The Impact of Enteral Feeding Protocols on Enteral Nutrition Delivery: Results of a multicenter observational study

Rupinder Dhaliwal, RD Daren K. Heyland, MD

Naomi E Cahill, RDXiaoqun Sun, MSc

Andrew G Day, MScStephen A. McClave, MD

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Background

Feeding protocols are considered to be an effective strategy

to maximize the benefits and minimize the risks of enteral nutrition

in critically ill patients.

Components of feeding protocols may include orders for Early initiation of enteral nutrition Use of motility agents Gastric residual volumes Head of the bed elevation Use of small bowel feeding tubes

The benefits of such protocols would be: to standardize the delivery of EN to automate the provision of EN

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“Use of a feeding protocol that incorporates prokinetics at initiation, higher GRVs (250 mls) and use of post pyloric feeding tubes should be considered”

What do Guidelines say?

“Evaluating gastric residual volume (GRV) in critically ill patients is an optional part of a monitoring plan to assess tolerance of EN. “ Avoid holding EN when GRV < 250 mls.Consensus, imperative

“Use of enteral feeding protocols increases the overall percentage of goal calories provided and should be implemented.” Avoid holding EN for GRVs < 500 mls. Grade: C, B

RCT Level of Evidence

RCTs of aggressive feeding protocols Results in better protein-energy intake Associated with reduced complications and improved survival

Taylor et al Crit Care Med 1999; Martin CMAJ 2004; Doig GS JAMA 2008

However, the estimates of their effectiveness are limited due to: the nature of small single-center studies the bundling with many other interventions in cluster randomized controlled trials.

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To evaluate the effect of an ICU site-based feeding protocol on nutrition practices and outcomes in the context of an international multicenter, observational study.

ObjectiveTo compare the following performance criteria between sites that did or did not use a feeding protocol:

Use of EN

Time to start EN

Adequacy of enteral nutrition

Adequacy of overall nutrition

Clinical outcomes

PurposePurpose

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Primary Outcomes

Overall nutritional adequacy

Enteral nutrition adequacy

Overall nutritional adequacy = as the total amount of calories or protein received (from EN + appropriate PN + propofol) /prescribed x 100%

Overall EN adequacy = as the total amount of calories or protein received (from EN) /prescribed x 100%

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MethodsData from two international, prospectively, observational cohort studies conducted in 2007 and 2008 were combined.

Patients: Consecutively enrolled mechanically ventilated adults In ICU > 3 days

Data was collected from ICU admission to a maximum of 12 days: sites recorded the presence or absence of a feeding protocol timing, type and amount of nutrition received strategies utilized to improve nutrition delivery (m. agents, small bowel feeds, HOB) 60 day mortality, hospital and ICU length of stay and duration of mechanical

ventilation Each participating ICU aimed to recruit 20 patients.

Nutrition practices and clinical outcomes were compared between ICUs that used a feeding protocol and those who did not.

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Data ManagementData entered on to our secure online edcs, built-in range checks

and data query process.

1 www.criticalcarenutrition.com

Data Analysis

Data from 2007 and 2008 combined, 334 total sites, 65 sites participated both years, 269 unique ICUs

Hospital and ICU characteristics compared at the site level

All other variables were compared at the patient level

Clustered 2 stage sample design: patient and site, so potential for heterogeneity between ICUs.

Advanced statistical methods were done to account for heterogeneity (adjusted chi square tests, multilevel modelling).

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Results

269 ICUs participated from 28 countries

2007: 128/167 (77%) used protocol

2008: 132/167 (79%) used protocol

Protocol No Protocol

208/269 (77%) 61/269 (23%)

Results269 ICUs participated from 28 countries

Canada 46/57 (80.7%)

USA 48/77

(62.3%)

UK19/19

(100%)

Australia28/28

(100%)

New Zealand

6/7 (85.7%)

India5/9

(55.5%)

Brazil2/4 (50%)

China16/25 (64%)

Italy7/7

(100%)

Ireland7/7

(100%)

29/61 (48%) of the non-protocolized sites being from the United States.

Results: Site CharacteristicsTable 1. Protocol (n=208)

(77%)No Protocol (n=61) (23%)

P value

Hospital Type Teaching Non Teaching

162 (77.9%)46 (22.1%)

51 (83.6%)10 (16.3%)

0.38

Size hospital mean (range) 606 (108-2502) 791 (138-4000) 0.004

Multiple ICUs in hospital yes

107 (51.4%) 45 (73.8%) 0.002

ICU structureOpenClosedOther

48 (23.1%)156 (75.0%)4 (1.9%)

22 (36.1%)39 (63.9%)0 (0%)

0.099

Medical Director 196 (94.2%) 54 (88.5%) 0.15

Case Types Medical Surgical

189 (91%)191 (92%)

