device and early mobilisation after the coronary angiogram. It
has shown that earlier mobilisation proved to be the most successful way that nurses
can use to reduce back pain when evaluated in the literature review. The next chapter
30
will discuss the decision to complete a Systematic Review on the topic of early
mobilisation after diagnostic coronary angiogram as the research component of this
nursing thesis. It will also discuss the Systematic Review process to be followed
(including ethical considerations).
31
Chapter 3
METHODOLOGY
The previous chapter explained how a thorough literature review revealed there were
five different ways of potentially decreasing patients back pain due to the bed rest
required after a femoral approach diagnostic coronary angiogram. As earlier
mobilisation proved to be very successful at reducing back pain after femoral approach
coronary angiogram, without increasing vascular complications, when evaluated in the
literature review, early mobilisation was chosen as the topic for further investigation
and research.
In this chapter, evidence-based practice (EBP) will be defined, the importance of the
nursing profession using EBP explained and how Systematic Reviews of randomised
controlled trials are the strongest level of evidence on which to base practice (Fineout-
Overholt et al., 2005). The decision to complete a Systematic Review on the topic of
early mobilisation after diagnostic coronary angiogram as the research component of
this nursing thesis will be discussed, an explanation given on the Systematic Review
process to be followed (including ethical considerations) and a discussion on how the
completion of this nursing based Systematic Review will be of benefit to nursing and
the evidence-based practice process.
Evidence-Based Practice
Evidence-based practice is the conscientious use of current best evidence from
relevant, valid research to guide practice decisions in the delivery of health care
(Fineout-Overholt et al., 2005; Joanna Briggs Institute, 2012). EBP involves finding,
critically appraising and applying scientific evidence to health care (Stevens, 2001)
through integration of the best available scientific evidence with experiential evidence
(Newhouse, 2007; Krugman 2012). The ultimate goal of EBP is to enhance the quality
of care provided to individuals, families, and communities and to improve overall health
outcomes. EBP also seeks to improve the performance of healthcare systems
(Newland, 2012).
Gawlinski (2008) and Cullen and Adams (2012) describe the process of evidence-
based practice, starting with the identification of a relevant clinical question that has
arisen from practice. From there, a thorough search takes place to identify the latest
research and evidence on the practice issue. The findings of this search are critiqued
32
and summarised and a proposal for change of practice is written. The evidence-based
practice change is implemented and the outcomes of the change evaluated and results
disseminated. This research process is carried out to generate a new knowledge base
with which to improve healthcare delivery, with the implementation of the empirical
evidence (Leasure, Stirlen & Thompson, 2008). Evidence-Based Practice and Nursing
Nurses play a pivotal role in the delivery of heath care forming the bulk of the clinical
health workforce (Flodgren, Rojas-Reyes, Cole & Foxcroft, 2012). They have the most
direct contact with patients and are in the best position to identify the gaps and
potential improvements in the delivery of health care (Newland, 2012).
Evidence-based practice is fundamental to the nursing profession (Newhouse, 2007).
Evidence-based nursing practice means using research and evidence to guide clinical
decision-making and not basing nursing care decisions on intuition or nursing tradition
(Leasure et al, 2008). Nursing practice based on research evidence has been shown to
improve health care quality and increase positive patient outcomes (Fink, Thompson &
Bonnes, 2005; Flodgren et al., 2012). It has been clearly shown that these outcomes
are at least 28% better when nursing care is based on rigorously designed research
than when care is based on tradition (Heater, Becker, & Olsen, 1988 as cited in
Fineout-Overholt et al., 2005). When given the necessary skills, any nurse can
participate in and be leaders for EBP initiatives (Newland, 2012).
By following the EBP process, nurses take ownership of their practices and transform
health care (Fineout-Overholt et al., 2005). By implementing EBP, nurses can be
assured that their patients are receiving safe care, there is a reduction in variations of
care from nurse to nurse or unit-to-unit, and positive patient outcomes are increased
(Fink et al., 2005; Leasure et al., 2008; Rickbeil & Simones, 2012). It has been shown
that nurses who are involved in applying evidence-based practice and practice
changes improve the quality of care. They develop professionally, think innovatively,
develop practice that is efficient, effective and improves patient outcomes, and they
become champions of change (Gawlinski and Becker 2012).
Systematic Reviews and Evidence-Based Practice
The establishment of evidence-based practice began in 1972, when a British
epidemiologist, Dr. Archie Cochrane, criticised the medical profession for “not providing
33
the public with rigorous systematic reviews of evidence from existing studies” (p. 336).
Because of Dr. Cochrane’s observations, the Cochrane Center was established in
1992, and followed a year later by the foundation of the Cochrane Collaboration
(Fineout-Overholt et al., 2005).
A hierarchy of evidence exists on which to base practice, ranked in order by the
strength of the evidence. Systematic Reviews of rigorous randomised controlled trials
sit at the top (level I evidence) and provide the strongest evidence. Level II evidence
includes at least one randomised controlled trial, level III a controlled trial with no
randomisation, a cohort or case control trial or a time series trial, down to level 4 which
includes expert opinions or descriptive studies (Leasure et al, 2008; Newhouse, 2007;
Nursing Research, 2012). Stevens (2001) describes how Systematic Reviews are
crucial in today’s paradigm of nursing following evidence-based practice. They have
been described by leaders in the field of EBP as “the most powerful and useful
evidence available” to guide practice (Stevens, 2001, p. 530).
Green et al. (2008) describe a Systematic Review as a collation of “all empirical
evidence that fits pre-specified eligibility criteria in order to answer a specific research
question” (p. 6). By using specific systematic methods with a view to minimizing bias,
trustworthy information is presented from which conclusions can be drawn and
decisions made.
A Systematic Review uses a transparent process to locate, evaluate and synthesise
the results of research using an explicitly defined process that has been prescribed in
advance. The process involves screening all available research for quality and
combining the findings of the studies. By following the Systematic Review guidelines,
the research process can be easily replicated and bias minimised (Campbell
Collaboration, 2012). Acton (2001) describe a Meta-Analysis as the combining of
statistical results from more than one study on a similar research issue, to produce a
pooled effect size and therefore to evaluate the effectiveness of the study interventions.
In simple terms, Systematic Reviews and Meta-Analysis are used to combine research
to provide important information for evidence-based practice. If the Systematic Review
or Meta-Analysis scientific process is not followed, combining the results of a number
of studies does not provide a reliable, scientifically derived evidence base for practice
(Stevens, 2001).
34
Thesis Methodology
Research Question
As mentioned in the previous chapter, a thorough literature review revealed there were
five different ways of potentially decreasing patients back pain due to the bed rest
required after a femoral approach diagnostic coronary angiogram. These were knowing
the patient factors that have the potential to increase back pain, position changes in the
bed whilst on bed rest, carrying out the angiogram through the radial artery instead of
the femoral allowing for earlier mobilisation, use of a femoral artery vascular closure
device (also allowing for earlier mobilisation), or simply allowing the patient to mobilise
earlier than the normal hospital unit protocol.
The research question asks whether it is safe for nurses to mobilise patients out of bed
four hours or earlier after a femoral approach coronary angiogram without the use of a
vascular closure device, in order to reduce back pain whilst not increasing the risk of
vascular complications at the puncture site and evolved from the literature review for
two reasons. Of the five different ways to potentially reduce back pain, only three could
be directly altered by a nurse without having to involve a Doctor. Then, because earlier
mobilisation proved to be the most successful way of the three at reducing back pain
when evaluated in the literature review, early mobilisation was chosen as the topic for
further investigation and research in the form of a Systematic Review.
Systematic Review and Meta-Analysis
As identified in Chapter 2, there were 15 studies already undertaken that directly
researched early mobilisation after femoral approach coronary angiogram. There was
one Systematic Review carried out on the topic, but it did not involve studies that were
published after 2007 (Chair et al., 2008). One of the 15 studies (Logemann et al., 1999)
identified that it included a Meta-Analysis of early mobilisation studies. However, it only
included a comparison of two studies to it’s own results and presented numbers and
percentages in a table and therefore was not a true Meta-Analysis.
Instead of carrying out further research on a topic that had already, clearly, been well
researched, a decision was made to perform a Systematic Review and Meta-Analysis.
By combining these 15 studies into a Systematic Review, the strongest and most
powerful evidence for which a nurse can base their practice on was produced. By
combining the statistical results from the studies into a Meta-Analysis, a pooled effect
35
and therefore important information for nurses and other health professionals was
found (Acton, 2001).
Systematic Review Framework
Through a literature search, several collaborations that are involved in producing
Systematic Reviews were located. The Joanna Briggs Institute, established in 1996, is
a research and development-based organisation situated at the University of Adelaide.
Although based in Australia, it involves an international collaboration of health
professionals including nursing, medical and allied health researchers. Their aim is to
provide reliable evidence with which health professionals can use to guide their clinical
decision-making. They have developed methods to appraise research, synthesise
evidence and produce Systematic Reviews and disseminate this information
internationally. They also promote evidence-based practice. This provides an
improvement of the health status of the global population, by enabling the health care
professional to deliver health care that is based on the best available evidence (Joanna
Briggs Institute, 2012).
The Cochrane Collaboration, founded in 1993, is an international organization with
over 15,000 contributors from more than 100 countries. The collaboration has the
primary aim of helping health care professionals make well-informed decisions about
care by preparing, maintaining and promoting the accessibility of Systematic Reviews.
These Systematic Reviews provide a reliable synthesis of the available evidence on a
given topic. Systematic reviews provide an accumulation of evidence, enabling the
health care professional to make care decisions considering all of the evidence on the
effect of an intervention (Cochrane Collaboration, 2008).
Two other institutions also prepare and provide a database of Systematic Reviews. The
Campbell Collaboration (2012) state they “prepare, maintain and disseminate
Systematic Reviews with a focus on education, crime and justice, and social welfare”
(para. 1). They don’t, however, have a health care focus. The Centre for Reviews and
Dissemination (2012) is part of the National Institute for Health Research in England.
They provide three databases and carry out Systematic Reviews on the effects of
health and social care interventions both in the United Kingdom and internationally.
When assessing all of the Systematic Review formats to be used as the framework for
the Systematic Review in this thesis, the Cochrane Collaboration was the organisation
36
that was found to be the most suitable due to it having a strong professional reputation,
a healthcare focus and a very clear structure to follow (outlined below).
The key characteristics of a Systematic Review using the Cochrane Collaboration
framework are a set of objectives with clearly stated eligibility for including and
excluding studies, a clear and easily duplicated methodology and a search strategy
that makes every attempt to locate all studies available to meet the inclusion criteria. All
studies must then be assessed for validity, including assessment for risk of bias. The
Review must be presented in a systematic way and the characteristics and findings of
the studies amalgamated (Green et al., 2008).
Search Strategy
The search strategy used in a Cochrane Systematic Review should be of a level that it
identifies every study that could possibly meet the study inclusion criteria (Green et al.,
2008). Lefebvre, Manheimer and Glanville (2008) discuss how the search for studies
will be determined by how the eligibility criteria are set. These criteria, in a Cochrane
Systematic review, include the types of study designs to be included, the participants to
be included, the types of interventions and control used and the types of outcomes to
be measured. The search strategy should be based around the main concepts of the
review. A typical search strategy to identify studies to be included in a Cochrane review
would include the population or health condition of interest, the intervention to be
evaluated and any filter to be added such as randomised trials.
Systematic Reviews using the Cochrane Collaboration framework typically focus
mainly on randomised controlled trials, due to the decreased chance of bias. However,
certain study designs are more suitable than others to answer specific research
questions. Also, restricting study types can lead to a smaller number of studies found,
whereas a more liberal criterion may lead to an increased number of studies but with
an increase in the chance of bias (O’Connor, Green & Higgins, 2008). A discussion on
the search strategy undertaken in this Systematic Review following the Cochrane
Systematic Review format is reported in the section entitled search methods. The
complete Systematic Review search strategy is outlined in Appendix II.
Data Extraction
Cochrane reviews need to be undertaken by more than one person. This is especially
important with the selection of studies and in the data extraction process. It is
37
suggested these reviewers work independently and then combine their data to
decrease the likelihood of errors. A third person may be required to help settle any
discrepancies between the original two reviewers (Green and Higgins, 2008).
Designing a data collection tool will be required, with ample time and thought invested
as it serves a very important function. More than one form may be required to collect
different types of data. This will need to be pilot tested using a representative sample of
the studies and then modified accordingly (Higgins and Deeks, 2008). The data
collection tool for this Systematic Review is included in Table 15 in Appendix IV (the
Systematic Review Protocol).
Risk of Bias and Quality Assessment of included studies
By rigorously assessing for risk of bias in the included studies, using the Cochrane
Collaboration Risk of Bias table (Higgins and Altman, 2008), more reliable results from
which conclusions and decisions can be made will be provided (Stevens, 2001).
Review authors will be required to make judgements about bias in studies, the overall
risk in a study and the relative importance of the different domains assessed (Higgins
and Altman, 2008).
The Cochrane Collaboration framework (Higgins and Altman, 2008) assesses six
different aspects of quantitative studies where bias can occur. Assessment of how the
participants in the study were allocated to either the intervention or control group using
a specified chance or random process (sequence generation) and that this allocation
has been concealed prior to assignment from both participants and investigators
(Allocation Sequence Concealment) is required. Evaluating whether blinding of both
participants and researchers from whether the intervention was received or not is
required, so that it can be seen that the intervention itself affected the outcome of the
study and not the knowledge of whether the intervention was received. Determining
whether a study has complete outcome data for all participants in the trial, including
those who withdrew from the study is necessary. If the data is not available, the study
should be assessed as to whether this is documented. Lastly, the study should be
assessed for selective outcome reporting. Often, studies with analyses where there are
significant differences between the interventional group and control group are more
likely to be reported than non-significant differences.
Other sources of bias were also addressed within the Systematic Review. Sensitivity
analysis involved analyzing the data as a whole and then re-analyzing only the studies
38
that were deemed to be of low risk of bias. In the case of this review, a secondary
analysis was undertaken that did not include the non-randomised or quasi-randomised
studies. Studies that show a positive outcome towards an intervention are more likely
to be published or published more quickly than a study that shows no benefit of the
interventional or a negative outcome from the intervention (Sterne, Egger & Moher,
2008). Therefore, studies were assessed for their overall result, whether it is positive,
negative or null and the time to publication from study completion was evaluated.
Duplication bias exists when a study is published more than once. Only one of the
publications was used in this review. Where there is more than one control group and
one interventional group, Sterne et al. (2008) recommends only including one
interventional group. If this does not occur, and a Meta-Analysis is undertaken, double
counting of the results of the control group can lead to bias. Funding bias was also
assessed in this review. Studies that have funding from companies who have a vested
interest in the result, such as pharmaceutical companies, can also lead to bias in the
results.
Critical Appraisal Tools
As stated earlier, a Systematic Review uses a transparent process to locate, evaluate
and synthesise the results of research using an explicitly defined process defined in
advance (Campbell Collaboration, 2012). The critical appraisal tool used as the
framework for this Systematic Review and Meta-Analysis was the Cochrane
Collaboration framework (Higgins and Green, 2008). This framework provides the
researcher with a clear guide to perform and present the review. Having a standard
review presentation format makes it easier for the reader of the review to follow the
process and results.
Assigning Levels of Evidence
As part of the Cochrane Review process, levels of quality of the evidence are allocated
to individual studies using the Grades of Recommendation, Assessment, Development
and Evaluation (GRADE) Working Groups grades of evidence. Using this tool, a
randomised controlled trial would be rated as high, a downgraded randomised trial as
moderate, a double downgraded trial or observational study as low and a triple
downgraded randomised trial or case report as very low. Further research would be
unlikely to change a reader’s confidence in the estimate effect if a trial was graded as a
high level study. Moderate quality studies would require further evidence to increase
confidence in the result of the particular trial. A reader would have little confidence in
39
the results of a study deemed to be of low or very low quality (Schunemann et al.,
2008). Each study in the Systematic Review has been through the GRADE process.
The levels of evidence of each study are presented in the Summary of Findings table
at the beginning of the Systematic Review. This is expanded on in the Quality of the
Evidence section in the Discussion of the Systematic Review.
Data Analysis and Synthesis
Meta-Analysis, combining the statistical results of at least two studies, is the most
common technique used in Cochrane Systematic Reviews. This Meta-Analysis focuses
on pair-wise comparisons such as comparing a new intervention to a control or two
new interventions. However, not all Systematic Reviews are suitable for Meta-Analysis.
If not, they will be presented as either a narrative or quantitative analysis. Deeks et al.
(2008) describe the effect, treatment effect or intervention effect of a study, as “the
contrast between the outcomes of two groups treated differently” (p. 244). However
they are analysed, synthesis of the studies should answer four questions. These
include the direction of the effect, the size of the effect, if the effect is consistent
between studies and the strength of the evidence of the effect. The first three questions
will be answered using statistics. The last question looking at the strength of the effect
will answered using judgements of the review author taking into account the study
design, risk of bias and statistical measures of uncertainty.
Studies brought together in a Systematic Review will be different in some way. This
difference is termed heterogeneity. Variability in studies can be in the participants,
interventions or outcomes (clinical heterogeneity), in the studies’ methods
(methodological heterogeneity) or in the interventional effects measured in the studies
(statistical heterogeneity). Heterogeneity, or differences between studies, can lead to
bias in the true interventional effect and therefore heterogeneity between studies must
be identified and measured. Only studies that are homogeneous (i.e. similar in their
participants, interventions, outcomes and study design) should be compared in a Meta-
Analysis, which will then provide meaningful results (Deeks et al., 2008).
Ethical Considerations
As this Systematic Review does not involve actual participant contact, ethics committee
approval was not required. However, a Research Notification Form (Appendix 5) and a
Low Risk Research Questionnaire (Appendix 6) were submitted to the Eastern Institute
40
of Technology’s Research Ethics and Approvals Committee. These forms were
accepted and the Committee agreed further ethical approval was not necessary.
Summary
This chapter defined evidence-based practice, the importance of the nursing profession
using EBP, and the decision to complete a Systematic Review on the topic of early
mobilisation after diagnostic coronary angiogram as the research component of this
nursing thesis. An explanation was given on the Systematic Review process to be
followed (including ethical considerations) and a discussion on how the completion of
this nursing based Systematic Review will be of benefit to nursing and the evidence-
based practice process was undertaken.
