An Update On Procedural Sedation

An Update on Procedural Sedation A Primer on the Rules!

Shiva Birdi M.D. Staff Anesthesiologist and Intensivist Anesthesiology Institute Cleveland Clinic May 14, 2009

primum non nocere First, Do No Harm

Objectives Background “Continuum of Sedation” New JCAHO Standards Patient Selection & Credentialing Process and Quality Improvement Final Thoughts

Objectives Background “Continuum of Sedation” New JCAHO Standards Patient Selection & Credentialing Process and Quality Improvement Final Thoughts

The Old “Conscious Sedation” Inconsistent preprocedure screening NO requirement for documentation NO major monitoring standards NO quality or performance evaluation requirement NO credentialing required

Goals of Procedural Sedation Patient Comfort Reduce Pain Reduce Anxiety

Patient Safety Maintain cardiopulmonary function Minimize and manage related complications

Improve Efficiency Optimize procedural conditions

Adequate Recovery Patient returned to pre-procedural functional and physiologic level

A Bit of History Midazolam (Versed®) introduced in United States in mid 1980s

86 Deaths in first 5 years of use Majority related to procedural sedation 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.

Dangers of Sedation Bailey et al. Healthy Volunteers Given midazolam, fentanyl or both Hypoxemia (92%) and Apnea (50%) combination of midazolam and fentanyl

Reported to Department of Health and Human Services Bailey et al. Anesthesiology. 73(5):826-830, Nov 1990

Dangers of Sedation Iber et al.

1

10 pts developed Apnea or Cardiopulmonary Arrest 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) Iber FL et al. J Clinical Gastroenterology 1992; 14:109–13 50% with hypoxemia Arrowsmith et al. Gastrointestinal Endoscopy, 1991; 37:421–7 1 2

3Vargo

et al. Gastrointestinal Endoscopy 55:826-831, 2002

98,000 Preventable Deaths $17 billion to $29 billion cost

MAC claims > 40% with death or brain damage

Most common injury Respiratory depression from over-sedation

Median Payment $240,000

44% judged to be PREVENTABLE By Better Monitoring (pulse oximetry, capnography, improved vigilance, or audible alarms)

Mainstream Media

Dangers of Sedation Airway Disaster / Aspiration Respiratory Depression Cardiovascular Complications Paradoxical Response to sedation Medication Related Events Inadequate Sedation / Movement Nausea and Vomiting Patient Dissatisfaction

Possible Solutions ? Provider Education and Training Patient Selection Improved Monitoring Increased VIGILANCE

Objectives Background

“Continuum of Sedation” New JCAHO Standards Patient Selection & Credentialing Process and Quality Improvement Final Thoughts

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)

Minimal Sedation (“Anxiolysis”)

Moderate Sedation / Analgesia (“Conscious Sedation”)

Deep Sedation / Analgesia

General Anesthesia

Responsiveness

Normal response to verbal stimulation

Purposeful* response to verbal or tactile stimulation

Purposeful* response following repeated or painful stimulation

Unarousable, even with painful stimulus

Airway

Unaffected

No intervention required

Intervention may be required

Intervention often required

Spontaneous Ventilation

Unaffected

Adequate

May be inadequate

Frequently inadequate

Cardiovascular Function

Unaffected

Usually maintained

Usually maintained

May be impaired

* Reflex withdrawal from a painful stimulus is NOT considered a purposeful response

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)

Moderate Sedation / Analgesia (“Conscious Sedation”)

Deep Sedation / Analgesia

Responsiveness Purposeful* response to verbal or tactile stimulation

Purposeful* response following repeated or painful stimulation

Airway

No intervention required

Intervention may be required

Spontaneous Ventilation

Adequate

May be inadequate

Cardiovascular Function

Usually maintained

Usually maintained

* Reflex withdrawal from a painful stimulus is NOT considered a purposeful response