44 (72%)49 (80%)

0.00040.017

Size ICU 17 (4-75) 19 (5-48) 0.50

Presence of ICU Dietitian 168 (80.8%) 46 (75.4%) 0.37

FTE RD per 10 beds 0.4 (0.0-6.7) 0.3 (0.0-1.0) 0.42

Avg. # eligible patients contributed/year

17.0 (range: 1-24) 14.6 (range: 1-25) p=0.001

Characteristics Total

n=269

Feeding Protocol

Yes 208 (77%)

Gastric Residual Volume Tolerated in Protocol

Mean (range) 213 ml (50, 500)

Elements included in Protocol

HOB Elevation 71.2 %

Motility agents 68.5%

Small bowel feeding 55.2%

Results: Feeding Protocols

15.2% using the recommended

threshold volume of 250 ml

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Results: Patients n = 5497

Table 2. Protocol No Protocol P value

Number of Patients n=4416 n=1081

age 59.6 (12-96) 58.8 (15-99) 0.38

Gender 1771 (40.1%) 380 (35.2%) 0.013

Admission categoryMedicalSurgical

2792 (63.2%)1624 (36.7%)

633 (58.6%)448 (41.4%)

0.30

APACHE II 22.4 (1-72) 21.9 (1-46) 0.31

Presence of ARDS 554 (12.5%) 137 (12.7%) 0.96

Mechanical Ventilation median (IQR) 8 (4-16.2) 7 (3.6-14)

0.089

Hospital LOS 21.9 (12.9-36.0) 20.7 (12.6-32.0) 0.25

Mortality 60 day 1280 (29.0%) 295 (27.3%) 0.37

1Heyland JPEN 2010 ( in press)

Results: Nutrition outcomesTable 3. Protocol No Protocol P value

Number of Sites 208/269 (77%) 61/269 (23%)

EN alonePNEN + PNNone

3108 (70.4%) 322 (7.3%)785 (17.8%)201 (4.6%)

688 (63.6% )116 (10.7%)184 (17.0%)93 (8.6%)

0.0036

Time to start of EN from ICU admission

41.2 hrs 57.1 hrs 0.0003

motility agents use in high GRVs

811 (64.3%) patients

103 (49.0%) patients

0.0028

average head of bead elevation

32.5o 30.0o 0.017

small bowel feeding in high GRVs

177 (14.0 %)patients

35 (16.7%)patients

0.45

1Heyland JPEN 2010 ( in press)

Results: Nutrition Adequacy

Protocol No Protocol

Adequacy from EN 45.4% 34.7% p<0.0001

Overall nutritional adequacy

61.2 % 51.7% p=0.0003

1Heyland JPEN 2010 ( in press)

EN adequacy: multilevel model

After adjusting for the effect of:

significant patient characteristics (age, BMI, gender, # days in ICU, surgical vs. Medical, APACHE II)

site level characteristics of EN adequacy (year of survey, vs. Non teaching, closed, RD, glycemic protocols)

The expected average EN adequacy over the first 12 ICU days

Unadjusted Adjusted

by 7.4% (SE=1.8%, p<0.0001) in patients from sites with protocols

by 4.1% (SE=1.8%, p=0.021) in patients at sites with protocols

1Heyland JPEN 2010 ( in press)

Conclusions

There is great variation in the use of feeding protocols in ICUs across the World.

The presence of an enteral feeding protocol is associated with significant improvements in the use of EN, timing of initiation of EN, the use of motility agents and nutrition adequacy delivered.

We suggest that the use of feeding protocols become standard of care in ICUs.

Despite the use of protocols, overall nutrition adequacy is still below target, further refinement and optimization of the characteristics of feeding protocols is warranted.

The positive effect of feeding protocols on clinical outcomes is yet to be established.

1Heyland JPEN 2010 ( in press)

Strengths and Weaknesses

Weaknesses observational nature of the study design did not standardize the specific nutrition interventions included in

the feeding protocols did not optimize the utilization of protocols at each site. We are

unable to comment on the quality of these existing protocols or the level of compliance at the bed-side.

Strengths large number of participating sites from around the world Use of a structured, validated data capture system, which

enhances the generalizability and validity of the observations.

1Heyland JPEN 2010 ( in press)

Efficacy of Enhanced Protein-Energy Provision via the Enteral Route

in Critically Ill Patients: The PEP uP Protocol

A Single center feasibility trial

Acknowledgements

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The authors are grateful to the critical care practitioners from all participating ICU sites for their dedication and commitment to collecting data for this study.

Colleagues at the Clinical Evaluation Research Unit

Naomi Cahill currently holds a Canadian Institutes

for Health Research (CIHR) Fellowship in

Knowledge Translation.

All authors declare no conflicts of interest relevant to the

subject of this manuscript.