The next chapter includes the entire Systematic Review and Meta-Analysis, in the
format that would appear on the Cochrane Collaboration database of Systematic
Reviews. It follows the Cochrane Collaboration framework and is presented as if it were
a separate piece of work for publication on the Cochrane Collaboration database. The
Systematic Review Protocol, which is the initial research proposal that would be sent to
the Cochrane Collaboration, sits in the Systematic Review as Appendix IV.
41
Chapter 4
SYSTEMATIC REVIEW
Table of Contents
Abstract 42 Plain language summary 43 Summary of findings 45 Background 46 Objectives 47 Methods 47 Search methods for identification of studies 48 Data collection and analysis 49 Results 51 Effects of interventions 56 Discussion 62 Authors conclusions 64 Acknowledgements 65 Declarations of interest 65 Differences between protocol and review 65 References 65
Table 1 Summary of Findings 45 Table 2 Risk of Bias in Included Studies 55 Table 3 Summary of Interventions in Early Mobilisation Trials 61 Table 4 Characteristics of Included Studies 69 Table 5 Characteristics of Excluded Studies 85 Table 6 ≤ 2 hours bed rest - total bleeding complications 86 Table 7 ≤ 2 hours bed rest - total vascular complications 87 Table 8 ≤ 3 hours bed rest - total bleeding complications 88 Table 9 ≤ 3 hours bed rest - total vascular complications 89 Table 10 ≤ 4 hours bed rest - total bleeding complications 90 Table 11 ≤ 4 hours bed rest - total vascular complications 91 Table 12 Results Randomised Controlled Trials Only 92 Table 13 Results – All Included Studies 93 Table 14 Risk of Bias Assessment Tool 101 Table 15 Data Collection Tool 101
Appendix I Flowchart for Inclusion / Exclusion of Studies 94 Appendix II Search Strategies 95 Appendix III Criteria and Definitions for Risk of Bias Assessment 96 Appendix IV Systematic Review Protocol 98
42
Early mobilisation after femoral approach diagnostic coronary angiography to reduce back pain
Kelly L. Burn1, Bob Marshall2, Gill Scrymgeour2
1Interventional Cardiology, Capital and Coast Health District Health Board, Wellington,
New Zealand
2Eastern Institute of Technology, Taradale, Napier, Hawke’s Bay, New Zealand
Contact address: Kelly Burn, Interventional Cardiology, Wellington Hospital, Riddiford
Street, Newtown, Wellington, New Zealand. Kelly.Burn@ccdhb.org.nz
43
Abstract
Background:
Coronary heart disease accounts for over 25,000 inpatient admissions and nearly
4,000 day-case admissions in New Zealand per year (Hay, 2004). Cardiac
catheterization, via the femoral artery, is a common procedure undertaken to assess
for and treat coronary heart disease (Chair, Li and Wong, 2004; Chandrasekar et al.,
2001; Wang, Redeker, Moreyra & Diamond, 2001). After the procedure, the patient
remains on bed rest (mainly supine with the affected leg straight) for at least a further
4-6 hours (Sabo, Chlan and Savik, 2008) intended to reduce the chances of
complications at the groin site (Chair, Taylor-Piliae, Lam and Chan, 2003). Due to this
enforced supine bed rest, immobilization and restricted positioning, patients frequently
experience back pain (Chair et al., 2003). Prolonged bed rest causes pressure to be
exerted continuously onto the same back muscles, causing muscle fatigue and
weakness. This fatigue causes back pain due to back spasms (Chair et al., 2004).
Objectives:
To ascertain if it is safe for nurses to mobilise patients out of bed four hours or earlier
after a femoral approach coronary angiogram without the use of a vascular closure
device, in order to reduce back pain whilst not increasing the risk of vascular
complications at the puncture site.
Search strategy:
A computer search of the databases MEDLINE, Wiley InterScience, CINAHL, PubMed,
Proquest Central, Google Scholar, Science Direct and Cochrane Database of
Systematic Reviews was carried out. Reference lists of already acquired research were
also searched.
Selection criteria:
All randomised controlled trials (RCT’s), quasi-randomised and non-randomised
controlled trials found in the literature search, that compared the safety of early
mobilisation with vascular complications after femoral approach diagnostic coronary
angiogram, were considered for inclusion in the review. In all 15 studies from around
the world, published since 1996, were chosen.
44
Data collection and analysis:
Once studies had been obtained, they were vetted against the inclusion and exclusion
criteria for this review. The article was thoroughly scrutinised and if it was suitable was
included in the data collection. Three assessors evaluated the studies and reasons for
inclusion or exclusion. This reduced the chance of selection bias in the review. Risk
ratios and 95% confidence intervals were calculated for all studies.
Main results:
Six trials looked at mobilisation at 2 hours or earlier after a diagnostic angiogram.
There was no significant difference overall in incidence of bleeding, haematoma or
pseudoaneurysm in these studies, with results slightly favouring the control group (RR
1.1591; 95% CI 0.7544-1.7809; p = 0.5023). Ten studies looked at the safety of
mobilisation after ≤ 3 hours with no statistical significance in the overall figures, with
results favouring the experimental group (RR 0.8430; 95% CI 0.7041-1.0094; p =
0.0625). All fifteen studies observed mobilisation ≤ 4 hours, again with no statistical
significance in figures, again with results favouring the experimental group (RR 0.8696;
95% CI 0.7399-1.0219; p = 0.0891).
Authors’ conclusions:
The results from this study show no statistically significant difference in vascular
complications between the control and experimental groups who mobilised at less than
two, three or four hours post femoral approach coronary angiogram. Therefore,
mobilisation after coronary angiogram may be as safe at one and a half to four hours
mobilisation as it is at six hours and may have a positive benefit of reducing back pain
related to lying in bed.
Plain Language Summary
Getting out of bed earlier to reduce back pain after a procedure to look at the arteries
of the heart
A coronary angiogram is a procedure undertaken to visualise the arteries of the heart,
looking for any area of narrowing that may need treatment. It is commonly undertaken
via the femoral artery in the groin, which means the patient must remain on bed rest for
a period of time afterwards to decrease the chances of bleeding from the femoral artery.
This bed rest commonly leads to the patient experiencing back pain.
45
This review aims to find the least amount of time the patient must stay in bed whilst
keeping the risk of bleeding low. The earlier the patient gets out of bed, the less back
pain they will potentially experience. The 15 trials involved patients mobilising out of
bed between one and a half and four hours after the procedure. The review finds that it
is probably safe to get patients out of bed two hours after the procedure whilst keeping
the risk of bleeding low.
46
Table 1: Summary of findings:
Early mobilisation after femoral approach diagnostic coronary angiography to reduce back pain
Patients or population: Any adult patient undergoing a diagnostic coronary angiogram via a femoral artery approach
Settings: Cardiac catheterisation units Intervention: Earlier mobilisation after procedure than standard protocol
Comparison: Mobilisation after procedure at normal time
Outcomes Numbers (Experimental/Control)
Total Number Vascular Complications (Experimental/Control)
Risk Ratio (95% CI)
P-value
Quality of the evidence
≤2 vs. 3-6 hours bed rest 699 / 831
(6 studies)
39 / 40 1.1591
(0.7544 -1.7809)
0.5023
moderate 1, 4
≤3 vs. 4-6 hours bed rest 1910 / 2017
(10 studies)
190 / 238 0.8430
(0.7041-1.0094)
0.0625
moderate 1, 2, 4
≤4 vs. ≥6 hours bed rest 2237 / 2344
(15 studies)
239 / 288 0.8696
(0.7399-1.0219)
0.0891
moderate 1, 2, 3, 4
GRADE Working Group grades of evidence (Schunemann et al., 2008)
High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
1 Best et al. (2010) used a non-randomised controlled design and Roebuck et al. (2000) used quasi-randomised controlled design which may have increased risk of bias 2 Mah et al. (1999) used non-randomised controlled design which may have increased risk of bias 3 Wang et al. (2001) used quasi-randomised controlled design and may have increased risk of bias 4 None of the 15 included studies had complete allocation concealment or blinding which may increase bias
47
Background
Description of the condition
Coronary heart disease remains the leading cause of death in New Zealand at 21%,
with rates of cardiovascular disease mortality in Maori people two and a half times the
rate of other New Zealanders (Ministry of Health, 2011). It accounts for over 25,000
inpatient admissions and nearly 4,000 day-case admissions in New Zealand per year
(Hay, 2004). Although rates of death related to ischaemic heart disease are reducing
every year in New Zealand, the rate of reduction has progressively slowed, most likely
related to the increase of obesity and type 2 diabetes (Tobias, Sexton, Mann & Sharpe,
2006).
Description of the intervention
Coronary angiography involves injection of a radiopaque contrast media into the
coronary arteries under fluoroscopy allowing visualisation of the coronary anatomy and
therefore pathologies such as atherosclerosis, thrombosis and patency of any coronary
artery bypass grafts (Asinas, 2010). Trans-femoral puncture via a 5F to 8F sheath is
the most common approach, but the brachial and radial arteries can also be used
(Chair, Thompson and Li, 2007).
They are many differences in practices for care post-angiogram (Wang et al., 2001).
Arterial femoral sheaths post-diagnostic angiograms are generally removed
immediately post procedure (Lauck, Johnson and Ratner, 2005). After sheath removal,
haemostasis is most often maintained with manual compression using digital pressure
or an adjunctive mechanical compression device. The patient then remains on bed rest
(mainly supine with the affected leg straight) for a further 4-6 hours in a diagnostic
procedure (Sabo et al., 2008) intended to reduce the chances of vascular
complications at the groin site (Chair et al., 2003).
Why it is important to do this review
Due to this enforced supine bed rest, immobilization and restricted positioning, patients
frequently experience back pain (Chair et al., 2003). Prolonged bed rest causes
pressure to be exerted continuously onto the same back muscles, causing muscle
fatigue and weakness. This fatigue causes back pain due to back spasms (Chair et al.,
2004). It is evident back pain is a significant issue faced by patients on bed rest after a
coronary angiogram (Chair et al., 2007; Hoglund, Stenestrand, Todt & Johansson,
48
2011; Pollard et al., 2003; Wang et al., 2001; Wood et al., 1997). Rezaei-Adaryani,
Ahmadi and Asghari-Jafarabadi (2009) have suggested that bed rest and positioning
regimes after coronary angiogram are based on tradition rather than research. This
review aims to provide an evidence-based argument that time to mobilisation can be
decreased in patients post femoral approach diagnostic coronary angiogram with low
risk of vascular complications. This in turn will help to decrease or prevent the potential
for back pain occurring.
Objectives
The aim of this Systematic Review and Meta-Analysis to ascertain whether it is safe for
nurses to mobilise patients out of bed four hours or earlier after a femoral approach
coronary angiogram without the use of a vascular closure device, in order to reduce
back pain whilst not increasing the risk of vascular complications at the puncture site.
Methods
Types of studies
This review included randomised controlled trials (RCT), non-randomised controlled
trials and quasi-randomised controlled trials. There was no minimum number of trial
participants set and the study could come from any country as long as it was published
in English. There was a 15 year limit applied to the studies i.e. they needed to have
been published in 1996 or later to be included.
Types of Participants
The study included those with both male and female participants aged over 18 years.
They were of many different ethnicities and from many different countries. The
participants could include outpatients or acute inpatients.
Types of Interventions
The participants in the studies had received a femoral approach diagnostic coronary
angiogram with a sheath sized between 5F and 8F. The studies needed to test the
intervention of early mobilisation after femoral approach diagnostic coronary angiogram
whilst assessing levels of vascular complications. Secondary measurement of back
pain in each group of a trial was an advantage.
49
The study was not included if the participants received a diagnostic coronary
angiogram through an artery other than the femoral artery i.e. brachial or radial artery
or a simultaneous percutaneous coronary intervention (PCI). Studies where
participants received angiograms to other parts of the body not including the heart
where also excluded. Studies where patients were treated with a vascular closure
device were excluded.
Types of Outcome Measures
The primary outcome measures for this review were vascular complications including
bleeding, haematoma (including retroperitoneal haematoma) and pseudo-aneurysm.
For an intervention to have been successful, the rate of complications in both the
control and intervention group cannot be statistically significant or must favour the
experimental group, if there is a statistical significance.
The secondary outcome measures for this study included levels of back pain,
discomfort and patient satisfaction. For an intervention to have been successful, there
needed to be a statistically significant reduction in back pain or discomfort and a raised
level of patient satisfaction in the experimental group. Search methods for identification of studies
Electronic searches
For this study, a computer search of the databases available at the Eastern Institute of
Technology Twist Library and the Otago University Library were used. They included
MEDLINE, Wiley InterScience, CINAHL, PubMed, Proquest Central, Science Direct
and Cochrane Database of Systematic Reviews. The full search strategies for each
database are outlined in Appendix 2.
Other sources
Reference lists of already acquired research were also searched and the studies
obtained from the above databases. Several of the journals did not provide access to
older archive studies that still met my criteria and so these institutions were emailed
and provided the archived studies.
50
Data collection and analysis
Selection of studies
Through a thorough literature search, 709 studies were considered for use in this
review. After reading the abstracts of these articles, 18 were considered to be
potentially usable and the full-text articles were obtained. They were then vetted
against the inclusion and exclusion criteria for this review. Firstly, the abstract was read,
and if the study fit the criteria then the full article was sought. The article was
thoroughly scrutinised and if it was deemed suitable by all three assessors, it was
included in the data collection. If the article was not suitable, it was entered into the
Characteristics of Excluded Studies list and reasons why it was not included thoroughly
documented.
Data extraction and management
Relevant data for this review was extracted from the 15 included studies via a data
collection tool. This data included source information, the studies methodology, a
scrutinisation of the risk of bias within the study, information on patient demographics
and inclusion and exclusion criteria for participants. The interventions that each arm of
the study received and the results of these interventions were also gathered, as was
general information about the study such as conflicts of interest, ethics information,
funding sources and stated study limitations.
Risk of bias assessment
The risk of bias was assessed by all three of the review authors, with a consensus
used when disagreements occurred. The Cochrane Collaboration’s tool for assessing
bias (Higgins & Altman, 2008) was used to assess the risk of bias of the selected
randomised controlled trials. The criteria and their definitions are outlined in Appendix 3.
Each of the criteria was scored ‘yes’, ‘no’ or ‘unclear’, depending on the information
supplied in the report. The Risk of Bias summary table for this review is shown in the
Results section.
Data analysis
Separate analyses were carried out for the different time frames to mobilisation post-
angiogram comparing rates of vascular complications. Analyses were undertaken for
levels of back pain at each of these time frames, if they were measured in the studies.
51
Data synthesis
Studies were analysed for homogeneity looking at study participants, interventions and
outcome measures. Studies that had similar homogeneity were combined into the
three separate analyses based on time to mobilisation. Data on back pain measures
between groups was also analysed.
Measurements of intervention effect
For dichotomous data, the results were presented as risk ratio (RR) with 95%
confidence intervals (CI). For calculation of statistical significance, a two-tailed Fisher
Exact Test was used. In the case of a sample size too large for the Fisher test, a
Pearson Chi-Squared Test was used. Statistical significance was set at p ≤ 0.05.
Assessment of heterogeneity
Because all studies were looking at complication rates, they were considered to be
comparable and therefore did not require further assessment of heterogeneity.
Sensitivity analysis
After the initial analysis, each time frame was re-analysed including only studies
assessed as having a low risk of bias to find out if the risk of bias altered the initial
results. This meant each of the three timeframes had three separate analyses –
randomised controlled trials, non-randomised and quasi-randomised controlled trials
and all included trials.
Dealing with missing data
Two authors were contacted to provide missing data. In Mah, Smith and Jensen (1999)
it was unclear as to whether vascular complications occurred before or after
mobilisation. Jensen provided the additional information that confirmed all
complications occurred after mobilisation. The same information was missing from
Pollard et al (2003). However, they did not respond to an email sent. Mention was
made of this under Other Potential Bias in the Results section below.
Assessment of reporting bias
Publication bias: Of the 15 studies included in this systematic review, eight studies
showed a positive overall result towards early mobilisation (Bogart, Bogart, Rigden,
Jung & Liston, 1999; Chair et al., 2007; Farmanbar et al., 2008; Logemann, Luetman,
52
Kaliebe, Olson & Murdock, 1999; Mah et al., 1999; Roebuck, Jessop, Turner & Caplin,
2000; Singh, Kuganesan, Goode & Ricci, 1998; Wang et al., 2001; Wood et al., 1997)
and six studies showed a negative overall result towards early mobilisation (Baum and
Gantt, 1996; Best, Pike, Grainger, Eastwood & Carroll, 2010; Hoglund et al., 2011;
Keeling, Taylor, Nordt, Powers & Fisher, 1996; Lim et al., 1997; Pollard et al., 2003).
However, only one study showed statistical significance with a two-tailed Fishers Exact
Test of p = 0.00002, which was in favour of early mobilisation when the p-value of ≤
0.05 is used as the level of significance (Mah et al., 1999).
Time lag bias: Three of the 15 studies mentioned the study duration (Farmanbar et al.,
2008; Hoglund et al., 2011; Singh et al., 1998). The time of data collection from these
studies ranged from 6 months to one year. Each was published between one and two
years after data collection finished. The other 12 studies did not mention times, so time
lag bias could not be assessed.
Duplication bias: Only one study was found to have two publications of the same study.
In the case of Chair et al. (2007), her full Doctoral Thesis was published earlier as
Chair (2004). For the purpose of this systematic review, Chair et al. (2007) was used.
Studies with more than two interventional groups: Singh et al. (1998) contained a
control group (mobilisation at 6 hours) and two experimental groups (earlier
mobilisation at 3 hours and 4 hours). To decrease risk of bias due to double counting of
the control group figures in the overall Systematic Review, only the 3-hour group and
the comparison 6-hour control group were used in the analysis.
Funding bias: Of the 15 studies, five declared their funding sources (Best et al., 2010;
Logemann et al., 1999; Pollard et al., 2003; Singh et al., 1998; Wang et al., 2001).
None of the studies would be assessed as having funding bias, as all five involved
funding from research foundations, mainly from within the hospital the research was
set. The other ten studies either did not receive any funding or did not declare it.
Results
Description of studies
See: Characteristics of included studies; Characteristics of excluded studies.
A total of 15 studies were identified that met the inclusion criteria. A further three were
excluded for reasons documented in the Characteristics of Excluded Studies table. The
53
included studies contained a total of 4581 participants, 2237 in experimental groups
and 2344 in control groups. The studies were published from 1996 – 2011.
