Off-site Anesthesia: New Challenges

1. Off-site Anesthesia: New Challenges Pattricia S Klarr, M.D. University of Michigan

2. What is the largest thing an endoscopist can remove from an anesthetized patient?

3. …A Surgeon!

4. Goals and Objectives • -compare providing anesthesia in the endoscopy suite vs the operating room • -review procedure types and anesthetic considerations • -discuss evolution of anesthetic presence and effect of cost and efficiency • -discuss impact of technology on the future

5. Introduction • NORA: • Non • Operating • Room • Anesthesia • Also known as “Remote, offsite”

7. Challenges Not working with surgeons and operating room personnel Lack of understanding of respective processes Team building Equipment needs/space requirements

8. If the relationship of surgeons with anesthesia is a marriage without love… Then working with gastroenterologists is kind of like this…… ….but it doesn’t have to be.

9. How did we get here? Vast majority of endoscopic procedures can be done with (nurse) sedation What has evolved is improvement of technology and acuity of patients

10. NORA Rotation “…doing 5 straight days of the MPU is a bit much. It’s not that the hours are bad, it’s just that the pace and workflow down here can be pretty frustrating, and after a couple of days of it, I feel like I need to go back to an OR or I may lose my mind.”

11. NORA GI anesthesia is like regular anesthesia because: • Standardized monitoring • Preprocedure evaluation and preparation

12. It’s different because… • Access to specialized equipment is limited • Less support from nearby anesthetic colleagues

13. Other challenges • -inefficient scheduling • -lack of access to medical records-open access patients • -equipment upkeep/stocking of supplies • -poor physical lay out • -tech and nursing unfamiliar with anesthesia procedures • -unfamiliarity with procedures/proceduralists

14. Conditions where anesthesia support is indicated • Uncooperative/combative patient • Severe GERD • ASA>3 • OSA, morbid obesity • Known/suspected difficult intubation • Known difficult to sedate • Chronic pain patients

15. Anesthesia support for: • Prolonged, difficult or painful procedures • Abnormal body habitus making positioning difficult • Extremes of ages

16. Common Endoscopic Procedures • -Colonoscopy • -Esophagogastroduodenoscopy (EGD) • -Endoscopic Ultrasonography (EUS) • -Endoscopic Retrograde Cholangiopancreatography (ERCP) • -Double balloon enteroscopy (DBE) • -Endoscopic Mucosal Resection (EMR)

17. Mostly done with light to moderate sedation Deep sedation indicated with Uncooperative patient Tolerant to pain/antianxiety medication ASA>3 Anesthetic choices include midazolam/fentanyl and or propofol

18. EGD Moderate to deep sedation Consider intubation with severe reflux, aspiration risk

19. EUS Ultrasound probe larger May require deep sedation to general anesthesia -better yield with FNA with deeper anesthetic

20. ERCP Weigh risk versus benefits of deep sedation and intubating patient. Patients are prone GERD is common comorbidity

21. Double Balloon Endoscopy General anesthesia for oral entry Improves visualization of entire GI tract.

22. Endoscopic Mucosal Resection Removes mucosal lesions while preserving the submucosa and deeper layers. -diagnosis and treatment of superficial lesions, precancerous such as Barrett's -can be curative early superficial cancers of GI tract Deep vs. General Anesthesia

23. Risks Associated with GI Endoscopy • -Hemodynamic instability • -elderly with limited cardiac reserve • -dehydrated after prep • -vagal response to GI distention • -Aspiration risk • -Airway access • -shared airway

24. Closed Claims NORA Findings • 24 NORA Claims from 1990-2001 • -half were from GI Suite • -most were MAC • -7of the 9 respiratory NORA events were GI • 4 of the 7 were during ERCP

25. Respiratory Events • -half respiratory events deemed preventable with better monitoring • -respiratory complications associated with • -nonvigilance • -inappropriate anesthetic choice • -untrained staff • -poor documentation

26. Further Findings • Inadequate oxygenation/ventilation was most common damaging event • -oversedation • -lack of monitoring specifically 02 sat monitor and capnography • -Reviewers judged care as substandard in 54% of cases and preventable with better monitoring in 32% of cases

27. Lessons Learned/Recommendations • Standard monitors for all anesthesia locations • Capnography and pulse oximitry can prevent respiratory complications • Supplemental oxygen may disguise hypoventilation if capnogram not used.

