An Update on Procedural Sedation

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An Update on Procedural Sedation

  1. 1. 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
  2. 2. primum non nocere First, Do No Harm
  3. 3. Objectives • Background • “Continuum of Sedation” • New JCAHO Standards • Patient Selection & Credentialing • Process and Quality Improvement • Final Thoughts
  4. 4. Objectives • Background • “Continuum of Sedation” • New JCAHO Standards • Patient Selection & Credentialing • Process and Quality Improvement • Final Thoughts
  5. 5. The Old “Conscious Sedation” • Inconsistent pre- procedure screening • NO requirement for documentation • NO major monitoring standards • NO quality or performance evaluation requirement • NO credentialing required
  6. 6. Goals of Procedural Sedation • Patient Comfort o Reduce Pain o Reduce Anxiety • Patient Safety o Maintain cardiopulmonary function o Minimize and manage related complications • Improve Efficiency o Optimize procedural conditions • Adequate Recovery o Patient returned to pre-procedural functional and physiologic level
  7. 7. 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.
  8. 8. Dangers of Sedation • Bailey et al. o Healthy Volunteers o Given midazolam, fentanyl or both o 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
  9. 9. Dangers of Sedation • Iber et al. 1 o 10 pts developed Apnea or Cardiopulmonary Arrest during or following endoscopy • Arrowsmith et al. 2 o ASGE/FDA Collaborative Study o >21K GI endoscopy procedures o “Serious” CV complications 5.4 / 1000 • Vargo et al. 3 o 49 pts upper endoscopy o 57% with 54 episodes of apnea (>30 sec) o 50% with hypoxemia 1IberFL et al. J Clinical Gastroenterology 1992; 14:109–13 2Arrowsmith et al. Gastrointestinal Endoscopy, 1991; 37:421–7 3Vargo et al. Gastrointestinal Endoscopy 55:826-831, 2002
  10. 10. 98,000 Preventable Deaths $17 billion to $29 billion cost
  11. 11. • MAC claims o > 40% with death or brain damage • Most common injury o Respiratory depression from over-sedation • Median Payment o $240,000
  12. 12. 44% judged to be PREVENTABLE By Better Monitoring (pulse oximetry, capnography, improved vigilance, or audible alarms)
  13. 13. Mainstream Media
  14. 14. 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
  15. 15. Possible Solutions ? • Provider Education and Training • Patient Selection • Improved Monitoring • Increased VIGILANCE
  16. 16. Objectives • Background • “Continuum of Sedation” • New JCAHO Standards • Patient Selection & Credentialing • Process and Quality Improvement • Final Thoughts
  17. 17. 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 Moderate Sedation Deep Sedation / General Anesthesia Sedation / Analgesia Analgesia (“Anxiolysis”) (“Conscious Sedation”) Responsiveness Normal Purposeful* Purposeful* Unarousable, even response to response to verbal response following with painful verbal or tactile repeated or painful stimulus stimulation stimulation stimulation Airway Unaffected No intervention Intervention may Intervention often required be required required Spontaneous Unaffected Adequate May be inadequate Frequently Ventilation inadequate Cardiovascular Unaffected Usually maintained Usually maintained May be impaired Function * Reflex withdrawal from a painful stimulus is NOT considered a purposeful response
  18. 18. 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 Deep Sedation / (“Conscious Sedation”) Analgesia Responsiveness Purposeful* response to verbal Purposeful* response or tactile stimulation following repeated or painful stimulation Airway No intervention required Intervention may be required Spontaneous Adequate May be inadequate Ventilation Cardiovascular Usually maintained Usually maintained Function * Reflex withdrawal from a painful stimulus is NOT considered a purposeful response
  19. 19. 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
  20. 20. 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
  21. 21. 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 tunneled)
  22. 22. 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 • Multiple trauma patients in the ER
  23. 23. 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 o (357 with direct-linkage related evidence) EVIDENCE BASED GUIDELINES
  24. 24. As the details became more and more transparent …
  25. 25. The Joint Commission was watching…
  26. 26. …and after thorough survey, inspection and review…
  27. 27. Objectives • Background • “Continuum of Sedation” • New JCAHO Standards • Patient Selection & Credentialing • Process and Quality Improvement • Final Thoughts
  28. 28. 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)
  29. 29. “Comparable Care” Mandate “There must be no decrement in the care delivered to patients during their entire continuum of care within the hospital.”