Of these 15 studies, 11 were randomised controlled trials and four were quasi-
randomised or non-randomised with a control group. The Characteristics of Included
Studies table shows the summary of the methods, participants, interventions,
outcomes and risk of bias of each included study (Baum & Gantt, 1996; Best et al.,
2010; Bogart et al., 1999; Chair et al., 2007; Farmanbar et al., 2008; Hoglund et al.,
2011; Keeling et al., 1996; Lim et al., 1997; Logemann et al., 1999; Mah et al., 1999;
Pollard et al., 2003; Roebuck et al., 2000; Singh et al., 1998; Wood et al., 1997; Wang
et al., 2001). Inclusion criteria for all studies consisted of adult participants (both male
and female) who were to undergo diagnostic coronary angiogram via a femoral
approach. The extensive exclusion criteria from each study can be viewed in The
Characteristics of Included Studies table.
The studies reported on five different times to mobilisation in the experimental groups
that were condensed into three separate time analyses. These time analyses were ≤ 2
hours, ≤ 3 hours and ≤ 4 hours. The control groups mobilised at a time frame greater
than the experimental group (between 3 and 6 hours).
Four studies directly measured back pain in their study groups (Chair et al., 2007;
Hoglund et al., 2011; Wang et al., 2001; Wood et al., 1997). Six other studies
mentioned feedback from participants in groups with a shorter time to mobilisation,
about level of back pain, comfort or satisfaction, without directly measuring it (Baum
and Gantt, 1996; Best et al., 2010; Logemann et al., 1999; Mah et al., 1999; Pollard et
al., 2003; Roebuck et al., 2000). Logemann et al. (1999) gave participants a
satisfaction survey that asked patients if they experienced any pain and whether they
were satisfied with the procedure. It did not, however, measure solely back pain.
Roebuck et al. (2000) did not measure back pain specifically but randomly pulled
charts from 100 participants (50 per group) and compared intravenous analgesia rates
between the groups.
Seven studies were undertaken in the United States of America, three in Canada, two
in the United Kingdom and one each in Hong Kong, Sweden and Iran. All studies took
place in just one facility. Study length varied throughout the trials, from between 3
months and 24 months. Wang et al. (2001) had the lowest number of total participants
at 82 amongst the studies, with Mah et al. (1999) the highest with 880 total participants.
54
The participants in all studies included both males and females aged over 18 years.
Risk of bias in included studies
Details of the results of the risk of bias assessment of each individual included study
are shown in Table 2.
Randomisation - Of the 15 included trials, 11 used a methodology of a randomised
controlled trial. Only two of these described their randomisation process. Chair et al.
(2007) used a computer randomisation and Wood et al. (1997) used a dice throw. The
other nine randomised controlled trials did not mention by what method they achieved
randomisation (Baum et al., 1996; Bogart et al., 1999; Farmanbar et al., 2008; Hoglund
et al., 2011; Keeling et al., 1996; Lim et al., 1997; Logemann et al., 1999; Pollard et al.,
2003; Singh et al., 1998). There were two non-randomised controlled trials where the
control group was decided by a retrospective analysis of data, prior to a change in
protocol (Best et al., 2010; Mah et al., 1999). The experimental group was allocated the
new protocol for a similar length of time as the retrospective analysis. The two other
studies used a quasi-randomised method where the participants were allocated week
about to the experimental or control group (Roebuck et al., 2000; Wang et al., 2001).
Allocation – Two of the trials (Lim et al., 1997, Roebuck et al., 2000) made a statement
about allocation sequence concealment. In their studies, only the operator performing
the procedure was blinded from allocation. Wang et al. (2001) stated they blinded
participants until after the coronary angiogram had finished. None of the other 12 trials
stated whether they had allocation concealment.
Blinding – It would be difficult with the design of these studies to blind the participants
and personnel directly involved in the participants care from sheath removal until
discharge. However, medical staff performing the procedure and outcome assessors
could be blinded to reduce study bias. Pollard et al. (2003) declared they used an open
trial design with no blinding. Singh et al. (1998) mentioned they used a single blinding
method but not who was actually blinded. None of the other 14 studies mentioned
blinding of study participants, medical and nursing staff or outcome assessors.
Incomplete outcome data – All studies presented outcomes for all of the participants in
their trials. All trials presented figures for all patients at discharge. Not all trials followed
up patients after discharge. Two trials that had a loss to follow up after discharge
55
declared this (Logemann et al., 1999; Mah et al., 1999).
Other potential bias – It was unclear as to whether vascular complications occurred
before or after mobilisation in Pollard et al (2003). However, figures were given for the
same time periods for both the control and experimental group. There was no other
potential bias determined in any of the studies. In each study, the participants
remained in the groups to which they were allocated, the reports were free of selective
outcome reporting and no other risk for bias was established.
56
Table 2. Review authors’ judgments for each risk of bias item for each study.
Stu
dy ID
Stu
dy d
esig
n
Was
the
allo
catio
n se
quen
ce ra
ndom
ly
gene
rate
d?
Was
allo
catio
n ad
equa
tely
con
ceal
ed fr
om
both
par
ticip
ants
and
clin
icia
ns b
y ha
ving
a
secu
re s
ched
ule
of ra
ndom
izat
ion?
Wer
e pa
rtici
pant
s, c
linic
ians
and
out
com
e as
sess
ors
blin
ded
to th
e al
loca
ted
inte
rven
tion
adeq
uate
ly d
urin
g th
e st
udy?
Are
resu
lts re
porte
d fo
r eve
ryon
e w
ho
ente
red
the
trial
?
Was
inco
mpl
ete
outc
ome
data
ade
quat
ely
addr
esse
d?
Wer
e pa
tient
s an
alys
ed in
the
grou
ps to
w
hich
they
wer
e ra
ndom
ised
?
Are
repo
rts o
f the
stu
dy fr
ee o
f sel
ectiv
e ou
tcom
e re
porti
ng?
Was
the
stud
y ap
pare
ntly
free
of o
ther
pr
oble
ms
that
cou
ld p
ut it
at a
hig
h ris
k of
bi
as?
Baum 1996 RCT ✔ ? ? ✔ ✔ ✔ ✔ ✔
Best 2010 N-RCT ✗ ? ? ✔ ✔ ✔ ✔ ✔
Bogart 1999 RCT ✔ ? ? ✔ ✔ ✔ ✔ ✔
Chair 2007 RCT ✔ ? ? ✔ ✔ ✔ ✔ ✔
Farmanbar 2008 RCT ✔ ? ? ✔ ✔ ✔ ✔ ✔
Hoglund 2011 RCT ✔ ? ? ✔ ✔ ✔ ✔ ✔
Keeling 1996 RCT ✔ ? ? ✔ ✔ ✔ ✔ ✔
Lim 1997 RCT ✔ ? ✗ ✔ ✔ ✔ ✔ ✔
Logemann 1999 RCT ✔ ? ✔ ✔ ✔ ✔ ✔ ✔
Mah 1999 N-RCT ✗ ? ? ✔ ✔ ✔ ✔ ✔
Pollard 2003 RCT ✔ ✗ ✗ ✔ ✔ ✔ ✔ ✔
Roebuck 2000 Q-R ? ? ✗ ✔ ✔ ✔ ✔ ✔
Singh 1998 RCT ✔ ? ✗ ✔ ✔ ✔ ✔ ✔
Wang 2001 Q-R ? ✗ ? ✔ ✔ ✔ ✔ ✔
Wood 1997 RCT ✔ ? ? ✔ ✔ ✔ ✔ ✔
✔ - Yes ✗ - No ? – Unclear (Explained in Appendix 3. Criteria and definitions for risk of bias assessment)
RCT – Randomised controlled trial N-RCT – Non-randomised controlled trial Q-R - Quasi-randomised controlled trial
57
Effects of interventions
≤ 2 hours bed rest post-diagnostic coronary angiogram
Six trials with 1530 total participants (699 experimental / 831 control) reported results
on mobilisation out of bed at or before 2 hours post femoral approach diagnostic
coronary angiography. Measures of bleeding, haematoma and pseudo-aneurysm were
presented and analysed. There were 78 incidences of bleeding or haematoma overall,
with 39 in both the experimental groups and control groups (RR 1.1888; 95% CI
0.7716-1.8318; p = 0.4310). There was only one pseudoaneurysm in any of the studies
in this time frame, occurring in the control group.
Overall, vascular complications occurred in 79 participants with 39 in the experimental
groups mobilised at or before 2 hours and 40 occurring in the control groups mobilised
between three and six hours post-procedure. These results favoured the control group
but not with any statistical significance (RR 1.1591; 95% CI 0.7544-1.7809; p = 0.5023).
Four of the trials used a randomised controlled trial methodology. Overall results of
these studies, when separated from the one trial with a quasi-randomised controlled
methodology and one with a non-randomised controlled trial methodology, showed
similar figures favouring the control group but again with no statistical significance (RR
1.0746; 95% CI 0.6073-1.9012; p = 0.8763).
Of the six studies, three showed total vascular complication rates that favoured the
control group and three the earlier mobilisation experimental group. However, none of
the overall vascular complication rates in any of the studies showed a statistical
significance.
≤ 3 hours bed rest post-diagnostic coronary angiogram
Out of the total 15 studies included in the review, 10 mobilised their participants out of
bed at or before three hours. These studies included a total of 3927 participants (1910
experimental / 2017 control). Again, measures of bleeding, haematoma and pseudo-
aneurysm were presented and analysed. There were 189 incidences of bleeding or
haematoma in the experimental groups mobilising at or before three hours and 234 in
the control groups mobilising after three hours (RR 0.8529; 95% CI 0.7116-1.0224; p =
0.0848). There was one pseudoaneurysm in the experimental groups and four in the
control groups.
58
Overall, vascular complications occurred in 428 participants. This included 190
mobilised at or before 3 hours and 238 in the control groups. The overall results
favoured the experimental group, although the figures were not quite statistically
significant (RR 0.8430; 95% CI 0.7041-1.0094; p = 0.0625).
Seven of the trials used a randomised controlled trial methodology. Overall results of
these studies, when separated from the one trial with a quasi-randomised controlled
methodology and two trials with a non-randomised controlled trial methodology,
showed figures that slightly favoured the control group but again with no statistical
significance (RR 1.0023; 95% CI 0.7818-1.2849; p = 1.000).
Of the ten studies, six showed total vascular complication rates that favoured the
earlier mobilisation experimental group and four the control group. One study showed
an overall statistical significance. Mah et al. (1999) showed, in their non-randomised
controlled trial, results that significantly favoured the experimental group who mobilised
out of bed at three hours (RR 0.5332; 95% CI 0.3961-0.7177; p = 0.00002). None of
the overall vascular complication rates in any of the other studies showed a statistical
significance.
≤4 hours bed rest post-diagnostic coronary angiogram
All of the 15 studies included in this review mobilised the participants in their
experimental groups out of bed at or before four hours. This included a total of 4281
participants (2237 experimental / 2344 control). There were 238 incidences of bleeding
or haematoma in the experimental group and one pseudoaneurysm. There were 282
incidences of bleeding or haematoma and six pseudoaneurysms in the control groups.
Overall bleeding results favoured the experimental groups but with no statistical
significance (RR 0.8843; 95% CI 0.7517-1.0404; p=0.1380).
Overall at this time frame, vascular complications occurred in 527 participants (239
experimental / 288 control). The overall vascular complication results favoured the
experimental group, although the figures were again not quite statistically significant
(RR 0.8696; 95% CI 0.7399-1.0219; p = 0.0891).
Eleven of the trials used a randomised controlled trial methodology. Overall results of
these studies, when separated from the two trials with a quasi-randomised controlled
methodology and the two trials with a non-randomised controlled trial methodology,
59
showed figures that slightly favoured the control group but again with no statistical
significance (RR 1.0361; 95% CI 0.8440-1.2719; p = 0.7401).
Within the fifteen studies included in the review, nine showed overall vascular
complication rates that favoured the early mobilisation experimental groups and six
showed results that favoured the control groups. Comparing mobilisation out of bed at
three hours versus five hours, Mah et al. (1999) was the only study to display statistical
significance in their results. As stated above, their non-randomised controlled trial
displayed results that significantly favoured the experimental group (RR 0.5332; 95%
CI 0.3961-0.7177; p = 0.00002). None of the overall vascular complication rates in any
of the other fifteen included studies showed a statistical significance.
Measured back pain
Four studies directly measured back pain in both the experimental and control groups
(Chair et al., 2007; Hoglund et al., 2011; Wang et al., 2001; Wood et al., 1997). There
was no standardized timing to gathering this information between the studies, so a
comparative analysis could not be done. However, tools used to measure the back
pain were similar. Chair et al. (2007) used a visual analogue scale 100mm long, left
anchor at 0mm no pain. A numeric rating scale of 0 – 10 (0 meant no pain or
discomfort or least possible satisfaction) was used by Hoglund et al. (2011) and Wang
et al. (2001). Wood et al. (1997) simply asked patients if they had back pain or leg
stiffness or not just prior to mobilisation.
Wood et al. (1997) found that 14% of participants complained of back pain or leg
stiffness in their early mobilisation group at 2 ½ hours compared to their 4 hour
mobilisation group with 42% of participants experiencing pain or stiffness. Wang et al.
(2001) however, got the opposite results. Their early mobilisation group of 4 hours
experienced more back pain than their 6-hour control group (average back pain 3.29
experimental group vs. 2.85 control group). This result may be the due to the inclusion
of three patients with chronic back pain in their experimental group who rated their
back pain 9 – 10, pushing the average figure of the experimental group much higher.
Hoglund et al. (2011) measured back pain at eight different intervals from sheath
removal to follow up 48 hours after discharge. At the end of bed rest, ten patients in the
experimental group rated their pain 1 – 4 and one patient 5 – 6. In the control group,
twenty patients rated their pain 1 – 4; seven patients rated 5 – 6 and four patients 7 – 8.
60
The study authors summarised their findings by stating that their early mobilisation
group at 1.5 hours experienced significantly less back pain at the end of bed rest with a
mean score of 1.5 / 10 compared to their control group who mobilised at five hours and
had a mean back pain score of 3.5 / 10. The result was statistically significant at
p<0.001, favouring the early mobilisation group.
Chair et al. (2007) measured back pain at four hours, eight hours and the next morning.
The average back pain level at four hours in the experimental group who mobilised at
this four-hour time was 0.97, whereas the control group who remained in bed for 12
hours had an average pain level of 1.55 at four hours. At eight hours, when the
experimental group was mobilising and the control group still on bed rest, the results
were 1.34 vs. 4.41 respectively. In the morning, when they were both mobilising,
results were 1.77 experimental vs. 4.01 control. The result between the groups at all
three time frames were statistically significant at p < 0.001, favouring the early
mobilisation group.
Six studies didn’t directly measure back pain, but did mention back pain or pain. Baum
and Gantt (1996) reported that participants in their early mobilisation group of two
hours, who had previously had an angiogram and mobilised at six hours, gave positive
feedback citing less discomfort. The nurses involved in the study of Best et al. (2010)
noted fewer reports of patient discomfort in their early mobilisation group of one and a
half hours, as did the nurses in the study by Roebuck et al. (2000) whose experimental
group mobilised at two hours.
Roebuck et al. (2000) also pulled 100 charts (50 per group) in their study and looked at
intravenous pain relief use. The observations about increased comfort by the nurses
where reinforced by figures of 2% intravenous pain relief in the control group versus
none in the experimental group. The limitation of this observation, however, is that the
pain relief was not necessarily for back pain only.
Logemann et al. (1999) noted lower levels of overall pain and higher levels of overall
satisfaction in participants in their experimental group of mobilisation at two hours
taken from the Patient Satisfaction Questionnaire their participants completed. There
were similar findings in the study by Pollard et al (2003) who stated that at all times
measured on the McGill pain questionnaire, the 2.5 hour early mobilisation group
experienced less pain and discomfort. Nurses caring for patients in the study by Mah et
al. (1999), with their two and a half to three hour ambulation experimental group, noted
61
that patients made positive comments about comfort levels in early ambulation group,
experiencing less discomfort than the control group.
Sensitivity analysis
All 15 studies were deemed to be at a low risk of bias. However, as Best et al. (2010),
Mah et al. (1999), Roebuck et al. (2000) and Wang et al. (2001) used a quasi-
randomised or non-randomised study design, further analyses of the time frames with
these studies removed were undertaken. Leaving out these studies did not change the
outcomes at each time frame.
62
Table 3: Summary of Interventions in Early Mobilisation Trials
Study ID Sheath Sizes
Method of Achieving
Haemostasis
Total Bed rest
Experimental
Total Bed rest Control
Bed elevation during bed rest
(time after gaining haemostasis)
Baum 1996 5-8F Not mentioned 2 4 ?
Best 2010 5-6F Manual or C-clamp 1.5 3-4 To 30° at 45 minutes
Bogart 1999 8F Manual 4 6 ?
Chair 2007 5-6F Manual or C-clamp 4 12-24 ?
Farmanbar 2008 ≤7F Manual then sandbag 2 6 No
Hoglund 2011 ≤6F Femostop 1.5 5 ?
Keeling 1996 7-8F Manual 4 6 ?
Lim 1997 6F Femostop 4 6 To 45° immediately
Logemann 1999 6F Femostop 2 6 To 45° at 4 hours
Mah 1999 7F Manual 3 5 To ≥30° at 1 hour
Pollard 2003 6F Manual 2.5 4.5
To 60° at 1 hour in experimental group To 60° at 4 hours in control group
Roebuck 2000 6F Femostop 2 4 To 30° immediately
Singh 1998 3x6 7F Manual or C-clamp 3 6 ?
Wang 2001 5-6F Manual then sandbag
4 6 ?
Wood 1997 6F Manual or C-clamp
2.5 4 ?
63
Discussion
Summary of main results
Fifteen studies were identified that met the inclusion criteria for this Systematic Review.
Of the studies, six mobilised participants at or before two hours including a total of
1530 participants. Ten of the fifteen studies mobilised their participants at or before 3
hors, including a total of 3927 participants. All fifteen studies included mobilised their
participants at or prior to four hours, with a grand total of 4281 participants overall. All
of the studies included an experimental and a control group. In the case of Singh et al.
(1998) there were two experimental groups, one at three hours and one at four hours.