Moderate Sedation/Analgesia The Old “Conscious Sedation” Patient RESPONDS PURPOSEFULLY to verbal commands/light stimulation NO airway manipulation required Spontaneous ventilation maintained Cardiovascular function usually maintained

Deep Sedation/Analgesia Patient not easily aroused Patient RESPONDS PURPOSEFULLY to repeated or painful stimulation Airway manipulation MAY BE required Spontaneous ventilation MAY BE inadequate Cardiovascular function usually maintained

Brief List of Procedures Endoscopic Examinations (GI) Vascular and Cardiac Catheterizations Cardioversion and EPS procedures Burn/Wound Debridement Foreign Body Removal Complex Laceration Repair Fracture Reduction / Orthopedic Diagnostic Procedures (ex. MRI/CT) Tube Thoracostomy Central Line Placements (including

Some Exclusions Preoperative medications Patient controlled analgesia Post-operative or labor analgesia Pain Management (dressings, burns or angina) Sedation in the intensive care unit Sedation for treatment of insomnia Anxiolysis (single dose) Drug or alcohol withdrawal or prophylaxis Treatment of seizure disorders

Practice Guidelines for Sedation and Analgesia by Non-Anesthesiologists Approved by ASA, October 17, 2001 10 task force members (Dr. Zuccaro – CCF) 51 consultants from 17 specialties surveyed Based on review of 1876 articles over 44 year period (357 with direct-linkage related evidence) EVIDENCE BASED GUIDELINES

As the details became more and more transparent …

The Joint Commission was watching…

…and after thorough survey, inspection and review…

Objectives Background “Continuum of Sedation”

New JCAHO Standards Patient Selection & Credentialing Process and Quality Improvement Final Thoughts

STANDARDS UPDATED Adopted ASA Evidence Based Guidelines and Depth of Sedation Continuum Joint Commission on Accreditation of Healthcare Organizations: "Standards and Intents for Sedation and Anesthesia Care," in Revisions to Anesthesia Care Standards, Comprehensive Accreditation Manual for Hospitals. Oakbrook Terrace, Ill., Joint Commission on Accreditation of Healthcare Organizations, 2001. (updated 2004)

“Comparable Care” Mandate

“There must be no decrement in the care delivered to patients during their entire continuum of care within the hospital.”

Bottom Line All “conscious sedation” areas (OR and non-OR) must have processes (pre-sedation assessment, intraprocedure monitoring, discharge criteria), facilities, equipment, and personnel similar to those utilized for MAC delivered by qualified anesthesia providers in the OR.

JCAHO Standards Assessment of Patients (PE) Care of Patients (TX) Improving Organizational Performance (PI)

JCAHO Standards Assessment of Patients (PE) PE.1.8.1 Any patient for whom moderate or deep sedation or anesthesia is contemplated receives a pre-sedation or pre-anesthesia assessment

PE.1.8.2 Before anesthesia, the patient is determined to be an appropriate candidate for anesthesia.

PE.1.7.3 The patient is re-evaluated immediately before anesthesia induction

PE.1.8.4 The patient's postoperative status is assessed on admission to and discharge from the post-anesthesia recovery area Cohen et al. ASA Newsletter. May 2001

JCAHO Standards Care of Patients (TX) TX.2.0 Moderate or deep sedation and anesthesia are provided by qualified individuals

TX.2.1 A pre-sedation or pre-anesthesia assessment is performed for each patient before beginning moderate or deep sedation and before anesthesia induction.

TX.2.1.1 Each patient's moderate or deep sedation and anesthesia care is planned.

TX.2.2 Sedation and anesthesia options and risks are discussed with the patient and family prior to administration Cohen et al. ASA Newsletter. May 2001

JCAHO Standards Care of Patients (TX) – contd. TX.2. Each patient's physiological status is monitored during sedation or anesthesia administration

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

TX.2.4.1 Patients are discharged from the post-sedation or postanesthesia recovery area and the organization by a qualified LIP or according to criteria approved by the medical staff.