  30. 30. 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 those utilized for MAC delivered by qualified anesthesia providers in the OR.
  31. 31. JCAHO Standards • Assessment of Patients (PE) • Care of Patients (TX) • Improving Organizational Performance (PI)
  32. 32. JCAHO Standards • Assessment of Patients (PE) o PE.1.8.1  Any patient for whom moderate or deep sedation or anesthesia is contemplated receives a pre-sedation or pre- anesthesia assessment o PE.1.8.2  Before anesthesia, the patient is determined to be an appropriate candidate for anesthesia. o PE.1.7.3  The patient is re-evaluated immediately before anesthesia induction o 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
  33. 33. JCAHO Standards • Care of Patients (TX) o TX.2.0  Moderate or deep sedation and anesthesia are provided by qualified individuals o 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. o TX.2.1.1  Each patient's moderate or deep sedation and anesthesia care is planned. o 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
  34. 34. JCAHO Standards • Care of Patients (TX) – contd. o TX.2.  Each patient's physiological status is monitored during sedation or anesthesia administration o TX.2.4  The patient's post-procedure status is assessed on admission to and before discharge from the post-sedation or post- anesthesia recovery area o TX.2.4.1  Patients are discharged from the post-sedation or post- anesthesia recovery area and the organization by a qualified LIP or according to criteria approved by the medical staff. o TX.3.5.5  Emergency medications are consistently available, controlled and secure in the pharmacy and patient care areas Cohen et al. ASA Newsletter. May 2001
  35. 35. JCAHO Standards • Improving Organizational Performance (PI) o PI.4.  Data are systematically aggregated and analyzed on an ongoing basis o PI.4.2.  The organization compares its performance over time and with other sources of information o PI.4.3.  Undesirable patterns or trends in performance and sentinel events are intensively analyzed . o PI.4.4.  The organization identifies changes that will lead to improved performance and reduce sentinel events Cohen et al. ASA Newsletter. May 2001
  36. 36. What this means for the Provider?
  37. 37. Objectives • Background • “Continuum of Sedation” • New JCAHO Standards • Patient Selection & Credentialing • Process and Quality Improvement • Final Thoughts
  38. 38. Patient Selection • Planned Procedure o Associated physiologic derangements • Patient’s Medical Status o CoMorbid Conditions o Preoperative Status is Optimized o Airway Exam o NPO Guidelines • Intended Level of Sedation/Analgesia o Must be decided in advance o Moderate vs. Deep
  39. 39. Pre-Procedure Assessment • Focused H&P o Summary of Patient Current Condition o Review Medications and Allergies o Review of Co-Morbid Diseases o Previous adverse rxn to sedation/anesthesia o Last PO Intake (time and nature) o Cardiac, Pulmonary and Airway exam • MUST be reviewed immediately prior to procedure for any changes
  40. 40. ASA Classification E: after the Class would represent an emergency
  41. 41. 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.
  42. 42. Mallampati Score
  43. 43. Mallampati Score OTHER RELAVANT HISTORY: H/O Snoring Thick Neck Difficulty with Neck ROM MAY BE HIGH RISK FOR AIRWAY DIFFICULTIES
  44. 44. High Risk Patients • Extremes of Age • Pregnancy • Severe cardiac, • H/o drug abuse or pulmonary, renal, EtOH abuse or hepatic disease • H/o difficulty with (ASA class ≥ III) sedation or • Potential difficult anesthesia intubation • DEEP Sedation is (MP score ≥ III) planned
  45. 45. High Risk Patients • Extremes of Age • Pregnancy • Severe cardiac, • H/o drug abuse or pulmonary, renal, EtOH abuse or hepatic disease • H/o difficulty with (ASA class ≥ III) sedation or • Potential difficult anesthesia intubation • DEEP Sedation is (MP score ≥ III) planned IF ONE or MORE of these risk factors And DEEP sedation planned CONSIDER GETTING ANESTHESIOLOGY INVOLVED
  46. 46. Informed Consent • MUST INCLUDE: o Consent for the Procedure o Consent for the Planned Sedation / Analgesia o R / B / A / P for BOTH must be done
  47. 47. Staffing Requirements • Two Licensed Professionals Required o Proceduralist  Licensed Independent Practitioner o Qualified Assistant (Monitoring Physician or RN)  “Supervised Sedation Professional”1 • Appropriately Credentialed o Different for Moderate and Deep Sedation 1ASA Guidelines. October 2006
  48. 48. 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
  49. 49. Registered Nurse Credentials INSTITUTIONAL CREDENTIALING REQUIREMENTS + • Supervised by LIP (Moderate Sedation Only) • Pharmacology o Age- and weight- related dosage, reversals • Monitoring o Pulse oximetry, Cardiac monitors • Level of consciousness assessment • Pain assessment • Arrhythmia recognition • Basic Airway management • ***Recognition of Deep Sedation***
  50. 50. 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
  51. 51. 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
  52. 52. 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)
  53. 53. Physician Credentialing • ER, ICU excluded • Competency and Training in: o Oxygen delivery systems o Basic cardiovascular physiology o Pharmacology of sedatives and reversal agents o Understanding and knowledge of required and emergency equipment o KNOW HOW TO CALL FOR HELP !