To reduce the chance of bias, only the results of the three-hour group and the six-hour
control group were included. All of the studies used vascular complications as their
measure of safety related to earlier mobilisation. These vascular complications
included haematoma (and retro-peritoneal haematoma), bleeding and pseudo-
aneurysm. All 15 studies were assessed as having a moderate quality as per the
GRADE Working Group grades of evidence (Schunemann et al., 2008). The
downgrading was either due to a quasi-randomised or non-randomised study design,
or incomplete allocation concealment or blinding.
Results have been summarised into time frames relating to the early mobilisation.
None of the six trials in the ≤ 2-hour group showed statistical significance between the
early mobilisation group and the control group with measured vascular complications.
Overall results favoured the control group but not with any statistical significance (RR
1.1591; 95% CI 0.7544-1.7809; p = 0.5023). The randomised controlled trials, when
analysed separately, showed similar figures favouring the control group but with no
statistical significance (RR 1.0746; 95% CI 0.6073-1.9012; p = 0.8763). Overall results
in the ≤ 3-hour favoured the experimental group, although the figures were not quite
statistically significant (RR 0.8430; 95% CI 0.7041-1.0094; p = 0.0625). When the
seven randomised controlled trials were analysed separately, figures slightly favoured
the control group but with no statistical significance (RR 1.0023; 95% CI 0.7818-
1.2849; p = 1.000). At the ≤ 4-hour timeframe, the overall vascular complication results
favoured the experimental group, although the figures were not quite statistically
significant (RR 0.8696; 95% CI 0.7399-1.0219; p = 0.0891). The eleven randomised
controlled trials in this timeframe slightly favoured the control group but with no
statistical significance (RR 1.0361; 95% CI 0.8440-1.2719; p = 0.7401).
64
Four studies directly measured back pain in both their experimental and control groups
to evaluate whether earlier mobilisation decreased levels of back pain experienced by
participants (Chair et al., 2007; Hoglund et al., 2011; Wang et al., 2001; Wood et al.,
1997). Three of the studies showed clear levels of decreased back pain in their
experimental groups, two of which showed a statistical significance (Hoglund et al.
2011 and Chair et al. 2007 both showing p < 0.001 favouring earlier mobilisation).
Wood et al. (1997) showed results that favoured the later mobilisation group, however,
their results may have been biased due to the inclusion of three participants with
chronic back pain who elevated the overall pain measurements due to their
experiencing 9 – 10 / 10 back pain on bed rest. Six others studies mentioned anecdotal
comments from participants, with more favourable comments from the experimental
groups relating to levels of back pain.
Overall completeness and applicability of evidence
Early mobilisation at or before four hours after a femoral approach coronary angiogram
has been well studied, with the fifteen studies found here. For fifteen years,
researchers have been looking at mobilisation at two, three and four hours and getting
favourable results towards earlier mobilisation where there is no statistically significant
increase in vascular complications with the early mobilisation out of bed. Although
several of the studies were relatively small, and on their own provide limited information,
when added into this systematic review they add valuable statistics.
One point noticeable in the review was the lower level of women in the studies. Chair
et al. (2007) was the only study to include similar levels of women to men in each of
their groups (55.8% women control / 48.8% women experimental). In several studies
looking at risk factors for vascular complication after coronary angiogram, it has been
found that females are more at risk of developing vascular complications such as
bleeding and haematoma than males (Dumont, Keeling, Bourguignon, Sarembock &
Turner, 2006; Eggebrecht et al., 2002; Gall, Tarique, Natarajan & Zaman, 2006; Gillane
& Pollard, 2009; Mah et al., 1999). Hoglund et al. (2011) reason that this could be due
to the smaller vasculature of females, which can lead to multiple punctures of the artery
and an increased chance of a haematoma. Although the studies included in this review
are representative of the presenting patient population for coronary angiogram,
perhaps more study could be undertaken specifically on women to ensure that the
results from these studies are replicable to that population.
65
Quality of the evidence
All 15 studies were assessed as having a moderate quality as per the GRADE Working
Group grades of evidence (Schunemann et al., 2008). Four of the studies (Best et al.,
2010; Mah et al., 1999; Roebuck et al., 2000; Wang et al., 2001) used a quasi-
randomised or non-randomised study design by either carrying out a week about
allocation or retrospective / prospective analysis, which may increase the bias in the
studies. Because of this, they were graded as moderate quality. None of the 11
included randomised controlled trials had complete allocation concealment or blinding,
which may increase bias. Although a randomised controlled trial is usually graded as a
High quality rating on the using the GRADE levels of evidence, these 11 studies were
downgraded due to their lack of concealment or blinding.
Authors’ conclusions
Implications for practice
This review aimed to provide an evidence-based argument that time to mobilisation can
be decreased in patients post-femoral approach diagnostic coronary angiogram
maintaining a low risk of vascular complications. This in turn would potentially help to
decrease or prevent back pain occurring. The results from this study show no
statistically significant difference in vascular complications between the control groups
and the early mobilisation out of bed groups at ≤2, 3 or 4 hours post femoral approach
coronary angiogram. Therefore, mobilisation after femoral approach coronary
angiogram, without deployment of a vascular closure device, may be as safe at 1 ½ to
4 hours mobilisation as it is at 6 hours and may have a positive benefit of reducing
back pain related to lying in bed.
Implications for research
As stated earlier, further research on early mobilisation post femoral approach coronary
angiogram on a higher number of female patients would be of benefit, due to their
under-representation in these fifteen studies.
It would also be beneficial if any further studies on this topic were randomised
controlled trials. This lowers the risk of bias and ensures they can be included in a
Systematic Review in the future.
66
Acknowledgements
We would like to thank Dalice A. Sim (PhD), Statistical Consultant from the School of
Mathematics, Statistics and Operation Research at Victoria University, for her
assistance with the statistical analysis in this Systematic Review and Meta-Analysis.
Declarations of interest
There is no potential conflict of interest among the review authors
Differences between protocol and review
In the protocol it was stated that included studies looked at coronary angioplasty as
well as diagnostic coronary angiogram. Only five studies were identified in the literature
search that included coronary angioplasty. These studies proved to be too heterogenic
in their methodology to be suitable for comparison in a Systematic Review. Therefore
the inclusion criteria for the Systematic Review included only studies that looked at
femoral approach diagnostic coronary angiogram.
References
References to studies included in this review
Baum, R. A., & Gantt, D. S. (1996). Safety of decreasing bedrest after coronary angiography. Catheterization and Cardiovascular Diagnosis, 39, 230-233.
Best, D. G., Pike, R., Grainger, P., Eastwood, C. A., & Carroll, K. (2010). A prospective
study of early ambulation 90 minutes post-left heart catheterization using a retrospective comparison group. Canadian Journal of Cardiovascular Nursing, 20(4), 15-20.
Bogart, M. A., Bogart, D. B., Rigden, L. B., Jung, S. C., & Liston, M. J. (1999). A
prospective randomised trial of early ambulation following 8 french diagnostic cardiac catheterization. Catheterization and Cardiovascular Interventions, 47, 175-178.
Chair, S. Y., Thompson, D. R., & Li, S. K. (2007). The effect of ambulation after cardiac
catheterization on patient outcomes. Journal of Clinical Nursing, 16, 212-214. Farmanbar, R., Chinikar, M., Gozalian, M., Baghaie, M., Roshan, Z. A., &
Moghadamnia, M. (2008). The effect of post coronary angiography bed-rest time on vascular complications. The Journal of Tehran University Health Center, 4, 225-228.
Hoglund, J., Stenestrand, U., Todt, T., & Johansson, I. (2011). The effect of early
mobilisation for patient undergoing coronary angiography; a pilot study with focus on vascular complications and back pain. European Journal of Cardiovascular Nursing, 10(2), 130-136.
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Keeling, A., Taylor, V., Nordt, L. A., Powers, E., & Fisher, C. (1996). Reducing time in bed after cardiac catheterization (TIBS II). American Journal of Critical Care, 5(4), 277-281.
Lim, R., Anderson, H., Walters, M. I., Kaye, G. C., Norell, M. S., & Caplin, J. L.
(1997). Femoral complications and bed rest duration after coronary arteriography. American Journal of Cardiology, 80, 222-223.
Logemann, T., Luetmer, P., Kaliebe, J., Olson, K., & Murdock, D. K. (1999). Two
versus six hours of bed rest following left-sided cardiac catheterization and a Meta-Analysis of early ambulation trials. American Journal of Cardiology, 84, 486-488.
Mah, J., Smith, H., & Jensen, L. (1999). Evaluation of 3-hour ambulation post
cardiac catheterization. Canadian Journal of Cardiovascular Nursing, 10(1-2), 23-30.
Pollard, S., Munks, K., Wales, C., Crossman, D., Cumberland, D., Oakley, G. &
Gunn, J. (2003). Position and Mobilisation Post Angiography Study (PAMPAS): a comparison of 4.5 hours and 2.5 hours bed rest. Heart, 89, 447-448.
Roebuck, A., Jessop, S., Turner, R., & Caplin, J. L. (2000). The safety of two-
hour versus four-hour bed rest after elective 6-french femoral cardiac catheterization. Coronary Health Care, 4, 169-173.
Singh, N., Kuganesan, K., Goode, E., & Ricci, A. J. (1998). The effect of early
ambulation on hematoma formation and vascular complications following 7 french diagnostic cardiac catheterization. Canadian Journal of Cardiology, 14(10), 1223-1227.
Wang, S., Redeker, N. S., Moreyra, A.E., & Diamond, M. R. (2001). Comparison
of comfort and local complications after cardiac catheterization. Clinical Nursing Research, 10(1), 29-39.
Wood, R. A., Lewis, B. K., Harber, D. R., Kovack, P. J., Bates, E. R., & Stomel,
R. J. (1997). Early ambulation following 6 french diagnostic left heart catheterization: a prospective randomized trial. Catheterization and Cardiovascular Diagnosis, 42, 8-10.
References to studies excluded from this review
Pooler-Lunse, C., Barkman, A., & Bock, B. F. (1996). Effects of modified positioning and mobilization on back pain and delayed bleeding in patients who had received heparin and undergone angiography: a pilot study. Heart & Lung, 25(2), 117-123.
Tagney, J., & Lackie, D. (2005). Bed-rest post-femoral arterial sheath removal – what is
safe practice? A clinical audit. Nursing in Critical Care, 10(4), 167-173. Tengiz, I., Ercan, E., Bozdemir, H., Durmaz, O., Gurgun, C., & Nalbantgil, I. (2003). Six
hour ambulation after elective coronary angioplasty and stenting with 7F guiding catheters and low dose heparin. Kardiology Polska, 58(2), 93-97.
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Additional references
Asinas, M. (2010). Coronary angiography: clinical information. Retrieved from http://www.joannabriggs.edu.au
Chair, S. Y. (2004). Effects of early ambulation after cardiac catheterization (Doctor of
Philosophy thesis, University of Colorado, United States of America). Retrieved from http://search.proquest.com/docview/305044512/1370BC6239A5C0586B5
/1?accountid=34374
Chair, S. Y., Li, K. M., & Wong, S. W. (2004). Factors that affect back pain among Hong Kong Chinese patients after cardiac catheterization. European Journal of Cardiovascular Nursing, 3(4), 279-285.
Chair, S. Y., Taylor-Piliae, R. E., Lam, G., & Chan, S. (2003). Effect of positioning on back pain after coronary angiography. Journal of Advanced Nursing, 42(5), 470-478.
Chandrasekar, B., Doucet, S., Bilodeau, L., Crepeau, J., deGuise, P., Gregoire,
J., . . . Pasternac, A. (2001). Complications of cardiac catheterization in the current era: a single-center experience. Catheterization and Cardiovascular Interventions, 52, 289-295.
Dumont, C., Keeling, A., Bourguignon, C., Sarembock, I., & Turner, M. (2006).
Predictors of vascular complications post diagnostic cardiac catheterization and percutaneous coronary interventions. Dimensions in Critical Care Nursing, 25(3), 137-142.
Eggebrecht, H., Haude, M., Woertgen, U., Schmermund, A., Von Birgelen, C.,
Naber, C., . . . Erbel, R. (2002). Systematic use of a collagen-based vascular closure device immediately after cardiac catheterization procedures in 1317 consecutive patients. Catheterization and Cardiovascular Interventions, 57, 486-495.
Gall, S., Tarique, A., Natarajan, A., & Zaman, A. (2006). Rapid ambulation after
coronary angiography via femoral artery access: A Prospective Study of 1,000 Patients. Journal of Invasive Cardiology, 18(3).
Gillane, O., & Pollard, M. (2009). Early ambulation of patients post-angiography
with femoral puncture. British Journal of Cardiology, 16, 137-140. Hay, D. (2004). Cardiovascular Disease in New Zealand. The National Heart
Foundation of New Zealand. Higgins, J. P. T., & Altman, D. G. (2008). Chapter 8: Assessing risk of bias in included
studies. In J.P.T. Higgins & S. Green (Eds.), Cochrane Handbook for Systematic Reviews of Interventions (pp. 359-387). Chichester, England: John Wiley & Sons.
Lauck, S., Johnson, J. L., & Ratner, P. A. (2005). Self-care behaviour and factors
associated with patient outcomes following same-day discharge percutaneous coronary intervention. European Journal of Cardiovascular Nursing, 8, 190-199.
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Ministry of Health. (2011). Provisional data: New Zealand mortality statistics: 2006 to 2009. Retrieved from http://www.health.govt.nz/publication/provisional-data-new-zealand-mortality-statistics-2006-2009
Rezaei-Adaryani, M., Ahmadi, F., & Asghari-Jafarabadi, M. (2009). The effect of
changing position and early ambulation after cardiac catheterization on patients' outcomes: A single-blind randomized controlled trial. International Journal of Nursing Studies, 46(8), 1047-1053.
Sabo, J., Chlan, L. L., & Savik, K. (2008). Relationships among patient characteristics,
comorbidities, and vascular complications post-percutaneous coronary intervention. Heart & Lung: The Journal of Acute and Critical Care, 37(3), 190-195.
Schunemann, H. J., Oxman, A. D., Vist, G. E., Higgins, J. P. T., Deeks, J. J., Glasziou,
P., & Guyatt, G. H. (2008). Chapter 12: Interpreting results and drawing conclusions. In J.P.T. Higgins & S. Green (Eds.), Cochrane Handbook for Systematic Reviews of Interventions (pp. 359-387). Chichester, England: John Wiley & Sons.
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ischaemic heart disease mortality in New Zealand to 2015. New Zealand Medical Journal, 119(1232), 14-26.
70
Characteristics of Studies
Table 4: Characteristics of Included Studies (ordered by study ID)
Baum and Gantt (1996)
Aim of Study To assess the safety of allowing patients to ambulate after 2 hours of bed rest following
diagnostic coronary angiography.
Methods Study design:
Duration:
Randomised Controlled Study
Not mentioned
Participants Country:
Setting:
Number participants:
Age:
Gender:
Inclusion criteria:
Exclusion criteria:
United States of America
Single centre, Cardiology Department
205 total; 104 control; 101 experimental
Mean control 59.0 years / Mean experimental 58.0 years
Not mentioned
Diagnostic coronary Angiogram
Femoral approach
5-8F Catheter
80% received 2500iu heparin
Age > 75 years of age
Severe aortic stenosis (aortic valve area < 1 cm
Creatinine >2.5 mg/dl
Full dose anticoagulation (oral or intravenously)
Unstable angina
Obesity >4 standard deviations
Severe aortic regurgitation
Left ventricular dysfunction (moist rales on examination, gallop
or elevated pulmonary capillary wedge pressure (PCWP) >20
mmHg)
Brachial artery approach
Interventions Experimental group:
Control group:
Follow-up:
Integrity of interventions:
2 hour bed rest period
Immediate ambulation in room
30 minutes - 200 feet
2 hours ambulation as desired
4 hour bed rest period
Immediate ambulation in room
30 minutes - 200 feet
2 hours ambulation as desired
Puncture site monitored through bed rest period
During ambulation in room then 30 minutes post ambulation
2 hours and 3 hours post ambulation
All participants received their allocated interventions
Outcomes Primary:
Bleeding
Haematoma
Risk of Bias Method of randomization:
Blinding:
Not mentioned
Not stated in study
71
Incomplete outcome data:
Outcome reporting:
Nil loss to follow up, all patients accounted for in data
Nil selective outcome reporting
Best et al. (2010)
Aim of Study To determine safety of ambulating patients at 90 minutes sheath removal compared to the
current practice of ambulation at three to four hours post-sheath removal.
Methods Study design:
Duration:
Retrospective vs. Prospective Quasi-Experimental Trial
6 months retrospective and then 6 months prospective
Participants Country:
Setting:
Number participants:
Age:
Gender:
Inclusion criteria:
Exclusion criteria:
Canada
Experimental single centre, Control all health centres in Alberta,
Canada via APPROACH database.
595 total; 402 control; 193 experimental
Mean control 62.1 years / Mean experimental 60.2 years
37.1% women control / 31.1% women experimental
Left heart diagnostic catheterisation
6F or less sheath
Over 19 years
Ability to ambulate post procedure
History of a bleeding disorder
Receiving anticoagulation by either the oral, intravenous or
subcutaneous route
Receiving IIb/IIIa platelet receptor inhibitors
Received thrombolytic therapy this admission
APTT greater than 38 seconds pre-procedure or platelets were
less than 130x109 /L pre-procedure
Prior femoral popliteal bypass
Percutaneous coronary intervention
Systolic BP >180mmHg or diastolic BP >110mmHg
Weight more than 350 pounds
Interventions Experimental group:
Control group:
Follow-up:
Integrity of interventions:
Immediate sheath removal
Manual compression or c-clamp
HOB elevation to 45° after 60 mins
90 minute ambulation
Immediate sheath removal
Manual compression or c-clamp
HOB elevation to 45° after 60 mins
3-4 hour ambulation
Not specifically mentioned
All participants received their allocated interventions
Outcomes Primary:
Bleeding was defined as access site bleed
Hematoma formation measured and categorized as <5cm, 5–
10cm or >10cm
AV fistula
72
Pseudoaneurysm
Retroperitoneal bleed
Vascular occlusion
Dissection
Risk of Bias Method of randomization:
Blinding:
Incomplete outcome data:
Outcome reporting:
Not applicable, retrospective control group, prospective
experimental group
Not applicable
Nil loss to follow up, all patients accounted for in data
Nil selective outcome reporting
Bogart et al. (1999)
Aim of Study To assess the safety of 4-hr ambulation after diagnostic cardiac catheterization with 8 French
sheaths and catheters.
