An Update on Procedural Sedation

8/14/2019 An Update on Procedural Sedation

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An Update on Procedural Sedation

A Primer on the Rules!

Shiva Birdi M.D.

Staff Anesthesiologist and Intensivist

Anesthesiology Institute

Cleveland ClinicMay 14, 2009


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primum non nocereFirst, Do No Harm


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Objectives

Background

Continuum of Sedation

New JCAHO StandardsPatient Selection & Credentialing

Process and Quality Improvement

Final Thoughts


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Objectives

Background




Final Thoughts


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The Old Conscious Sedation

Inconsistent pre-procedure screening

NO requirement for

documentationNO major monitoringstandards

NO quality or

performanceevaluationrequirement

NO credentialingrequired


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Goals of Procedural Sedation

Patient Comfort

Reduce Pain

Reduce Anxiety

Patient SafetyMaintain cardiopulmonary function

Minimize and manage related complications

Improve EfficiencyOptimize procedural conditions

Adequate Recovery

Patient returned to pre-procedural functional

and physiologic level


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A Bit of History

Midazolam (Versed) introduced inUnited States in mid 1980s

86 Deaths in first 5 years of useMajority related to proceduralsedation

Epstein B. Department of Health and Human Services, Office of Epidemiology and Biostatistics,

Center for Drug Evaluation and Research. Data Retrieval Unit HFD-737; June 27, 1989.


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Dangers of Sedation

Bailey et al.

Healthy Volunteers

Given midazolam, fentanyl or bothHypoxemia (92%) and Apnea (50%)

combination of midazolam and fentanyl

Reported to Department of Healthand Human Services

Bailey et al. Anesthesiology. 73(5):826-830, Nov 1990


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Dangers of Sedation

Iber et al. 1

10 pts developed Apnea or CardiopulmonaryArrest during or following endoscopy

Arrowsmith et al. 2

ASGE/FDA Collaborative Study

>21K GI endoscopy procedures

Serious CV complications 5.4 / 1000

Vargo et al. 3

49 pts upper endoscopy

57% with 54 episodes of apnea (>30 sec)

50% with hypoxemia1Iber FL et al. J Clinical Gastroenterology 1992; 14:10913

2Arrowsmith et al. Gastrointestinal Endoscopy, 1991; 37:42173Vargo et al. Gastrointestinal Endoscopy 55:826-831, 2002


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98,000 Preventable Deaths

$17 billion to $29 billion cost


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MAC claims

> 40% with death or

brain damage

Most common injury

Respiratorydepression fromover-sedation

Median Payment

$240,000


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44% judged to be PREVENTABLEBy

Better Monitoring

(pulse oximetry, capnography, improvedvigilance, or audible alarms)


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Mainstream Media


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Dangers of Sedation

Airway Disaster / Aspiration

Respiratory Depression

Cardiovascular ComplicationsParadoxical Response to sedation

Medication Related Events

Inadequate Sedation / Movement

Nausea and Vomiting

Patient Dissatisfaction


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Possible Solutions ?

Provider Education andTraining

Patient Selection

Improved Monitoring

Increased VIGILANCE


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Objectives

Background




Final Thoughts


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Continuum of Depth of Sedation(Developed by the American Society of Anesthesiologists)

(Approved by ASA House of Delegates on October 13, 1999,and amended on October 27, 2004)

Usually maintainedUsually maintainedCardiovascularFunction

May be inadequateAdequateSpontaneousVentilation

Intervention may berequired

No intervention requiredAirway

Purposeful* responsefollowing repeated orpainful stimulation

Purposeful* response to verbalor tactile stimulationResponsiveness

Deep Sedation /Analgesia

Moderate Sedation / Analgesia(Conscious Sedation)

* Reflex withdrawal from a ainful stimulus is NOT considered a ur oseful res onse


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Moderate Sedation/Analgesia

The Old Conscious Sedation

Patient RESPONDS PURPOSEFULLY

to verbal commands/light stimulationNO airway manipulation required

Spontaneous ventilation maintained

Cardiovascular function usuallymaintained


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Deep Sedation/Analgesia

Patient not easily aroused

Patient RESPONDS PURPOSEFULLY

to repeated or painful stimulationAirway manipulation MAY BErequired

Spontaneous ventilation MAY BEinadequate

Cardiovascular function usually

maintained


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Some Exclusions

Preoperative medications

Patient controlled analgesia

Post-operative or labor analgesia

Pain Management (dressings, burns orangina)