  54. 54. Moderate Sedation • Sedation/Analgesia Training and Privileging o Institution dependent (ex. Online or Live Sedation Course followed by a quiz) o ***Recognition of Deep Sedation*** • Basic Resuscitative Techniques o BCLS (renew every years) • Demonstrate proficiency in airway management with bag-mask ventilation
  55. 55. Deep Sedation
  56. 56. Deep Sedation Requirements for Moderate Sedation + • Advanced Resuscitative Techniques o 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)
  57. 57. 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) o Does not replace examination of patient • Emergency equipment o Suction o Crash Cart o Airway Rescue Equipment
  58. 58. 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
  59. 59. Procedural Sedation Record Performed by a Dedicated Qualified Assistant • Document Vitals at regular intervals o Moderate sedation (q 10 min) o Deep sedation (q 5 min) • Pain and Sedation Scoring System o Oxygen Saturation and Respiratory Rate o Level of consciousness (ex. Ramsey Scale) o Verbal and visual exam by monitoring assistant • Airway Manipulation Interventions o Chin lift, Jaw thrust, adjunct airway, MV, etc. o May assist in post procedure audit
  60. 60. Recovery • Standards of Monitoring continue • Appropriate staff available • Documentation continues • In-patients o must return to baseline function and physiological status prior to return to RNF • Out-patients o alert and oriented o stable vital signs o baseline ambulation status o pain and nausea well controlled
  61. 61. Objectives • Background • “Continuum of Sedation” • New JCAHO Standards • Patient Selection & Credentialing • Process and Quality Improvement • Final Thoughts
  62. 62. Quality Improvement • Hospital Quality Improvement o Certification of Procedure Sedation Site o Oversight of sedation practice and evaluation of patient outcomes o 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
  63. 63. Quality Improvement • Department Quality Improvement o Applies to each department providing Moderate Sedation o Systematically gather and analyze data on a continuous basis o Establish Department Specific Quality Markers and Thresholds o Develop Quality Reports that are reviewed by Hospital QI o Perform regular reviews
  64. 64. 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
  65. 65. Objectives • Background • “Continuum of Sedation” • New JCAHO Standards • Patient Selection & Credentialing • Process and Quality Improvement • Final Thoughts
  66. 66. 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
  67. 67. Key Resources • Continuum of Depth of Sedation • ASA Sedation Guidelines for Non- Anesthesiologists
  68. 68. Pass the Survey! • CREDENTIALING MUST BE MAINTAINED! • EVERY PATIENTS PROCEDURAL SEDATION PLAN SHOULD BE INDIVIDUALIZED o Avoid “COOKBOOK” Techniques
  69. 69. Pass the Survey • Quality and Process Improvement Strategies employed across the Institution • Compliance with JCAHO “Comparable Care Mandate” PRIMARY GOAL: PATIENT SAFETY
  70. 70. Conclusion Procedural Sedation is extremely Safe and Effective when performed on well selected, adequately informed patients, by appropriately trained, credentialed, and well supported providers.
  71. 71. ADEQUATE PREPARATION LEADS TO A SAFE, EFFECTIVE AND SATISFACTORY EXPERIENCE
  72. 72. QUESTIONS ? Today’s Presentation and supporting documents available online: www.CriticalCareMinutes.com

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