Methods Study design:
Duration:
Randomised Controlled Trial
Not mentioned
Participants Country:
Setting:
Number participants:
Age:
Gender:
Inclusion criteria:
Exclusion criteria:
United States of America
Single centre, Cardiology Department
200 total; 100 control; 100 experimental
Mean control 60.0 years / Mean experimental 55.0 years
38.0% women control / 36.0% women experimental
Diagnostic cardiac catheterisation
Femoral approach
Geographic remoteness (more than 1h drive) from the laboratory
with inadequate or unreliable follow-up likely over the next 24 hr
An interventional therapeutic procedure
Transient cerebral ischemic episodes or recent stroke (less than
1 month before)
Severe systemic hypertension (systolic blood pressure greater
than 200 mm Hg and/or diastolic blood pressure greater than
100 mm Hg)
Severe peripheral vascular disease (femoral pulses 1 or less)
Age less than 21 years or greater than 75 years
Body surface area greater than 2.5 m2
Generalized debility or dementia
Frequent ventricular arrhythmias
Renal insufficiency (serum creatinine more than 2mg/dl)
Recent hospitalization for acute myocardial infarction (within past
7 days)
On intravenous heparin or with international normalized ratio
(INR) of >2
Chronic corticosteroid use
Non-compliance with the period of bed rest
Repeat procedure, same entry site within 1 week
Right heart catheterization
73
More than one arterial puncture to initiate the procedure
Thrombocytopenia (platelet count 100,000 mm3)
Interventions Experimental group:
Control group:
Follow-up:
Integrity of interventions:
Sheath removed when ACT less than 150
Mobilisation at 4 hours post sheath removal
Sheath removed when ACT less than 150
Mobilisation at 6 hours post sheath removal
The same researcher made a physical assessment of the groin
site upon ambulation and the following day in all patients.
Results documented at these times
All participants received their allocated interventions
Outcomes Primary:
Re-bleeding
Hematoma
Arterio-venous (AV) fistula
Pseudoaneurysm
Limb ischemia
Thrombosis of the femoral artery
Risk of Bias Method of randomization:
Blinding:
Incomplete outcome data:
Outcome reporting:
Not mentioned
Not stated in study
Nil loss to follow up, all patients accounted for in data
Nil selective outcome reporting
Chair et al. (2007)
Aim of Study The main purpose of this study was to determine the effects of an early ambulation
intervention after cardiac catheterization on patient's back pain and incidence of vascular
complications, especially bleeding and haematoma formation
Methods Study design:
Duration:
Randomised controlled trial
Not mentioned
Participants Country:
Setting:
Number participants:
Age:
Gender:
Inclusion criteria:
Exclusion criteria:
Hong Kong
Single centre study
86 total; 43 control; 43 experimental
Mean control 63.19 years / Mean experimental 62.70 years
55.8% women control / 48.8% women experimental
Coronary angiogram
Femoral approach
5-6F sheaths
Emergency cardiac catheterisation
Age <18 or >75 years old
Non-Chinese patients
Prior cardiac catheterisation
Known bleeding disorders
Anticoagulant therapy within 24 hours before procedure
Presence of back pain before procedure
74
Active bleeding from femoral site before sheath removal
Active bleeding from femoral site after sheath removal but before
ambulation
Medical complications such as angina and myocardial infarction
developed during the procedure
A systolic BP ≥ 180 mmHg and/or diastolic BP ≥ 110mmHg
before the procedure
Unable to ambulate independently before the procedure
Interventions Experimental group:
Control group:
Follow-up:
Integrity of interventions:
Sheath removed straight away
Mobilisation at 4 hours
Mobilised around bed for 2 minutes each hour for three hours
then mobilised freely
Sheath removed straight away
12-24 hours bed rest
Mobilised around bed for 2 minutes each hour for three hours
then mobilised freely
Puncture site checked regularly for first four hours then after
each period of ambulation
Back pain assessed at 4 hours, 8 hours and next morning
All participants received their allocated interventions
Outcomes Primary:
Secondary:
Haematoma
Bleeding
Back pain
Urinary discomfort
Puncture site pain
General well-being
Patient satisfaction
Risk of Bias Method of randomization:
Blinding:
Incomplete outcome data:
Outcome reporting:
Computer generated list
Not stated in study
Nil loss to follow up, all patients accounted for in data
Nil selective outcome reporting
Farmanbar et al. (2008)
Aim of Study To test the hypothesis that reducing time-to-ambulation from 6 hours to 2 hours would not
increase post-angiography vascular complications
Methods Study design:
Duration:
Randomised Controlled Trial
February 2006 to November 2006
Participants Country:
Setting:
Number participants:
Age:
Gender:
Iran
Post angiography wards in two different hospitals
120 total; 60 control; 60 experimental
Mean control 59.9 years / Mean experimental 60.17 years
41.7% women control / 38.3% women experimental
75
Inclusion criteria:
Exclusion criteria:
All patients of one interventionalist presenting for cardiac
angiography
Femoral approach
Single puncture of femoral artery mainly 7F sheath
Renal failure
Chronic obstructive pulmonary disease
Known pre-procedure bleeding disorder
Patient transfer to ICU post angiography
Interventions Experimental group:
Control group:
Follow-up:
Integrity of interventions:
Sheath removed immediately post procedure, then manual
compression of puncture site for minimum 10 minutes
Two 2.5kg sandbags placed, one removed at one hour the other
before mobilising
Mobilisation after 2 hours supine bed rest
Sheath removed immediately post procedure, then manual
compression of puncture site for minimum 10 minutes
Two 2.5kg sandbags placed, one removed at one hour the other
before mobilising
Mobilisation after 6 hours supine bed rest
Vital signs, pedal pulses and puncture site checked:
Prior to sheath removal
Every 15 minutes after haemostasis for 1 hour
Every 30 minutes for next hour
Every hour until ambulation
After ambulation every 15 minutes for 1 hour
Checked at discharge following day
All participants received their allocated interventions
Outcomes Primary:
Bleeding before ambulation
Small haematoma before ambulation (<5cmx5cm)
Large haematoma before ambulation (>5cmx5cm)
Post ambulation bleeding <24 hours
Post ambulation haematoma <24 hours
Late vascular complication (after 30 days)
Risk of Bias Method of randomization:
Blinding:
Incomplete outcome data:
Outcome reporting:
Not stated in study
Not stated in study
Nil loss to follow up, all patients accounted for in data
Nil selective outcome reporting
Hoglund et al. (2011)
Aim of Study To assess the safety, and perceived comfort, of early mobilisation after coronary angiography
with femoral approach in patients with dual antiplatelet therapy, comparing 1.5 and 5 hours of
bed rest
Methods Study design:
Duration:
Randomised controlled trial
January – June 2008
76
Participants Country:
Setting:
Number participants:
Age:
Gender:
Inclusion criteria:
Exclusion criteria:
Sweden
Single centre catheterisation lab
104 total; 52 control; 52 experimental
Mean control 65.1 years / Mean experimental 63.7 years
17.0% women control / 24.0% women experimental
≥ 18 years of age
Coronary Angiography for valvular disorder, stable angina,
NSTEMI or ACS
Aspirin and Clopidogrel loading and low molecular weight
heparin included
Not willing to participate
Participation in pharmacological study
Language difficulties
Sheath size >6 F
Pre-treatment with heparin and/or abciximab
Underwent angioplasty
Interventions Experimental group:
Control group:
Follow-up:
Integrity of interventions:
Sheath removed immediately after angiography and Femostop
placed
Pressure remained for 1 hours then additional 1/2 hour bed rest
Mobilised after total supine bed rest 1 1/2 hours
Sheath removed immediately after angiography and Femostop
placed
Pressure remained for 3 hours then additional 2 hours bed rest
Mobilised after total supine bed rest 5 hours
Immediately after angiography
1 hour in bed rest
After release of compression
At the end of bed rest
After 2 hours mobilisation
After 4 hours mobilisation
12-24 hours after procedure
Telephone interview 48-72 hours post procedure
All participants received their allocated interventions
Outcomes Primary:
Secondary:
Haematoma
Bleeding
Back pain
Risk of Bias Method of randomization:
Blinding:
Incomplete outcome data:
Outcome reporting:
Not stated in study
Not stated in study
Nil loss to follow up, all patients accounted for in data
Nil selective outcome reporting
Keeling et al. (1996)
Aim of Study To determine if there would be a significant difference in the incidence of bleeding from
femoral artery insertion sites between cardiac catheterization patients who remained in bed for
77
4 hours and those who remained in bed for 6 hours after sheath removal
Methods Study design:
Duration:
Randomised controlled trial
Not mentioned
Participants Country:
Setting:
Number participants:
Age:
Gender:
Inclusion criteria:
Exclusion criteria:
United States of America
Single centre acute cardiology unit
86 total; 43 control; 43 experimental
Mean control 58.0 years / Mean experimental 61.0 years
37.0% women control / 14.0% women experimental
Adults
Suspected or diagnosed coronary artery disease
Diagnostic cardiac catheterisation without PTCA
Femoral approach
Heparin or other anticoagulant or thrombolytic agents before the
procedure
Known bleeding disorders
Medical complications during the procedure
Those requiring admission post procedure
Interventions Experimental group:
Control group:
Follow-up:
Integrity of interventions:
Femoral artery sheath 7-8F
Immediate sheath removal with manual compression for average
20 mins
Sandbag placed (5lb) until mobilisation
Supine, leg straight, HOB allowed to 30°
Mobilised at 4 hours post sheath removal
As above but mobilised at 6 hours post sheath removal
After mobilisation and before discharge
All participants received their allocated interventions
Outcomes Primary:
Haematoma
Bleeding
Risk of Bias Method of randomization:
Blinding:
Incomplete outcome data:
Outcome reporting:
Not stated in study
Not stated in study
Nil loss to follow up, all patients accounted for in data
Nil selective outcome reporting
Lim et al. (1997)
Aim of Study To determine whether there is any difference in the femoral bleeding complication rate
between 4 and 6 hours of bed rest after elective coronary arteriography
Methods Study design:
Duration:
Randomised controlled trial
Not mentioned
Participants Country:
Setting:
United States of America
Single centre tertiary cardiology department
78
Number participants:
Age:
Gender:
Inclusion criteria:
Exclusion criteria:
200 total; 100 control; 100 experimental
Mean overall 59.0 years
% Women not mentioned
Left-sided diagnostic cardiac catheterization
Femoral approach
Peripheral vascular grafts
Interventions Experimental group:
Control group:
Follow-up:
Integrity of interventions:
Diagnostic angiogram via femoral approach
Immediate sheath removal
Femostop for 1 hour
Bed rest at 30-45° head up
Mobilised at 4 hours
As above then mobilised at 6 hours
From sheath removal to discharge
All participants received their allocated interventions
Outcomes Primary:
Bruising
Bleeding
Pseudoaneurysm
Blood transfusion
Need for surgical intervention
Risk of Bias Method of randomization:
Blinding:
Incomplete outcome data:
Outcome reporting:
Not stated in study
Operators only blinded from randomisation
Nil loss to follow up, all patients accounted for in data
Nil selective outcome reporting
Logemann et al. (1999)
Aim of Study This study compares the groin complication rate after cardiac catheterization in patients
treated with the standard 6-hour duration of bed rest with that after a duration of only 2 hours
Methods Study design:
Duration:
Randomised controlled trial
Not mentioned
Participants Country:
Setting:
Number participants:
Age:
Gender:
Inclusion criteria:
Exclusion criteria:
United States of America
Single centre regional heart centre
201 total; 96 control; 105 experimental
Mean control 62.0 years / Mean experimental 61.0 years
33.0% women control / 42.8% women experimental
Outpatient diagnostic cardiac catherisation
Femoral approach
Use of oral anticoagulants (except aspirin),
Age >80 years
Morbid obesity (>50% above ideal body weight)
History of bleeding disorder
Coronary disease detected at catheterization prompting
admission for treatment (coronary angioplasty or surgery)
79
Creatinine 2.0 mg/dl
Severe aortic valvular disease
Severe hypertension (systolic blood pressure >180 mm Hg or
diastolic blood pressure >105 mm Hg)
Interventions Experimental group:
Control group:
Follow-up:
Integrity of interventions:
6F diagnostic femoral cardiac angiogram
Immediate sheath removal
Femostop pressure device for 30 minutes
Supine bed rest
Mobilised at 2 hours
Observed for 5 hours then discharged
As above except head of bed elevated at 4 hours to 45°
Mobilised at 6 hours
Discharged 1 hour after that
Observed from sheath removal until discharge 7 hours
afterwards
All participants received their allocated interventions
Outcomes Primary:
Bleeding
Haematoma
Pseudoaneurysm
Vascular repair
Blood transfusion
Risk of Bias Method of randomization:
Blinding:
Incomplete outcome data:
Outcome reporting:
Not stated in study
Not stated in study
Nil loss to follow up, all patients accounted for in data
Nil selective outcome reporting
Mah et al. (1999)
Aim of Study To evaluate the effects of 3-hour ambulation post cardiac catheterization with a 7 french
arterial catheter on bleeding, haematoma formation and vascular complications
Methods Study design:
Duration:
Retrospective / prospective controlled trial
Retrospective 8 months from start point for control group then
forward 7 months for experimental 3 hour group
80
Participants Country:
Setting:
Number participants:
Age:
Gender:
Inclusion criteria:
Exclusion criteria:
Canada
Single centre large tertiary hospital
880 total; 472 control; 408 experimental
Mean control 61.55 years / Mean experimental 60.82 years
22.0% women control / 22.4% women experimental
All patients who underwent an elective diagnostic left heart
catheterization
Femoral access
Aortic and/or mitral stenosis, regurgitation or insufficiency
Full anticoagulation
Systolic BP >180mmHg and/or diastolic >110mmHg
PT INR > 2.2 if on Coumadin
Obesity: BMI >30
Catheterization via brachial artery
Use of Angio-seal
Interventions Experimental group:
Control group:
Follow-up:
Integrity of interventions:
7F sheath, removed immediately
Minimum of 10 mins manual pressure
Supine for 1 hour
Then could lie on either side with HOB >30% as long as effected
leg straight
Mobilised at 3 hours
As above but mobilised at 5 hours
From sheath removal to discharge
All participants received their allocated interventions
Outcomes Primary:
Bleeding
Haematoma
AV fistula
Pseudoaneurysm
Thrombosis
Risk of Bias Method of randomization:
Blinding:
Incomplete outcome data:
Outcome reporting:
Not applicable, retrospective control group, prospective
experimental group
Not applicable
Nil loss to follow up, all patients accounted for in data
Nil selective outcome reporting
Pollard et al. (2003)
Aim of Study To examine the safety of early sit-up and mobilisation after routine cardiac catheterisation in
contemporary practice
Methods Study design:
Duration:
Randomised controlled trial
Not mentioned
Participants Country:
Setting:
United Kingdom
Single centre
81
Number participants:
Age:
Gender:
Inclusion criteria:
Exclusion criteria:
705 total; 362 control; 343 experimental
Not mentioned
Not mentioned
Presence of stable angina
Planned, elective diagnostic catheterisation
Successful single puncture of femoral artery
6F catheter
Age <18 years
Inability to give informed consent
Possible pregnancy
Participation in another study
Coronary angioplasty at same sitting
Heparin treatment
Warfarin with INR ≥2.0
Bleeding disorder
Previous surgery to iliac or femoral arteries
Right heart catheter performed at same sitting
Interventions Experimental group:
Control group:
Follow-up:
Integrity of interventions:
Sheath removed immediately with minimum of 10 minutes
manual compression
Supine then sit up after 1 hour
Mobilise after 2.5 hours
Sheath removed immediately with minimum of 10 minutes
manual compression
Supine then sit up after 4 hours
Mobilise after 4.5 hours
Levels of comfort and groin site
Pre procedure
30 minutes post
2 hours post
4 hours post
48 hours post
All participants received the allocated intervention
Outcomes Primary:
Secondary:
Bleeding
Haematoma
False Aneurysm
Transfusion
Surgical repair
Level of discomfort as per McGill Pain Questionnaire
Risk of Bias Method of randomization:
Blinding:
Incomplete outcome data:
Outcome reporting:
Not stated in study
None – open label
Nil loss to follow up, all patients accounted for in data
Nil selective outcome reporting except 50 patients withdrew from
study and not explained why
82
Roebuck et al. (2000)
Aim of Study The trial examined the safety of reducing bed rest from 4 h. to 2 h. after elective 6-French
cardiac catheterisation.