Sedation in the intensive care unit

Sedation for treatment of insomnia

Anxiolysis (single dose)

Drug or alcohol withdrawal or prophylaxis

Treatment of seizure disorders


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As the details

became more andmore transparent


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The Joint Commission waswatching


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and after thorough survey,inspection and review


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STANDARDS UPDATED

Adopted ASA Evidence Based Guidelinesand Depth of Sedation Continuum

Joint Commission on Accreditation ofHealthcare Organizations: "Standards andIntents for Sedation and Anesthesia Care,"

in Revisions to Anesthesia Care Standards,Comprehensive Accreditation Manual forHospitals. Oakbrook Terrace, Ill., JointCommission on Accreditation of Healthcare

Organizations, 2001. (updated 2004)


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Comparable Care Mandate

There must be no decrement

in the care delivered to patientsduring their entire continuum of

care within the hospital.


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Bottom Line

All conscious sedation areas (OR

and non-OR) must have processes(pre-sedation assessment, intra-procedure monitoring, discharge

criteria), facilities, equipment,and personnel similar to thoseutilized for MAC delivered byqualified anesthesia providers in theOR.


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JCAHO Standards

Assessment of Patients (PE)

Care of Patients (TX)

Improving Organizational

Performance (PI)


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JCAHO Standards

Assessment of Patients (PE)PE.1.8.1

Any patient for whom moderate or deep sedation oranesthesia is contemplated receives a pre-sedation or

pre-anesthesia assessmentPE.1.8.2

Before anesthesia, the patient is determined to be anappropriate candidate for anesthesia.

PE.1.7.3

The patient is re-evaluated immediately beforeanesthesia induction

PE.1.8.4

The patient's postoperative status is assessed onadmission to and discharge from the post-anesthesia

recovery area Cohen et al. ASA Newsletter. May 2001


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JCAHO Standards

Care of Patients (TX)TX.2.0

Moderate or deep sedation and anesthesia are providedby qualified individuals

TX.2.1A pre-sedation or pre-anesthesia assessment isperformed for each patient before beginning moderate ordeep sedation and before anesthesia induction.

TX.2.1.1

Each patient's moderate or deep sedation and anesthesiacare is planned.

TX.2.2

Sedation and anesthesia options and risks are discussedwith the patient and family prior to administration

Cohen et al. ASA Newsletter. May 2001


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JCAHO Standards

Care of Patients (TX) contd.TX.2.

Each patient's physiological status is monitored duringsedation or anesthesia administration

TX.2.4The patient's post-procedure status is assessed onadmission to and before discharge from the post-sedation or post-anesthesia recovery area

TX.2.4.1

Patients are discharged from the post-sedation or post-anesthesia recovery area and the organization by aqualified LIP or according to criteria approved by themedical staff.

TX.3.5.5

Emergency medications are consistently available,controlled and secure in the harmac and atient care

Cohen et al. ASA Newsletter. May 2001


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JCAHO Standards

Improving Organizational Performance(PI)

PI.4.

Data are systematically aggregated and analyzedon an ongoing basis

PI.4.2.

The organization compares its performance overtime and with other sources of information

PI.4.3.

Undesirable patterns or trends in performance andsentinel events are intensively analyzed .

PI.4.4.

The organization identifies changes that will lead toCohen et al. ASA Newsletter. May 2001


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What this meansfor the Provider?