TX.3.5.5 Emergency medications are consistently Cohenavailable, et al. ASA Newsletter. May 2001 controlled and secure in the pharmacy and patient care

JCAHO Standards Improving Organizational Performance (PI) PI.4. Data are systematically aggregated and analyzed on an ongoing basis

PI.4.2. The organization compares its performance over time and with other sources of information

PI.4.3. Undesirable patterns or trends in performance and sentinel events are intensively analyzed .

PI.4.4. Cohen et al. ASA May 2001 The organization identifies changes that willNewsletter. lead to

What this means for the Provider?

Objectives Background “Continuum of Sedation” New JCAHO Standards

Patient Selection & Credentialing Process and Quality Improvement Final Thoughts

Patient Selection Planned Procedure Associated physiologic derangements

Patient’s Medical Status CoMorbid Conditions Preoperative Status is Optimized Airway Exam NPO Guidelines

Intended Level of Sedation/Analgesia Must be decided in advance

Pre-Procedure Assessment Focused H&P Summary of Patient Current Condition Review Medications and Allergies Review of Co-Morbid Diseases Previous adverse rxn to sedation/anesthesia Last PO Intake (time and nature) Cardiac, Pulmonary and Airway exam

MUST be reviewed immediately prior to procedure for any changes

ASA Classification

E: after the Class would represent an emergency

ASA Classification

ASA Closed Claims Study (for sedation)1 age 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.

Mallampati Score

Mallampati Score OTHER RELAVANT HISTORY: H/O Snoring Thick Neck Difficulty with Neck ROM

MAY BE HIGH RISK FOR AIRWAY DIFFICULTIES

High Risk Patients Extremes of Age Severe cardiac, pulmonary, renal, or hepatic disease (ASA class ≥ III) Potential difficult intubation (MP score ≥ III)

Pregnancy H/o drug abuse or EtOH abuse H/o difficulty with sedation or anesthesia DEEP Sedation is planned

High Risk Patients Extremes of Age Severe cardiac, pulmonary, renal, or hepatic disease (ASA class ≥ III) Potential difficult intubation (MP score ≥ III)

Pregnancy H/o drug abuse or EtOH abuse H/o difficulty with sedation or anesthesia DEEP Sedation is planned

IF ONE or MORE of these risk factors And DEEP sedation planned CONSIDER GETTING ANESTHESIOLOGY INVOLVED

Informed Consent MUST INCLUDE: Consent for the Procedure Consent for the Planned Sedation / Analgesia R / B / A / P for BOTH must be done

Staffing Requirements Two Licensed Professionals Required Proceduralist Licensed Independent Practitioner

Qualified Assistant (Monitoring Physician or RN) “Supervised Sedation Professional”1

Appropriately Credentialed Different for Moderate and Deep ASA Guidelines. October 2006 Sedation 1

Ohio Board of Nursing ( July 2007) RN (not CRNA) cannot engage in administration of medications that induce DEEP SEDATION or GENERAL ANESTHESIA RN cannot engage in activities that divert attention away from the patient www.nursing.ohio.gov

Registered Nurse Credentials INSTITUTIONAL CREDENTIALING REQUIREMENTS + Supervised by LIP (Moderate Sedation Only) Pharmacology Age- and weight- related dosage, reversals

Monitoring Pulse oximetry, Cardiac monitors

Level of consciousness assessment Pain assessment Arrhythmia recognition Basic Airway management ***Recognition of Deep Sedation***

Sedation Practice (JCAHO and ASA Guideline) Understand Sedation Continuum Difficult to predict individual patient response to sedation MUST be able to “RESCUE” patient from next level of sedation MODERATE • DEEP DEEP • GA

RESCUE and RETURN (JCAHO and ASA Guideline) Sedation Practitioner must be able to RESCUE a patient one level above the intended level of sedation After RESCUE the patient is RETURNED to the original intended level of sedation

Physician Credentialing “Each organization is free to define how it will determine that the individuals are able to perform the rescue” (JCAHO Feb, 2009) “Physicians administering or supervising moderate or deep sedation/analgesia should have appropriate education and training” (ACS ST-46 April 2004) “Only physicians…with adequate training, education and licensure to administer moderate sedation should supervise…” (ASA Statement October 2006)

Physician Credentialing ER, ICU excluded Competency and Training in: Oxygen delivery systems Basic cardiovascular physiology Pharmacology of sedatives and reversal agents Understanding and knowledge of required and emergency equipment KNOW HOW TO CALL FOR HELP !