Methods Study design:
Duration:
Quasi-experimental controlled trial, week about allocation
Not mentioned
Participants Country:
Setting:
Number participants:
Age:
Gender:
Inclusion criteria:
Exclusion criteria:
United Kingdom
Single centre cardiothoracic referral centre
305 total; 117 control; 188 experimental
Mean control 61.0 years / Mean experimental 60.0 years
27.0% women control / 31.0% women experimental
Elective patients
6F femoral approach diagnostic cardiac catheterization
INR >1.5
Interventions Experimental group:
Control group:
Follow-up:
Integrity of interventions:
Diagnostic angiogram with 6F sheath
Immediate sheath removal then Femostop placement for 1 hour
Once Femostop off, back of bed elevated to 30°
Mobilised at 2 hours if no haematoma or bleeding
As above except mobilised at 4 hours
Hourly for first four hours, telephone follow up at 24 hours then
at one month
All participants received the allocated intervention
Outcomes Primary:
Haematoma
Bleeding
Transfusion requirement
Pseudoaneurysm
Risk of Bias Method of randomization:
Blinding:
Incomplete outcome data:
Outcome reporting:
Week about allocation to each group
Not stated in study
Nil loss to follow up, all patients accounted for in data
Nil selective outcome reporting
Singh et al. (1998)
Aim of Study To assess the feasibility and safety of early ambulation 3 to 4 hours after diagnostic cardiac
catheterization
Methods Study design:
Duration:
Randomised controlled trial
April 1996 – August 1997
Participants Country:
Setting:
Number participants:
Age:
Canada
Single centre - tertiary care urban community hospital
874 total; 185 control; 336 experimental 1; 353 experimental 2
Mean overall 60.0 years
83
Gender:
Inclusion criteria:
Exclusion criteria:
29.0% women overall
7 french diagnostic cardiac angiogram
Femoral approach
Refused consent
Cardiologist refused
Patient involved in another study that could affect bleeding risk
Interventions Experimental group 1:
Experimental group 2:
Control group:
Follow-up:
Integrity of interventions:
7F femoral approach cardiac catheter
Sheath removed immediately
Manual compression or C clamp
Mobilised at 3 hours
As above then mobilised at 4 hours
As above then mobilised at 6 hours
Assessed after sheath removal and throughout stay until
discharge
Follow up phone call 24 hours after discharge
All participants received the allocated intervention
Outcomes Primary:
Haematoma
Blood transfusion requirement
Need for vascular repair
Thromboembolism
Local Infection
Pseudoaneurysm formation
Risk of Bias Method of randomization:
Blinding:
Incomplete outcome data:
Outcome reporting:
Not mentioned
Not mentioned
Nil loss to follow up, all patients accounted for in data
Nil selective outcome reporting
Wang et al. (2001)
Aim of Study The following hypotheses were addressed: Patients who receive 4 versus 6 hours of bed rest
after left-heart catheterization will report no difference in the occurrence of hematoma or active
bleeding or loss of distal pulses due to clot formation at the puncture site, less back pain or
puncture-site pain, less numbness and tingling sensation in the procedure limb, and higher
satisfaction with the procedure care or time on bed rest
Methods Study design:
Duration:
Quasi-experimental controlled trial
Not mentioned
Participants Country:
Setting:
Number participants:
Age:
Gender:
Inclusion criteria:
United States of America
Single centre cardiology outpatient unit
82 total; 41 control; 41 experimental
Mean control 62.0 years / Mean experimental 58.7 years
26.8% women control / 34.0% women experimental
Admitted for left-heart catheterization
Able to speak English
84
Exclusion criteria:
Willing to participate in the study as evidenced by a signed
written consent
Had serum potassium level less than 5.5mEq/,
Serum prothrombin time (PT) level less than 15 sec
Blood hemoglobin level greater than 8.5gm/dL at preadmission
testing
Unstable angina during or after the procedure
Severe peripheral vascular disease
Hematoma immediately after catheterization in the
catheterization laboratory
Need for heparin bolus during or after the procedure
Requirement for right and left-heart catheterization
Pressure dressing to site post-procedure
Overnight stay
Pressure dressing required
Interventions Experimental group:
Control group:
Follow-up:
Integrity of interventions:
Femoral approach
5-6F sheaths
Sheaths removed immediately then manual pressure applied
Once haemostasis, 12 pound sandbag applied
Supine for 2 hours
Bed raised to 45°
Mobilised after 4 hours
As above but mobilised after 6 hours
Every 15 minutes for the 1st hour
Every 30 minutes for 2 hours
Every hour until discharge
Numeric Rating Scale questionnaires given before mobilisation
All participants received the allocated intervention
Outcomes Primary:
Secondary:
Bleeding
Haematoma
Back pain
Risk of Bias Method of randomization:
Blinding:
Incomplete outcome data:
Outcome reporting:
No randomisation, week about into control or experimental group
Not mentioned
Nil loss to follow up, all patients accounted for in data
Nil selective outcome reporting
Wood et al. (1997)
Aim of Study Early Ambulation Following 6 French Diagnostic Left Heart Catheterization comparing 2.5 and
4 hours
Methods Study design:
Duration:
Randomised controlled trial
Not mentioned
Participants Country: United States of America
85
Setting:
Number participants:
Age:
Gender:
Inclusion criteria:
Exclusion criteria:
Single centre community hospital
291 total; 167 control; 124 experimental
Mean control 60.8 years / Mean experimental 60.0 years
40.4% women control / 40.7% women experimental
Diagnostic coronary angiogram
Femoral approach with 6F sheath
Aspirin ok
Warfarin stopped 3 days prior
Outpatients
PTCA
Admission for CABG
Bleeding or haematoma prior to ambulation
Interventions Experimental group:
Control group:
Follow-up:
Integrity of interventions:
6F femoral sheath
Immediate sheath removal
Manual compression or C-clamp for minimum of 12 minutes
Patient mobilised at 2.5 hours
As above except mobilised at 4 hours
Immediately after ambulation patients assessed for haematoma,
bleeding and level of comfort whilst they had been in bed.
Follow up phone call within 48 hours of discharge
All participants received the allocated intervention
Outcomes Primary:
Secondary:
Haematoma
Bleeding
Pseudoaneurysm
Presence of back pain or leg stiffness
Risk of Bias Method of randomization:
Blinding:
Incomplete outcome data:
Outcome reporting:
Dice throw, (1,2,3 mobilised at 2.5 hours, 4,5,6 mobilised at 4
hours)
Not mentioned
Nil loss to follow up, all patients accounted for in data
Nil selective outcome reporting
86
Table 5: Characteristics of excluded studies
Study Reason for exclusion
Pooler-Lunse, Barkman &
Bock (1996)
This study looked mainly at modified positioning prior to mobilisation and has been
included the previous discussion on this topic. However, although it also discusses early
mobilisation, in this study that meant just standing beside the bed for two minutes and
not walking around the unit (as with all of the other early mobilisation studies). Therefore
it was excluded from the early mobilisation review.
Tagney and Lackie (2005) This study looked at both diagnostic angiogram and angioplasty. One third of participants
received a vascular closure device. The results were not displayed in such a way as to
ascertain only the vascular complications related to those who did not receive a vascular
closure device, nor did they differentiate between angiogram and angioplasty results.
Therefore, the study was not included in the review.
Tengiz et al. (2003) Despite an extensive search, including emailing the magazine itself and searching 3
different libraries, the full-text article of this study was not able to be located. Therefore it
could not be included in the review.
87
Data and analysis
Table 6: ≤ 2 hours bed rest post-diagnostic coronary angiogram - total bleeding complications (bleeding / haematoma)
Study ID Numbers (Experimental/Control)
Hours Bed rest (Experimental/Control)
Total Number Bleeding Complications (Experimental/Control)
Risk Ratio (95% CI) P-value
Baum 1996 101 / 104 2 / 4 5 / 3 1.7162 (0.4211-6.9939) 0.4938
Farmanbar 2008 60 / 60 2 / 6 1 / 2 0.5000 (0.0466-5.3684) 1
Hoglund 2011 52 / 52 1.5 / 5 8 / 5 1.6000 (0.5604-4.5685) 0.5547
Logemann 1999 105 / 96 2 / 6 9 / 10 0.8229 (0.3493-1.9387) 0.8100
Total RCT’s 318 / 312 1-2 / 3-6 23 / 20 1.1283 (0.6327-2.0123) 0.7529
Best 2010 193 / 402 1.5 / 3-4 6 / 12 1.0415 (0.3968-2.7332) 1
Roebuck 2000 188 / 117 2 / 4 10 / 7 0.8891 (0.3480-2.2712) 1
Total Non-RCTs 381 / 519 16 / 19 1.1471 (0.5978-2.2012) 0.7286
Total All 699 / 831 1-2 / 3-6 39 / 39 1.1888 (0.7716-1.8318) 0.4310
88
Table 7: ≤ 2 hours bed rest post-diagnostic coronary angiogram - total vascular complications (total bleeding / pseudoaneurysm)
Study ID Numbers (Experimental/Control)
Hours Bed rest (Experimental/Control)
Total Number Vascular Complications (Experimental/Control)
Risk Ratio (95% CI) P-value
Baum 1996 101 / 104 2 / 4 5 / 3 1.7162 (0.4211-6.9939) 0.4938
Farmanbar 2008 60 / 60 2 / 6 1 / 2 0.5000 (0.0466-5.3684) 1
Hoglund 2011 52 / 52 1.5 / 5 8 / 6 1.3333 (0.4973-3.5749) 0.7749
Logemann 1999 105 / 96 2 / 6 9 / 10 0.8229 (0.3493-1.9387) 0.8100
Total RCT’s 318 / 312 23 / 21 1.0746 (0.6073-1.9012) 0.8763
Best 2010 193 / 402 1.5 / 3-4 6 / 12 1.0415 (0.3968-2.7332) 1
Roebuck 2000 188 / 117 2 / 4 10 / 7 0.8891 (0.3480-2.2712) 1
Total Non-RCT’s 381 / 519 16 / 19 1.1471 (0.5978-2.2012) 0.7286
Total All 699 / 831 39 / 40 1.1591 (0.7544-1.7809) 0.5023
89
Table 8: ≤ 3 hours bed rest post-diagnostic coronary angiogram - total bleeding complications (bleeding / haematoma)
Study ID Numbers (Experimental/Control)
Hours Bed rest (Experimental/Control)
Total Number Bleeding Complications (Experimental/Control)
Risk Ratio (95% CI) P-value
Baum 1996 101 / 104 2 / 4 5 / 3 1.7162 (0.4211-6.9939) 0.4938
Farmanbar 2008 60 / 60 2 / 6 1 / 2 0.5000 (0.0466-5.3684) 1
Hoglund 2011 52 / 52 1.5 / 5 8 / 5 1.6000 (0.5604-4.5685) 0.5547
Logemann 1999 105 / 96 2 / 6 9 / 10 0.8229 (0.3493-1.9387) 0.8100
Pollard 2003 343 / 362 2.5 / 4.5 69/55 1.324 (0.9595-1.8271) 0.0929
Singh 1998 336 / 185 3 / 6 21 / 12 0.9635 (0.4851-1.9137) 1
Wood 1997 124 / 167 2.5 / 4 7 / 13 0.7252 (0.2981-1.7642) 0.4961
Total RCT’s 1191 / 1026 120 / 100 1.0338 (0.8036-1.3299) 0.7913
Best 2010 193 / 402 1.5 / 3-4 6 / 12 1.0415 (0.3968-2.7332) 1
Mah 1999 408 / 472 3 / 5 53 / 115 0.5332 (0.3961-0.7177) 0.00002
Roebuck 2000 188 / 117 2 / 4 10 / 7 0.8891 (0.3480-2.2712) 1
Total Non-RCT’s 789 / 991 69 / 134 0.6468 (0.4913-0.8514) 0.0016
Total All 1910 / 2017 189 / 234 0.8529 (0.7116-1.0224) 0.0848
90
Table 9: ≤ 3 hours bed rest post-diagnostic coronary angiogram - total vascular complications (total bleeding / pseudoaneurysm)
Study ID Numbers (Experimental/Control)
Hours Bed rest (Experimental/Control)
Total Number Vascular Complications (Experimental/Control)
Risk Ratio (95% CI) P-value
Baum 1996 101 / 104 2 / 4 5 / 3 1.7162 (0.4211-6.9939) 0.4938
Farmanbar 2008 60 / 60 2 / 6 1 / 2 0.5000 (0.0466-5.3684) 1
Hoglund 2011 52 / 52 1.5 / 5 8 / 6 1.3333 (0.4973-3.5749) 0.7749
Logemann 1999 105 / 96 2 / 6 9 / 10 0.8229 (0.3493-1.9387) 0.8100
Pollard 2003 343 / 362 2.5 / 4.5 70 / 56 1.3192 (0.9591-1.8147) 0.0949
Singh 1998 336 / 185 3 / 6 21 / 13 0.8894 (0.4560-1.7347) 0.8532
Wood 1997 124 / 167 2.5 / 4 7 / 14 0.6734 (0.2801-1.6187) 0.4933
Total RCT’s 1191 / 1026 121 / 104 1.0023 (0.7818-1.2849) 1
Best 2010 193 / 402 1.5 / 3-4 6 / 12 1.0415 (0.3968-2.7332) 1
Mah 1999 408 / 472 3 / 5 53 / 115 0.5332 (0.3961-0.7177) 0.00002
Roebuck 2000 188 / 117 2 / 4 10 / 7 0.8891 (0.3480-2.2712) 1
Total Non-RCT’s 789 / 991 69 / 134 0.6468 (0.4913-0.8514) 0.0016
Total All 1910 / 2017 190 / 238 0.8430 (0.7041-1.0094) 0.0625
91
Table 10: ≤ 4 hours bed rest post-diagnostic coronary angiogram - total bleeding complications (bleeding / haematoma)
Study ID Numbers (Experimental/Control)
Hours Bed rest (Experimental/Control)
Total Number Bleeding Complications (Experimental/Control)
Risk Ratio (95% CI) P-value
Baum 1996 101 / 104 2 / 4 5 / 3 1.7162 (0.4211-6.9939) 0.4938
Bogart 1999 100 / 100 4 / 6 1 / 2 0.5 (0.0461-5.4265) 1
Chair 2007 43 / 43 4 / 12-24 0 / 1 0 (0-Not Defined) 1
Farmanbar 2008 60 / 60 2 / 6 1 / 2 0.5000 (0.0466-5.3684) 1
Hoglund 2011 52 / 52 1.5 / 5 8 / 5 1.6000 (0.5604-4.5685) 0.5547
Keeling 1996 43 / 43 4 / 6 1 / 0 Infinity (Not Defined -Infinity) 1
Logemann 1999 105 / 96 2 / 6 9 / 10 0.8229 (0.3493-1.9387) 0.8100
Lim 1997 100 / 100 4 / 6 47 / 44 1.0682 (0.7884-1.4472) 0.7765
Pollard 2003 343 / 362 2.5 / 4.5 69/55 1.324 (0.9595-1.8271) 0.0929
Singh 1998 336 / 185 3 / 6 21 / 12 0.9635 (0.4851-1.9137) 1
Wood 1997 124 / 167 2.5 / 4 7 / 13 0.7252 (0.2981-1.7642) 0.4961
Total RCT’s 1407 / 1312 139 / 147 0.8817 (0.7081-1.098) 0.2598
Best 2010 193 / 402 1.5 / 3-4 6 / 12 1.0415 (0.3968-2.7332) 1
Mah 1999 408 / 472 3 / 5 53 / 115 0.5332 (0.3961-0.7177) 0.00002
Roebuck 2000 188 / 117 2 / 4 10 / 7 0.8891 (0.3480-2.2712) 1
Wang 2001 41 / 41 4 / 6 0 / 1 0 (0- Not Defined) 1
Total Non-RCT’s 830 / 1032 69 / 135 0.6355 (0.4826-0.8369) 0.0011
Total All 2237 / 2344 238 / 282 0.8843 (0.7517-1.0404) 0.1380
92
Table 11: ≤ 4 hours bed rest post-diagnostic coronary angiogram – total vascular complications (total bleeding / pseudoaneurysm)
Study ID Numbers (Experimental/Control)
Hours Bed rest (Experimental/Control)
Total Number Vascular Complications (Experimental/Control)
Risk Ratio (95% CI) P-value
Baum 1996 101 / 104 2 / 4 5 / 3 1.7162 (0.4211-6.9939) 0.4938
Bogart 1999 100 / 100 4 / 6 1 / 3 0.3333 (0.0353-3.1505) 0.6212
Chair 2007 43 / 43 4 / 12-24 0 / 1 0 (0- Not Defined) 1
Farmanbar 2008 60 / 60 2 / 6 1 / 2 0.5000 (0.0466-5.3684) 1
Hoglund 2011 52 / 52 1.5 / 5 8 / 6 1.3333 (0.4973-3.5749) 0.7749
Keeling 1996 43 / 43 4 / 6 1 / 0 Infinity (Not Defined -Infinity) 1
Logemann 1999 105 / 96 2 / 6 9 / 10 0.8229 (0.3493-1.9387) 0.8100
Lim 1997 100 / 100 4 / 6 47 / 45 1.0444 (0.7734-1.4105) 0.8872
Pollard 2003 343 / 362 2.5 / 4.5 70 / 56 1.3192 (0.9591-1.8147) 0.0949
Singh 1998 336 / 185 3 / 6 21 / 13 0.8894 (0.4560-1.7347) 0.8532
Wood 1997 124 / 167 2.5 / 4 7 / 14 0.6734 (0.2801-1.6187) 0.4933
Total RCT’s 1407 / 1312 170 / 153 1.0361 (0.8440-1.2719) 0.7401
Best 2010 193 / 402 1.5 / 3-4 6 / 12 1.0415 (0.3968-2.7332) 1
Mah 1999 408 / 472 3 / 5 53 / 115 0.5332 (0.3961-0.7177) 0.00002
Roebuck 2000 188 / 117 2 / 4 10 / 7 0.8891 (0.3480-2.2712) 1
Wang 2001 41 / 41 4 / 6 0 / 1 0 (0- Not Defined) 1
Total Non-RCT’s 830 / 1032 69 / 135 0.6355 (0.4826-0.8369) 0.0011
Total All 2237 / 2344 239 / 288 0.8696 (0.7399-1.0219) 0.0891
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Table 12: Results – Randomised Controlled Trials Only
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Table 13: Results – All Included studies
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Appendices
Appendix I. Flowchart for inclusion / exclusion of studies
Databases searched for relevant articles • Wiley InterScience (69 articles) • CINAHL (85 articles) • PubMed includes MEDLINE (94 articles) • Proquest Central (463 articles) • Science Direct (18 articles) • Cochrane Database of Systematic
Reviews (0 found)
Articles excluded after reading title and abstract of the articles (709 articles)
Full text articles sought for more detailed evaluation (18 articles)
Studies excluded from full text articles (3 articles)
Articles included in Systematic Review (15 articles)
Figure 1.
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Appendix II. Search strategies
CINAHL, Science Direct, Proquest Central
(coronary OR cardiac) AND (angiogra* OR catheteri*) AND (back pain OR mobili* OR
discomfort OR ambulation)
Limits: in abstract or title; published 1996 – 2012; English
PubMed (includes MEDLINE)
1. clinical trial(Publication Type)
2. english(Language)
3. coronary(Title/Abstract)
4. cardiac(Title/Abstract)
5. (mobilisation(Title/Abstract)) OR mobilization(Title/Abstract)
6. ambulation(Title/Abstract)
7. "back pain"(Title/Abstract)
8. discomfort(Title/Abstract)
9. position*(Title/Abstract)
10. angiogram(Title/Abstract)
11. catheterisation(Title/Abstract) OR catheterization(Title/Abstract)
12. (#3 OR #4) AND #1
13. (#5 OR #6 OR #9) AND #1
14. (#7 OR #8) AND #1
15. (#10 OR #11) AND #1
16. #12 AND #15
17. #16 AND #14
18. #16 AND #13
19. #17 AND #18
20. #19 AND #2
21. #19 NOT #2
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Appendix III. Criteria and definitions for risk of bias assessment
The Cochrane Collaboration’s tool for assessing bias (Higgins & Altman, 2008) was
used as the base for assessing bias in the studies includes in this review. A ‘Yes’
indicates a low risk of bias and a ‘No’ indicates a high risk of bias.