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Objectives

Background




Final Thoughts


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Patient Selection

Planned Procedure

Associated physiologic derangements

Patients Medical StatusCoMorbid Conditions

Preoperative Status is Optimized

Airway Exam

NPO Guidelines

Intended Level of Sedation/Analgesia

Must be decided in advance


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Pre-Procedure Assessment

Focused H&P

Summary of Patient Current Condition

Review Medications and Allergies

Review of Co-Morbid DiseasesPrevious adverse rxn to sedation/anesthesia

Last PO Intake (time and nature)

Cardiac, Pulmonary and Airway exam

MUST be reviewed immediately prior toprocedure for any changes


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ASA Classification

E: after the Class would represent an

emergency

f


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ASA Classification

ASA Closed Claims Study (for sedation)1age greater than 70 years

ASA physical status III to V

THESE RESULTED IN HIGHER LITIGATION

1Bhananker, S et al. Anesthesiology. 2006:Feb;104(2):228-234.

ll


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Mallampati Score

ll S


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Mallampati Score

MAY BE HIGHRISK FORAIRWAY

DIFFICULTIES

OTHER RELAVANT HISTORY:

H/O Snoring

Thick NeckDifficulty with Neck ROM

Hi h Ri k P i


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High Risk Patients

Extremes of Age

Severe cardiac,pulmonary, renal,

or hepatic disease(ASA class III)

Potential difficultintubation(MP score III)

Pregnancy

H/o drug abuse orEtOH abuse

H/o difficulty withsedation oranesthesia

DEEP Sedation isplanned

Hi h Ri k P ti t


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High Risk Patients

Extremes of Age

Severe cardiac,pulmonary, renal,

or hepatic disease(ASA class III)

Potential difficultintubation(MP score III)

Pregnancy

H/o drug abuse orEtOH abuse

H/o difficulty withsedation oranesthesia

DEEP Sedation isplanned

IF ONE or MORE of these risk factorsAnd DEEP sedation planned

CONSIDER GETTING ANESTHESIOLOGY INVOLVED


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Ohi B d f N i


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Ohio Board of Nursing( July 2007)

RN (not CRNA) cannot engage inadministration of medications thatinduce DEEP SEDATION or GENERAL

ANESTHESIA

RN cannot engage in activities thatdivert attention away from thepatient

www.nursing.ohio.gov

R i t d N C d ti l


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Registered Nurse Credentials

INSTITUTIONAL CREDENTIALING REQUIREMENTS +

Supervised by LIP (Moderate Sedation Only)

PharmacologyAge- and weight- related dosage, reversals

Monitoring

Pulse oximetry, Cardiac monitors

Level of consciousness assessmentPain assessment

Arrhythmia recognition

Basic Airway management

***Recognition of Deep Sedation***

S d ti P ti


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Sedation Practice(JCAHO and ASA Guideline)

Understand Sedation Continuum

Difficult to predict individual patientresponse to sedation

MUST be able to RESCUE patientfrom next level of sedation

MODERATE DEEP

DEEP GA

RESCUE d RETURN


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RESCUE and RETURN(JCAHO and ASA Guideline)

Sedation Practitioner must be able toRESCUE a patient one level abovethe intended level of sedation

After RESCUE the patient isRETURNED to the original intendedlevel of sedation

Ph i i C d ti li


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Physician Credentialing

Each organization is free to define how it willdetermine that the individuals are able to performthe rescue (JCAHO Feb, 2009)

Physicians administering or supervisingmoderate or deep sedation/analgesia should haveappropriate education and training (ACS ST-46

April 2004)

Only physicianswith adequate training,education and licensure to administer moderatesedation should supervise (ASA Statement

October 2006)

Ph i i C d ti li


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Physician Credentialing

ER, ICU excluded

Competency and Training in:

Oxygen delivery systemsBasic cardiovascular physiology

Pharmacology of sedatives and reversalagents

Understanding and knowledge ofrequired and emergency equipment

KNOW HOW TO CALL FOR HELP !