Moderate Sedation Sedation/Analgesia Training and Privileging Institution dependent (ex. Online or Live Sedation Course followed by a quiz)

***Recognition of Deep Sedation***

Basic Resuscitative Techniques BCLS (renew every years)

Demonstrate proficiency in airway management with bag-mask ventilation

Deep Sedation

Deep Sedation Requirements for Moderate Sedation + Advanced Resuscitative Techniques ACLS, ATLS (renew every 2 years)

Demonstrate ability to manage associated complications including slipping into General Anesthesia Advanced airway management skills including use of airway assist devices and manage compromised airways (ex. Airway workshop offered at institution)

Equipment Oxygen Supply Pulse Oximetry Blood Pressure *EKG* (as indicated for at risk patient in moderate 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 Supplemental oxygen decreases incidence of hypoxemia Adequate OXYGENATION does not mean adequate VENTILATION REVERSAL agents (Naloxone, Flumazenil) must be available IV access must be maintained throughout the procedure and recovery phase

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 Standards of Monitoring continue Appropriate staff available Documentation continues In-patients must return to baseline function and physiological status prior to return to RNF

Out-patients alert and oriented stable vital signs baseline ambulation status pain and nausea well controlled

Objectives Background “Continuum of Sedation” New JCAHO Standards Patient Selection & Credentialing

Process and Quality Improvement Final Thoughts

Quality Improvement Hospital Quality Improvement Certification of Procedure Sedation Site Oversight of sedation practice and evaluation of patient outcomes Monitor and Identify System Failures to Reduce Incidence of Sentinal Events* *A sentinel event is an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof . *Joint Commission Standards

Quality Improvement Department Quality Improvement Applies to each department providing Moderate Sedation Systematically gather and analyze data on a continuous basis Establish Department Specific Quality Markers and Thresholds Develop Quality Reports that are reviewed by Hospital QI Perform regular reviews

Examples of Quality Markers ANY need to Rescue patients from unintended deeper level of sedation ANY usage of airway manipulation maneuvers ANY major change in VS (Sat/BP) ANY major cardiopulmonary event ANY use of reversal agents ANY prolonged recovery phase

Objectives Background “Continuum of Sedation” New JCAHO Standards Patient Selection & Credentialing Process and Quality Improvement

Final Thoughts

Final Thoughts … PATIENT SELECTION IS CRITICAL Anesthesia involvement for patients at high risk for sedation complications Titration of sedative / analgesics Adequate oxygenation DOES NOT equal adequate ventilation EARLY RECOGNITION OF DEEPER THAN INTENDED SEDATION

Key Resources Continuum of Depth of Sedation ASA Sedation Guidelines for NonAnesthesiologists

Pass the Survey! CREDENTIALING MUST BE MAINTAINED! EVERY PATIENTS PROCEDURAL SEDATION PLAN SHOULD BE INDIVIDUALIZED Avoid “COOKBOOK” Techniques

Pass the Survey Quality and Process Improvement Strategies employed across the Institution Compliance with JCAHO “Comparable Care Mandate”

PRIMARY GOAL: PATIENT SAFETY

Conclusion Procedural Sedation is extremely Safe and Effective when performed on well selected, adequately informed patients, by appropriately trained, credentialed, and well supported providers.

ADEQUATE PREPARATION LEADS TO A SAFE, EFFECTIVE AND SATISFACTORY EXPERIENCE

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