1. Was the allocation sequence randomly generated?
Does the study reveal how the participants were allocated to each group in the
trial? If a recognised randomisation method such as computer randomisation, dice
roll or coin toss was used, the study scored a ‘Yes’. If the authors declared that the
method was not randomised, such as a retrospective / prospective trial, the study
scored a ‘No’. If it was unclear as to whether the method was randomised or not
stated, the study scored as ‘Unclear’.
2. Was allocation adequately concealed from both participants and clinicians by
having a secure schedule of randomization?
Did anybody involved in the treatment of the participant have any idea of which
group the patient was to be randomised into before randomisation took place? If
concealment from randomisation took place, the study scored a ‘Yes’. If the study
stated that the allocation was known prior, the study scored a ‘No’. If it was not
mentioned or unclear, then the study was scored as ‘Unclear’.
3. Were participants, clinicians and outcome assessors blinded to the allocated
intervention adequately during the study?
To score a ‘Yes’, all of the participants, clinicians and outcome assessors had to be
blinded to the allocated intervention group. If only one or two were blinded then the
study scored a ‘No’. If it was unclear or not mentioned, the study scored as
‘Unclear’.
4. Are results reported for everyone who entered the trial?
Do the numbers given in the results equal the numbers of participants who entered
the trial? If they do, the study scores a ‘Yes’. If not, the study scores a ‘No’. If
unclear the study scored as ‘Unclear’.
5. Was incomplete outcome data adequately addressed?
Did the study mention all participants who left the trial and reasons for why they
left? Were their results presented alongside those who did have full data acquired?
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If they did, the study scored a ‘Yes’. If there was data missing, the study scored a
‘No’. If unclear the study scored as ‘Unclear’.
6. Were patients analysed in the groups to which they were randomised?
Did the participants stay in the same groups that they were first randomised? If they
did, the study scored a ‘Yes’. If participants switched groups, the study scored a
‘No’. If it was unclear whether they stayed in the same group, the study scored as
‘Unclear’.
7. Are reports of the study free of selective outcome reporting?
Did the study provide all of the outcomes that they stated they would in the study
methodology? Was the same weight applied to all outcomes despite them being
positive or negative? If they were, then the study scored a ‘Yes’. If they were not,
the study scored a ‘No’. If it was unclear, the study scored as ‘Unclear’.
8. Was the study apparently free of other problems that could put it at a high risk of
bias?
Could any other sources of bias be ascertained from analyzing the study? If the
study was free of any further bias, it scored a ‘Yes’. If there was other bias
assessed, the study scored a ‘No’. If it was unclear about any matter mentioned in
the study that could lead to bias, the study was assessed as ‘Unclear’.
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Appendix IV. Systematic Review Protocol
Early mobilisation after femoral approach diagnostic coronary angiography or angioplasty to reduce back pain
Kelly L. Burn1, Bob Marshall2, Gill Scrymgeour2
1Interventional Cardiology, Capital and Coast Health District Health Board, Wellington,
New Zealand
2Eastern Institute of Technology, Taradale, Napier, Hawke’s Bay, New Zealand
Contact address: Kelly Burn, Interventional Cardiology, Wellington Hospital, Riddiford
Street, Newtown, Wellington, New Zealand. kelly.burn@ccdhb.org.nz
Background
Coronary heart disease remains the leading cause of death in New Zealand at 22%,
with rates of disease in Maori and Pacific people over twice the rate of other New
Zealanders. It accounts for over 25,000 inpatient admissions and nearly 4,000 day-
case admissions in New Zealand per year (Hay, 2004). Cardiac catheterization is a
common procedure undertaken to assess for and treat coronary heart disease (Chair,
Li & Wong, 2004).
Coronary angiography and angioplasty / stenting is most commonly carried out via a
5F – 7F arterial sheath inserted into the patient’s femoral artery. Through this sheath,
interventional devices such as catheters, wires, balloons and stents are passed. To
prevent acute thrombosis in the coronary vessels, the patient may be administered
anticoagulation medication such as heparin. The femoral sheath is commonly removed
4-6 hours post-procedure and then the patient remains on bed rest for a further 4-6
hours (Sabo, Chlan & Savik, 2008) to reduce the chances of bleeding from the groin
site (Chair, Taylor-Piliae, Lam & Chan, 2003).
Due to this enforced supine bed rest, immobilization and restricted positioning,
patients’ frequently experience back pain (Chair et al., 2003). Prolonged bed rest
causes pressure to be exerted continuously onto the same back muscles, causing
muscle fatigue and weakness. This fatigue causes back pain due to back spasms
(Chair et al., 2004). Studies have shown that bed rest and positioning regimes are
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based on tradition rather than research (Rezaei-Adaryani, Ahmadi & Asghari-
Jafarabadi, 2009). The aim of this systematic review is to ascertain the earliest time a
patient can mobilise after angiography to minimize or prevent this back pain, whilst
keeping the risk of vascular complications low.
The purpose of the systematic review is to collate quasi-randomised controlled trials,
non randomised controlled trials and randomized controlled trials looking at early
mobilisation to reduce back pain in patients who have a femoral artery approach
coronary angiogram or angioplasty. There is no Cochrane Collaboration systematic
review on this topic.
Objectives
The aim of this Systematic Review and Meta-Analysis to ascertain whether it is safe for
nurses to mobilise patients out of bed four hours or earlier after a femoral approach
coronary angiogram without the use of a vascular closure device, in order to reduce
back pain whilst not increasing the risk of vascular complications at the puncture site.
Methods
Types of studies
Both randomised and quasi-randomised trials, which contain a control group and at
least one experimental group, will be included. Studies with a qualitative methodology
or those that do not contain a control group will not be included. They must be
published in the last 15 years and be in English.
Types of participants and interventions
Studies that include adult patients over 18 years, both male and female, will be
included. The participants must have undergone a femoral approach coronary
angiogram or angioplasty.
Types of outcome measures
Studies that will be included in the review will have primary outcome measures of
vascular complications including bleeding, haematoma (including retroperitoneal
haematoma) and pseudo-aneurysm. It would also be preferable if the studies
measured as secondary outcomes levels of back pain, discomfort and satisfaction.
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Search Methods
Databases that will be searched for studies will include CINAHL, PubMed, Proquest
and the Cochrane Database. Reference lists of already acquired research will also be
searched for studies. Search terms that will be used include (coronary OR cardiac)
AND (angio* OR catheteri*) AND (back pain OR position* OR mobili*ation OR
experiences OR discomfort). Search limits that will be placed will include studies
reported in the English language, only human research, involve adults over 18 years
old only and have been published in last 15 years.
Data collection and analysis
Once an exhaustive literature search has been undertaken, studies that have been
obtained will be vetted against the inclusion and exclusion criteria for this review. The
article will be thoroughly scrutinised by three individual assessors and if it was suitable
it will go for data collection. Data collection from each study will take place on the form
included as Table 15. Either the risk ratios or odds ratios and 95% confidence intervals
will be calculated for all studies. Studies will then be grouped into similar mobilisation
times and results collated. These results will be presented in both Tables and on a
Forest Plot graph. Conclusions will be drawn from these.
Assessment of bias in studies
The risk of bias will be assessed by all three of the review authors, with a consensus
used when disagreements occurred. The Cochrane Collaboration’s tool will be used for
assessing bias (Higgins & Altman, 2008) to assess the risk of bias of the selected
randomised and quasi-randomised controlled trials (Table 2). Each of the criteria will
be scored ‘yes’, ‘no’ or ‘unclear’, depending on the information supplied in the report. A
Risk of Bias summary table for the review will be completed.
Sources of support:
Dalice A. Sim (PhD), Statistical Consultant from the School of Mathematics, Statistics
and Operation Research at Victoria University will provide assistance with the
statistical analysis in this Systematic Review and Meta-Analysis.
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Tables
Table 14: Risk of bias assessment tool Bias Quote: Comment: Was the allocation sequence randomly generated?
Was allocation adequately concealed from both participants and clinicians by having a secure schedule of randomization?
Were participants, clinicians and outcome assessors blinded to the allocated intervention adequately during the study?
Are results reported for everyone who entered the trial?
Was incomplete outcome data adequately addressed?
Were patients analysed in the groups to which they were randomised?
Are reports of the study free of selective outcome reporting?
Was the study apparently free of other problems that could put it at a high risk of bias?
Table 15: Data Collection Tool Source Study ID Report ID Review author ID Citation Eligibility Eligible for review Reason for exclusion. Methodology Research question / aim of study Country of study Setting of study/numbers of centres Study methodology Study duration Participants Control: Experimental
Group 1: Experimental Group 2:
Inclusion criteria Exclusion criteria Socio-demographics Ethnicity Total number participants Number of participants allocated to each group
Number of participants accounted for in results of each group
Age range / Mean age Gender distribution (% Women) Tool for comparison of demographic data between groups
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Figure given for statistically significant differences in demographics between groups
Results of comparison of demographic data between groups
Interventions Control: Experimental Group 1:
Experimental Group 2:
Specific intervention and details. Were specified procedures or components of the intervention implemented as planned?
Outcomes Control: Experimental Group 1:
Experimental Group 2:
Follow up and time points (i) collected; (ii) reported.
Outcomes to be measured, with diagnostic criteria if relevant.
Unit of measurement (if relevant). For scales: upper and lower limits, and whether high or low score is good.
Tools used for result analysis between groups
Results Control: Experimental Group 1:
Experimental Group 2:
Dichotomous data (OR,RR,RD) Continuous data (MD, SMD) Estimate of effect with 95% confidence interval; P value; Standard error, Standard deviations.
Subgroup analyses. Miscellaneous Did the authors declare any other potential conflict of interest?
Funding source for study Ethics Approval Study limitations Key conclusions from the study authors
Miscellaneous comments from the study authors
References to other relevant studies Notes Miscellaneous comments by the review authors.
References
Chair, S. Y., Li, K. M., & Wong, S. W. (2004). Factors that affect back pain among Hong Kong Chinese patients after cardiac catheterization. European Journal of Cardiovascular Nursing, 3(4), 279-285.
Chair, S. Y., Taylor-Piliae, R. E., Lam, G., & Chan, S. (2003). Effect of positioning on back pain after coronary angiography. Journal of Advanced Nursing, 42(5), 470-478.
Hay, D. (2004). Cardiovascular Disease in New Zealand. The National Heart
Foundation of New Zealand
104
Higgins, J. P. T., & Altman, D. G. (2008). Chapter 8: Assessing risk of bias in included studies. In J.P.T. Higgins & S. Green (Eds.), Cochrane Handbook for Systematic Reviews of Interventions (pp. 359-387). Chichester, England: John Wiley & Sons.
Rezaei-Adaryani, M., Ahmadi, F., & Asghari-Jafarabadi, M. (2009). The effect of
changing position and early ambulation after cardiac catheterization on patients' outcomes: A single-blind randomized controlled trial. International Journal of Nursing Studies, 46(8), 1047-1053.
Sabo, J., Chlan, L. L., & Savik, K. (2008). Relationships among patient characteristics,
comorbidities, and vascular complications post-percutaneous coronary intervention. Heart & Lung: The Journal of Acute and Critical Care, 37(3), 190-195.
Declarations of interest
There is no potential conflict of interest among the review authors.
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Chapter 5
DISCUSSION
The previous chapter contained the entire Systematic Review following the Cochrane
Collaboration framework. This chapter presents a discussion on the Systematic Review
findings and how these can impact on practice for nursing and other health professions
using an evidence-based approach.
The aim of this research was to ascertain what factors can be put in place by nursing
staff caring for patients after a femoral approach coronary angiogram to reduce back
pain, taking into account patient safety. When evaluated in the literature review, earlier
mobilisation proved to be the most successful intervention that a nurse can implement
to reduce back pain.
Literature review findings
The literature review found five different ways to potentially reduce back pain after a
diagnostic coronary angiogram procedure. By knowing the patient factors that have the
potential to increase back pain, a nurse can pre-empt the potential pain and administer
prophylactic pain relief or perhaps suggest to a doctor that a radial artery approach is
used or a vascular closure device is deployed post-procedure. By changing a patient’s
position whilst they are on bed rest such as side to side lying or back of bed elevation,
the nurse can help to prevent or relieve back pain after the angiogram procedure.
Medical staff could consider a radial artery approach to their coronary angiogram or
use a vascular closure device post-procedure, meaning the patient can sit up and
mobilise much quicker after their angiogram.
However, as discussed in the literature review in Chapter 2, there are limitations to all
of the above, and the gold standard and preferred access method around the world
remains the femoral artery (Hoglund et al., 2011). Vascular closure device use post-
femoral approach angiogram has not been widely adopted, despite their availability
(Dauerman et al., 2007). Only three of the five ways of preventing or reducing back
pain post angiography can be implemented by nursing staff. The decision to use a
radial artery approach or vascular closure device is made solely by the doctor involved.
Therefore, the Systematic Review and Meta-Analysis was undertaken to answer the
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research question as to the safety of earlier mobilisation, four hours or earlier post
femoral approach coronary angiogram, without using a vascular closure device.
Early mobilisation
Earlier mobilisation has many benefits to both the patient and nursing staff. It proved to
be a very successful way of reducing back pain after femoral approach coronary
angiogram, without increasing vascular complications, when analysed in the literature
review and then when formally evaluated in the Systematic Review. Getting out of bed
sooner also decreases urinary discomfort due to the fact that using a bedpan or urine
bottle whilst lying flat in bed can be difficult, leading to urinary retention and discomfort
(Chair et al., 2007). The intervention of early mobilisation can reduce costs (Best et al.,
2010), does not need any extra equipment or extra training, means a patient regains
their independence earlier leading to increased patient satisfaction and a free up of
nursing resources (Chair et al., 2007; Wang et al., 2001). When patients mobilise
sooner, without complications, they can be discharged earlier also freeing up nursing
resources and beds with the potential of increased patient throughput (Koch et al.,
1999).
The results of this Systematic Review showed that earlier mobilisation after femoral
approach coronary angiogram, without deployment of a vascular closure device, has a
positive benefit of reducing back pain related to lying in bed, confirming the findings in
the literature review. Of the four studies that directly measured back pain, three
showed very favourable results in their early mobilisation groups, when measuring
back pain compared to the control groups (Chair et al., 2007; Hoglund et al., 2011;
Wood et al., 1997). Only Wang et al. (2001) found higher levels of pain in the early
mobilisation group, but that was due to the inclusion of three patients with chronic back
pain who experienced severe pain on bed rest. Six of the other studies did not directly
measure back pain, but mentioned anecdotal comments that nurses had received
during the studies from patients regarding decreased back pain in the earlier
mobilisation groups. It was clearly shown in the Systematic Review that back pain is
significantly reduced when patients mobilise earlier after femoral approach coronary
angiograms.
The results of the Systematic Review also clearly showed that mobilisation at one and
a half hours to four hours after femoral approach coronary angiogram, without
deployment of a vascular closure device, has levels of vascular complication rates that
107
are not significantly different from those when the patient mobilises at six hours or later.
Therefore, this Systematic Review found it was probably safe to mobilise patients as
early as one and a half hours after a femoral approach diagnostic angiogram.
Comparison to the findings by Chair et al. (2008)
Similar favourable results to earlier mobilisation were found in the Systematic Review
by Chair et al. (2008), which was presented using the Joanna Briggs Institute format
(Joanna Briggs Institute, 2012). They concluded that there was no evidence of
decreased bleeding and haematoma formation in patients who remained in bed for
longer than three hours compared to those who mobilised earlier at three hours. They
found a decrease in back pain in those who mobilised earlier than three hours, as did
this Systematic Review. Chair et al. (2008) also state that there is a possibility of
benefit to back pain reduction with early mobilisation at two hours post femoral
approach coronary angiogram. However, they suggest further study on levels of
vascular complications at this earlier time frame.
This Systematic Review included three studies that were published after the study by
Chair et al. (2008) and one non-randomised controlled trial published in 1999 that, due
to its non-randomisation, did not fit the inclusion criteria set out by Chair et al. (2008).
This study was by Mah et al. (1999) that gave very favourable results to mobilisation at
three hours vs. five hours, in favour of the early mobilisation group (p = 0.00002).
Although back pain was not directly measured in this study, nurses noted that patients
made positive comments about comfort levels in the early ambulation group,
experiencing less discomfort than the control group. Best et al. (2010) conducted a
retrospective / prospective non-randomised controlled trial, which gave non-significant
differences in vascular complications between mobilisation at one and a half hours vs.
three to four hours (RR 1.0415; 95% CI 0.3968-2.7332; P 1.000). Anecdotal evidence
from nurses in this study found more favourable comments from patients in the early
mobilisation group around back pain and discomfort. However, for the same reason as
the study by Mah et al. (1999), this study would not have been included in the
Systematic Review of Chair et al. (2008).
The studies of Farmanbar et al. (2008) and Hoglund et al. (2011), would meet the
inclusion criteria of Chair et al. (2008) and when added to their Systematic Review,
would add weight to the conclusion that mobilisation four hours or less after femoral
approach coronary angiogram is both safe and potentially effective at reducing back
108
pain. Farmanbar et al. (2008) found a non-significant rate of vascular complications
when patients were mobilised at two hours vs. six hours (p = 1.000), as did Hoglund et
al. (2011), who mobilised patients at one and a half hours vs. five hours (p = 0.7749).
By including these two studies in the Systematic Review in this thesis, the
recommendations by Chair et al. (2007) to further study levels of vascular
complications at the earlier time frame of two hours or less have been followed,
evaluated and reported. Therefore, the findings by Chair et al. (2007) that there was no
evidence of decreased bleeding and haematoma formation in patients who remained in
bed for longer than three hours compared to those who mobilised earlier at three
hours, and that it is safe to mobilise at this time, can also be applied to mobilisation at
two hours, using the results from these two further studies. Hoglund et al. (2011) also
adds weight to the suggestion that earlier mobilisation potentially decreases the
incidence of back pain. As mentioned earlier, they found participants in their early
mobilisation group of one and a half hours experienced significantly less back pain at
the end of bed rest with a mean score of 1.5 / 10 compared to their control group who
mobilised at five hours and had a mean back pain score of 3.5 / 10. The result was
statistically significant at p < 0.001, favouring the early mobilisation group. Farmanbar
et al. (2008) did not measure back pain or discomfort.
Strengths of the Systematic Review
From the literature review, it was evident that early mobilisation after femoral approach
diagnostic coronary angiogram had already been researched in the form of eleven
randomised controlled trials, two quasi-randomised and two non-randomised trials.