M d t S d ti


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Moderate Sedation

Sedation/Analgesia Training andPrivileging

Institution dependent

(ex. Online or Live Sedation Course followed by aquiz)

***Recognition of Deep Sedation***

Basic Resuscitative TechniquesBCLS (renew every years)

Demonstrate proficiency in airwaymana ement with ba -mask ventilation

Deep Sedation


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Deep Sedation

Deep Sedation


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Deep Sedation

Requirements for Moderate Sedation +

Advanced Resuscitative Techniques

ACLS, ATLS (renew every 2 years)

Demonstrate ability to manage associatedcomplications including slipping into General

Anesthesia

Advanced airway management skills including useof airway assist devices and managecompromised airways

ex. Airwa worksho offered at institution

Equipment


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Equipment

Oxygen Supply

Pulse Oximetry

Blood Pressure

*EKG* (as indicated for at risk patient inmoderate but a MUST for deep)

*Capnography* (beneficial adjunct for

monitoring adequacy of ventilation)Does not replace examination of patient

Emergency equipment

Suction

Crash Cart

Special Note


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Special Note

Supplemental oxygen decreasesincidence of hypoxemia

Adequate OXYGENATION does notmean adequate VENTILATION

REVERSAL agents (Naloxone,Flumazenil) must be available

IV access must be maintainedthroughout the procedure andrecovery phase

Procedural Sedation Record


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Procedural Sedation Record

Performed by a Dedicated Qualified Assistant

Document Vitals at regular intervals

Moderate sedation (q 10 min)

Deep sedation (q 5 min)

Pain and Sedation Scoring System

Oxygen Saturation and Respiratory Rate

Level of consciousness (ex. Ramsey Scale)

Verbal and visual exam by monitoring assistant

Airway Manipulation Interventions

Chin lift, Jaw thrust, adjunct airway, MV, etc.

May assist in post procedure audit

Recovery


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Recovery

Standards of Monitoring continue

Appropriate staff available

Documentation continues

In-patients

must return to baseline function andphysiological status prior to return to RNF

Out-patientsalert and oriented

stable vital signs

baseline ambulation status

pain and nausea well controlled

Objectives


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Objectives

Background



Process and Quality

ImprovementFinal Thoughts

Quality Improvement


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Quality Improvement

Hospital Quality Improvement

Certification of Procedure Sedation Site

Oversight of sedation practice and evaluation

of patient outcomesMonitor and Identify System Failures toReduce Incidence of Sentinal Events*

*A sentinel event is an unexpected occurrenceinvolving death or serious physical orpsychological injury, or the risk thereof .

*Joint Commission Standards

Quality Improvement


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Quality Improvement

Department Quality Improvement

Applies to each department providingModerate Sedation

Systematically gather and analyze dataon a continuous basis

Establish Department Specific Quality

Markers and ThresholdsDevelop Quality Reports that arereviewed by Hospital QI

Perform regular reviews

Examples of Quality Markers


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Examples of Quality Markers

ANY need to Rescue patients fromunintended deeper level of sedation

ANY usage of airway manipulationmaneuvers

ANY major change in VS (Sat/BP)

ANY major cardiopulmonary eventANY use of reversal agents

ANY prolonged recovery phase

Objectives


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Objectives

Background




Final Thoughts

Final Thoughts


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Final Thoughts

PATIENT SELECTION IS CRITICAL

Anesthesia involvement for patientsat high risk for sedationcomplications

Titration of sedative / analgesics

Adequate oxygenation DOES NOTequal adequate ventilation

EARLY RECOGNITION OF DEEPERTHAN INTENDED SEDATION

Key Resources


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Key Resources

Continuum of Depth of Sedation

ASA Sedation Guidelines for Non-Anesthesiologists

Pass the Survey!


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Pass the Survey!

CREDENTIALING MUST BEMAINTAINED!

EVERY PATIENTS PROCEDURALSEDATION PLAN SHOULD BEINDIVIDUALIZED

Avoid COOKBOOK Techniques

Pass the Survey


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Pass the Survey

Quality and Process ImprovementStrategies employed across theInstitution

Compliance with JCAHO ComparableCare Mandate

PRIMARY GOAL: PATIENT SAFETY

Conclusion


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Conclusion

Procedural Sedation is extremely

Safe and Effective

when performed on well selected,adequately informed patients, by

appropriately trained, credentialed,

and well supported providers.


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ADEQUATE PREPARATION LEADS TO A

SAFE, EFFECTIVE AND SATISFACTORY

EXPERIENCE

QUESTIONS ?


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QUESTIONS ?

Todays Presentation and supportingdocuments available online:

www.CriticalCareMinutes.com
http://www.criticalcareminutes.com/

Documents

An Update on Procedural Sedation