28. Safety Rules in Anesthesia! • -Reliable • -standardization of care • -minimum monitoring standards • capnography/pulse oximitry

29. Reliability • -continuous learning • -just and fair culture • individuals are appreciated and accountable • -enthusiasm for teamwork • -debriefing • -support of leadership • -effective flow of information

30. Have anesthesia machine… Will Travel OK, we’re needed. We are safe and reliable. They are going to love us in the endoscopy suite now, right?

31. Propofol • Increase in colonoscopy for cancer screening • Propofol sedation in many ways superior to fentanyl / midazolam • rapid turn over = more volume • Very safe for use in moderate sedation

32. Pesky FDA Warning Label • “For general anesthesia or MAC sedation, (propofol) should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure. “

33. “Much of this debate, during a time of increasing health care costs and decreasing physician reimbursements, seems to reflect economic rather than clinical concerns” Douglas K Rex in The science and politics of propofol, Am J. Gastroenterology 2004 Gastroenterology view

34. “(T)his is purely a move by gastroenterologists related to reimbursement. It’s not for improved patient safety; it’s not for improved patient outcomes”. Gervirtz, MD, MPH, Gastroendonews, May 2005 Anesthesia Response

36. Revenue from Endoscopy

39. GastroenterologistDouglas Rex, M.D • “Trained Registered Nurses/endoscopy teams can administer propofol safely for endoscopy” • Gastroenterology 2005

40. Oral Surgeon Weighs In • -passing an ACLS course every 2 years doesn’t make you skilled to handle BMV an unconscious patient in laryngospasm • -Joel Weaver, DDS, PhD • Anesthesia Progress, Summer 2006

41. Endoscopist-directed Administration of Propofol: A Worldwide Safety Experience Douglas K Rex, et al*

42. Findings: • In almost 650,000 cases of endoscopist directed propofol sedation cases world-wide, there were only 15 major complications: • 11 need for intubation • 4 deaths • 0 permanent neurological injuries

43. Conclusion • Paraphrasing: • 1. Endoscopist directed propofol administration is safe. • 2. Anesthesia providers have higher costs relative to potential benefits

44. Oh, by the way… • -one of the limitations of the paper was “the reliability of the data depended on the self-reporting by the individual participating centers…” • -and about the co-author, John A. Walker, his conflict disclosure includes this: • CEO of Dr. NAPS

45. From the Internet • Dr. NAPS Inc. is a company that educates and trains RNs and physicians in the safe use of Propofol for procedural sedation. We will assist you in integrating the use of NAPS (nurse administered Propofol sedation) into your practice setting efficiently and effectively. John Walker, CEO*

46. Gastroenterology Wants In • Position statement: nonanesthesiologist administratration of propofol for GI endoscopy: “…with adequate training, physician-supervised nurse administration of propofol can be done safely and effectively” joint statement of AASLD, ACG, AGA, and ASGE 2009

47. The fight over propofol: Michael Jackson death June 2009 CMS guidelines 2010..propofol is only indicated for general anesthesia, MAC and for the sedations of the mechanically-ventilated patients. -Anesthesia Department is responsible for oversite

48. FDA deny ACG request 8/10 • -arguments not compelling • -supports CMS requirement for anesthesia training if use propofol

49. FDA-restriction • Off label use of propfol opened up liability issues for gastroenterologists • bye-bye Dr NAPS • European instruction still available

50. Dr. Cohen responds: “I believe the vast majority of endoscopists target moderate sedation, not deep. Therefore, FDA’s concerns about the risk of deep sedation and general anesthesia are unwarranted.”