Therefore, instead of carrying out further research on a topic that had already, clearly,
been well researched, a decision was made to perform a Systematic Review and Meta-
Analysis.
The topic of early mobilisation to reduce back pain is extremely relevant to nurses
today working in cardiac catheterisation laboratories and the wards that care for these
patients post-procedure. Numbers of coronary angiograms are increasing every year
(Galli and Palatnik, 2005) and have become one of the most frequently carried out
invasive procedures within hospitals (Leung, Hallani, Lo, Hopkins and Juergens, 2007).
After the angiographic procedure, the patient can remain on bed rest for at least 4-6
hours (Sabo, Chlan and Savik, 2008). It is evident back pain is a significant issue faced
by these patients on bed rest after a coronary angiogram (Augustin, de Quadros and
Sarmento-Leite, 2010; Chair et al., 2007; Hoglund, Stenestrand, Todt & Johansson,
109
2011; Pollard et al., 2003; Powers & Turner, 2000; Wang et al., 2001; Wood et al.,
1997). Leasure et al. (2008), Newhouse (2007) and Nursing Research (2012) state that
a hierarchy of evidence exists on which to base practice, ranked in order by the
strength of the evidence and that Systematic Reviews of rigorous randomised control
trials provide the strongest evidence. By completing this Systematic Review, using the
Cochrane Collaboration format, a strong piece of evidence has been created with
which to guide evidence-based practice. By combining these 15 studies, the strongest
and most powerful evidence for which a nurse can base their practice on has been
produced.
The Systematic Review contained 15 quantitative studies, 11 randomised controlled
trials, two quasi-randomised and two non-randomised trials, all with an intervention
group and control group. Deeks et al. (2008) discuss how only studies that are
homogeneous (i.e. similar in their participants, interventions, outcomes and study
design) should be compared in a Systematic Review and Meta-Analysis to provide
meaningful results. The studies in this Systematic Review were analysed for
homogeneity looking at study participants, interventions and outcome measures. All of
the studies analysed early mobilisation after femoral approach diagnostic coronary
angiogram. They all removed their femoral sheaths immediately with no prerequisites
except for no bleeding or haematoma at site. Haemostasis was gained using either
manual or mechanical compression but did not include vascular closure devices.
Medications used in each trial were very similar. Therefore, the studies were deemed
to have homogeneity and therefore could be compared in a Systematic Review. With
an amalgamation of the 15 studies, which included a total of 4581 participants, strong
evidence was gained, with a low level of bias due to the homogeneity of the included
studies.
Results from the Systematic Review and Meta-Analysis clearly showed no statistically
significant differences in levels of vascular complications in any of the studies between
the early mobilisation and control groups except in the case of Mah et al. (1999) who
showed significance results in favour of the earlier mobilisation group (p = 0.00002).
Publication bias was assessed to check for publication of only positive trials. Of the 15
studies included in this Systematic Review, eight studies showed a positive overall
result towards early mobilisation and six studies showed a negative overall result
towards early mobilisation. Therefore, publication bias was clearly not an issue in this
Systematic Review. Results from this Systematic Review have clearly shown that
mobilisation after femoral approach coronary angiogram, without deployment of a
110
vascular closure device, is as safe at one and a half hours to four hours mobilisation as
it is at six hours and may have a positive benefit of reducing back pain in patients
related to lying in bed.
Weaknesses of the Systematic Review
As part of the Cochrane Review process, levels of quality are allocated to individual
studies GRADE Working Groups grades of evidence (Schunemann et al., 2008). All 15
studies were assessed as having a moderate quality, due to four of the studies using a
quasi-randomised or non-randomised study design, which may increase the bias in the
studies (Best et al., 2010; Mah et al., 1999; Roebuck et al., 2000; Wang et al., 2001).
None of the 11 included randomised controlled trials had complete allocation
concealment or blinding and only two described their randomisation process (Chair et
al., 2007; Wood et al., 1997), which can also increase bias. A randomised controlled
trial is usually graded as a High quality rating on the using the GRADE levels of
evidence. The 15 studies in the Systematic Review would have been rated as High
quality, and therefore provided stronger evidence, had the studies all been randomised
controlled trials that revealed that they had complete allocation concealment, blinding
of at least medical staff performing the procedure and outcome assessors to reduce
study bias and declared their randomisation process. To overcome the bias created by
the quasi-randomised and non-randomised trials, after the initial analysis of all included
studies, each time frame was re-analysed including only the randomised controlled
studies.
Criteria for study inclusion in this Systematic Review meant included studies were
required to be published in English (due to the study authors inability to read other
languages). This creates potential bias, as studies published in other languages, that
otherwise would have met the inclusion criteria and could of added valuable
information, were excluded. There was also a 15 year limit applied to the studies i.e.
they needed to have been published in 1996 or later to be included, which meant older
studies, that again may have met the inclusion criteria and also added to the overall
outcome, were excluded.
Originally, the Systematic Review was to include early mobilisation for participants who
had undergone a Percutaneous Transluminal Coronary Angioplasty (PTCA). This was
stated in the study protocol prior to beginning the Systematic Review. However, only
five studies were identified in the literature search that included coronary angioplasty.
111
These studies proved to be too heterogenic in their methodology to be suitable for
comparison in this Systematic Review. Therefore the inclusion criteria for the
Systematic Review included only studies that looked at diagnostic coronary angiogram.
The results and recommendations from this Systematic Review would not be suitable
for application to patients post PTCA. Recommendations for further research on this
topic are included in the next chapter.
The research question for the Systematic Review (whether it is safe for nurses to
mobilise patients out of bed four hours or earlier after a femoral approach coronary
angiogram without the use of a vascular closure device, in order to reduce back pain
whilst not increasing the risk of vascular complications at the puncture site) had two
aspects that required research. Firstly, the early mobilisation and vascular complication
rates, which all of the included studies clearly researched. However, the second part of
the question, as to whether the early mobilisation decreased back pain was only
formally assessed by four of the studies (Chair et al., 2007; Hoglund et al., 2011; Wang
et al., 2001; Wood et al., 1997). Six other studies mentioned feedback from participants
in groups with a shorter time to mobilisation, about level of back pain, comfort or
satisfaction, without directly measuring it. Recommendations for further research into
this are discussed in the next chapter.
During the data collection process, it was noted that in two studies, it was unclear as to
whether vascular complications occurred before or after mobilisation. Both study
authors were contacted, with Jensen replying on behalf of Mah, Smith and Jensen
(1999), stating the complications were all after mobilisation. However, in the other
study by Pollard et al (2003), contact was not made. A decision was made to include
the study, as figures were given for the same time periods for both the control and
experimental group, and Chair et al (2008) had also included the study, with the same
figures, in their Systematic Review. This may have added a level of bias to the overall
Systematic Review, if in fact the figures were from prior to sheath removal through to
mobilisation as well. This potential bias was declared under Other Potential Bias in the
Results section of the Systematic Review.
The full text could not be located on one study that appeared to completely meet the
inclusion criteria, when the abstract was assessed (Tengiz et al., 2003). Despite an
extensive search, including emailing the magazine itself and searching 3 different
libraries databases, the full-text article of this study was unable to be located. The
abstract itself did not give enough information to result in the inclusion of the study.
112
Therefore I could not include it in my review and it was noted in the Characteristics of
Excluded Studies section of the Systematic Review. By excluding this study, valuable
information may have been lost that may of strengthened the argument towards earlier
mobilisation, or conversely supported later mobilisation.
Evidence-based practice
As nursing is a science and a profession, using evidence-based practice is
fundamental. It should always be based on the best available evidence (Newhouse,
2007). As discussed in Chapter 3, a hierarchy of evidence exists on which to base
practice, ranked in order by the strength of the evidence. Systematic Reviews of
rigorous randomised control trials sit at the top (Level I evidence) and provide the
strongest evidence. (Leasure et al., 2008; Newhouse, 2007; Nursing Research, 2012).
They are “the most powerful and useful evidence available” to guide practice (Stevens,
2001, p. 530). This Systematic Review followed the Cochrane Collaborations rigorous
and transparent framework and therefore gives the nurse and other health
professionals confidence that the results can be safely implemented into their practice.
Nurses and other health care professionals have little time to evaluate and synthesise
many different studies and can potentially rely on past experience and intuition in
making practice decisions (Acton, 2001). The value of this Systematic Review is that it
entails 15 individual studies, which are collated into one article of evidence with which
to guide their practice. This evidence can then be used to support the development of
best practice guidelines and practice protocols within an organisation involved with
femoral approach coronary angiograms. Implementation of these protocols involving
earlier mobilisation can then take place as part of evidence-based practice and
evaluation of the effectiveness of the new intervention can take place (Stevens, 2001).
This chapter has provided a discussion on ways to reduce back pain after femoral
approach diagnostic coronary angiogram and the intervention of early mobilisation. It
has presented the results from the Systematic Review included in this thesis and
compared the results to those of Chair et al. (2008) who also completed an earlier
Systematic Review on this topic. It also shows what this Systematic Review adds to
what was already known from the Systematic Review by Chair et al. (2008). The
chapter has presented the strengths and weaknesses of the Systematic Review and
how using this Systematic Review as a basis for evidence-based practice will benefit
nursing. The following chapter will provide a summary of this thesis, including
implications for practice and further research.
113
Chapter 6
CONCLUSION
This final chapter will summarise the findings of the Systematic Review, introduce
implications for practice and further research and conclude the thesis.
This thesis has clearly shown that back pain is an issue for patients who are required
to remain on bed rest post-femoral approach coronary angiography. Although other
methods have been presented to reduce the back pain, early mobilisation prior to four
hours is safe, simple to implement, has a proven effect on back pain reduction and has
added benefits such as decreased urinary discomfort, reduction in costs and means a
patient regains their independence earlier leading to increased patient satisfaction and
a free up of nursing resources.
Implications for practice
The Systematic Review included in this thesis aimed to provide an evidence-based
argument that time to mobilisation can be decreased to four hours or earlier in patients
post-femoral approach diagnostic coronary angiogram. It also aimed to show a
decrease in the potential for back pain whilst maintaining a risk of vascular
complications the same or lower than patients who mobilise at the traditional longer
regime. The results from the Systematic Review showed no statistically significant
difference in vascular complications between the control groups and the early
mobilisation out of bed groups at ≤ 2, 3 or 4 hours post femoral approach coronary
angiogram. Therefore, mobilisation after femoral approach coronary angiogram,
without deployment of a vascular closure device, may be as safe at one and a half
hours to four hours mobilisation as it is at six hours and may have a positive benefit of
reducing back pain related to lying in bed.
Due to the results of this study, the Interventional Cardiology Unit at Capital and Coast
Health Board’s Wellington Regional Hospital has decided to start mobilising patients
after a femoral approach diagnostic coronary angiogram at three hours post-procedure,
with back of bed elevation after one hour. If this proves successful in this unit, the
decision will then be made as to whether to trial a change of practice to two hours to
mobilisation. Before the Systematic Review was compiled, this unit mobilised patients
at four hours, with back of bed elevation after two hours.
114
Implications for research
The Systematic Review included in this thesis contained both randomised controlled
trials and quasi-randomised / non-randomised controlled trials, with a separate analysis
of just the randomised controlled trials. Although non-randomised controlled trials can
add valuable information to evidence-based practice, it would be beneficial if any
further studies on this topic were randomised controlled trials. This lowers the risk of
bias and ensures they can be included in a Systematic Review in the future.
As stated in the Systematic Review, further research on early mobilisation post femoral
approach coronary angiogram on a higher number of female patients would be of
benefit. Female patients make up fewer numbers in presentation for coronary
angiography as was seen in all fifteen of the studies included in the Systematic Review.
Because of this, numbers were lower in female participants and therefore the results
would be more heavily weighted towards men. Therefore, conducting further research
on primarily female patients could lead to results that are more applicable to the female
coronary angiography population.
Initially, the Systematic Review in this thesis was to also include patients who had
undergone a femoral artery approach coronary angioplasty. However, only five studies
were identified in the literature search that included coronary angioplasty. These
studies proved to be too heterogenic in their methodology to be suitable for comparison
in a Systematic Review. Therefore the inclusion criteria for the Systematic Review
included only studies that looked at diagnostic coronary angiogram. Further research
needs to be undertaken on the timing of mobilisation and femoral approach coronary
angioplasty before it can be concluded safe to mobilise these patients earlier. The
methodology and inclusion / exclusion criteria in these studies should have enough
homogeneity that the studies could be compared in a Systematic Review and Meta-
Analysis.
Conclusion
In conclusion, back pain is an issue for patients who are required to remain on bed rest
post-femoral approach coronary angiography. The results of the Systematic Review in
this thesis clearly showed that mobilisation at one and a half hours to four hours after
femoral approach coronary angiogram, without deployment of a vascular closure
device, has levels of vascular complication rates that are not significantly different from
those when the patient mobilises at six hours or later, therefore is safe. This
115
Systematic Review and the earlier one carried out by Chair et al. (2008) both found
that back pain is significantly decreased with earlier mobilisation. This information can
now be accessed by nurses and other health professionals working in the area of
coronary angiography and be used to change practice and protocols. This will lead to
increased patient satisfaction whilst maintaining safe practice.
116
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APPENDICES
Appendix V: Research Notification Form Research Notification Form 1. Applicant details
1.1 Name of Applicant(s) Kelly Burn
1.2 Position of Applicant(s) MN Candidate
1.3 School and Faculty EIT Hawkes Bay
1.4 Contact Phone 0211727848
1.5 Supervisor (if applicable) Bob Marshall / Gill Scrymgeour
1.6 Project Title What factors reduce back pain in adult patients on bed rest after coronary angiography, whilst avoiding vascular complications due to femoral artery puncture?
1.7 Project Start Date and Duration
2 May 2011 - 22 June 2012
2. Attach the completed Low Risk Research Questionnaire 3. If your project has been approved by another Ethics Committee, include your
application to them as well as their final approval letter.
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Appendix VI: Low Risk Research Questionnaire
LOW RISK RESEARCH QUESTIONNAIRE (Part A and Part B of this questionnaire must both be completed) Name: Kelly Burn Project Title: What factors reduce back pain in adult patients on bed rest after
coronary angiography, whilst avoiding vascular complications due to femoral artery puncture? (A Systematic Review)
Part A The statements below are being used to determine the risk of your project causing physical or psychological harm to participants and whether the nature of the harm is minimal and no more than is normally encountered in daily life. The degree of risk will then be used to determine the appropriate approval procedure. If you are in any doubt you are encouraged to submit an application to EIT’s Research Ethics and Approvals Committee. Does your Project involve any of the following? (Please answer all questions. Please indicate either YES or NO for each question) Risk of Harm 1. Situations in which the researcher may be at risk of harm. NO
2. Use of questionnaire or interview, whether or not it is anonymous which might reasonably be expected to cause discomfort, embarrassment, or psychological or spiritual harm to the participants.
NO
3. Processes or results that are potentially disadvantageous to a person or group, such as the collection of information which may expose the person/group to discrimination. NO
4. Collection of information of illegal behaviour(s) gained during the research which could place the participants at risk of criminal or civil liability or be damaging to their financial standing, employability, professional or personal relationships.
NO
5. Collection of blood, body fluid, tissue samples or other samples. NO
6. Any form of exercise regime, physical examination, deprivation (e.g. sleep, dietary). NO
7. The administration of any form of drug, medicine (other than in the course of standard medical procedure), placebo. NO
8. Physical pain, beyond mild discomfort. NO
9. Any EIT teaching which involves the participation of EIT students for the demonstration of procedures or phenomena which have a potential for harm. NO
Informed and Voluntary Consent 10. Participants whose identity is known to the researcher who give oral consent rather
than written consent (if participants are anonymous, you may answer No). NO
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11. Participants who are unable to give informed consent. NO
12. Research on your own students/pupils. NO
13. The participation of children (seven (7) years old or younger). NO
14. The participation of children under sixteen (16) years old where parental consent is not being sought. NO
15. Participants who are in a dependent situation, such as people with a disability, or residents of a hospital, nursing home or prison or patients highly dependent on medical care.
NO
16. Participants who are otherwise vulnerable. NO
17. The use of previously collected information or biological samples for which there was NO explicit consent for this research. NO
Privacy/Confidentiality Issue 18. Any evaluation of EIT services or organisational practices where information of a
personal nature may be collected and where participants may be identified. NO
Deception 19. Deception of the participants, including concealment and covert observations. NO
Conflict of Interest 20. Conflict of interest situation for the researcher (e.g. is the researcher also the
lecturer/teacher/treatment-provider/colleague or employer of the research participants or is there any other power relationship between the researcher and the research participants?)
NO
Compensation to Participants 21. Payments or other financial inducements (other than reasonable reimbursement of
travel expenses or time) to participants. NO
Procedural 22. A requirement by an outside organisation (e.g. a funding organisation or a journal in
which you wish to publish) for EIT’s Research Ethics and Approvals Committee approval.
NO
Part B The statements below are being used to determine if your project requires ethical approval by a Regional Health and Disability Ethics Committee. (http://www.hrc.govt.nz/assets/pdfs/policy/ReferralGuidelines.pdf) In situations where you are not sure whether the research needs approval by an HDEC, you should seek an opinion from the Administrator of the relevant HDEC. (http://www.ethicscommittees.health.govt.nz/) Include a copy of your written response from the Administrator with your application. Does your Project involve any of the following? (It is important that you answer all questions. Please circle either YES or NO for each question)
130
23. The use of staff or facilities of a health provider (e.g. DHB, PHO or health NGO). NO
24. Support, directly or indirectly, in full or in part, by health provider funds (e.g. DHB, PHO or health NGO). NO
25. Participants who are patients/clients of, or health information about an identifiable individual held by, an organisation providing health services (for example, general practice, physiotherapy, occupational therapy, sports medicine), disability services, or institutionalised care.
NO
26. Requirement for ethical approval to access health or disability information about an identifiable individual held by the Ministry of Health, or held by any public or private organisation whether or not that organisation is related to health.
NO
Determine the type of approval procedure to be used (choose one option):
If you answer YES to any of the questions 1 to 22 (Part A) and NO to all questions in Part B Prepare an application for the EIT C’tee using the RAD form.
If you answer YES to any of the questions 23 to 26 (Part B) Prepare an application using the Health & Disability Ethics Committee Application Form
If you answer NO to all of the questions Complete the Research Notification Form
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