Off-site Anesthesia: New Challenges

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Off-site Anesthesia New Challenges

• Pattricia S Klarr, M.D.
• University of Michigan

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What is the largest thing an endoscopist can
remove from an anesthetized patient?
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A Surgeon!
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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

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Introduction

• NORA
• Non
• Operating
• Room
• Anesthesia
• Also known as Remote, offsite

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Challenges

1. Not working with surgeons and operating room
   personnel
2. Lack of understanding of respective processes
3. Team building
4. Equipment needs/space requirements

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If the relationship of surgeons with anesthesia
is a marriage without love

• Then working with gastroenterologists is kind of
  like this

.but it doesnt have to be.
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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

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NORA Rotation

• doing 5 straight days of the MPU is a bit much.
  Its not that the hours are bad, its 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.

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NORA GI anesthesia is like regular anesthesia
because

• Standardized monitoring
• Preprocedure evaluation and preparation

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Its different because

• Access to specialized equipment is limited
• Less support from nearby anesthetic colleagues

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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

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Conditions where anesthesia support is indicated

• Uncooperative/combative patient
• Severe GERD
• ASAgt3
• OSA, morbid obesity
• Known/suspected difficult intubation
• Known difficult to sedate
• Chronic pain patients

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Anesthesia support for

• Prolonged, difficult or painful procedures
• Abnormal body habitus making positioning
  difficult
• Extremes of ages

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Common Endoscopic Procedures

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

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1. Mostly done with light to moderate sedation
2. Deep sedation indicated with
3. Uncooperative patient
4. Tolerant to pain/antianxiety medication
5. ASAgt3
6. Anesthetic choices include midazolam/fentanyl
   and or propofol

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EGD

1. Moderate to deep sedation
2. Consider intubation with severe reflux,
   aspiration risk

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EUS

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

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ERCP

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

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Double Balloon Endoscopy

1. General anesthesia for oral entry
2. Improves visualization of entire GI tract.

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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

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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

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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

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Respiratory Events

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

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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

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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.

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Safety Rules in Anesthesia!

• -Reliable
• -standardization of care
• -minimum monitoring standards
• capnography/pulse oximitry

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Reliability

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

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Have anesthesia machine

• Will Travel
• OK, were needed. We are safe and reliable.
• They are going to love us in the endoscopy suite
  now, right?

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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

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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.

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Gastroenterology view

• 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

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Anesthesia Response

• (T)his is purely a move by gastroenterologists
  related to reimbursement. Its not for improved
  patient safety its not for improved patient
  outcomes.
• Gervirtz, MD, MPH, Gastroendonews, May 2005

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Revenue from Endoscopy
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GastroenterologistDouglas Rex, M.D

• Trained Registered Nurses/endoscopy teams can
  administer propofol safely for endoscopy
• Gastroenterology 2005

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Oral Surgeon Weighs In

• -passing an ACLS course every 2 years doesnt
  make you skilled to handle BMV an unconscious
  patient in laryngospasm
• -Joel Weaver, DDS, PhD
• Anesthesia Progress, Summer 2006

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Endoscopist-directed Administration of Propofol
A Worldwide Safety Experience

• Douglas K Rex, et al

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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

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Conclusion

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

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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

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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

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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

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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

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FDA deny ACG request 8/10

• -arguments not compelling
• -supports CMS requirement for anesthesia training
  if use propofol

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FDA-restriction

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

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Dr. Cohen responds

• I believe the vast majority of endoscopists
  target moderate sedation, not deep. Therefore,
  FDAs concerns about the risk of deep sedation
  and general anesthesia are unwarranted.

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Cote study

• Predictors of complications during endoscopy
• -male gender
• -high BMI
• -ASA score of 3 or higher
• -overall, deep sedation with propofol is safe for
  advanced endoscopic cases

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Cote

• The vast majority of MAC cases (87.3) could be
  considered slipping into a state of general
  anesthesia.

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Metzner and Domino 2010

• Many studies arent blinded are biased and have
  conflict of interest
• -reliable studies are hampered by low incidence
  of severe adverse events, are expensive and
  difficult to perform

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NORA Near Miss Causes
Anesthesiology News, March, 2013
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Ootaki Paper 2012

• -retrospective analysis of 371 patients
• -compared yield of EUS-FNA of solid pancreatic
  masses
• 73 vs. 83 diagnostic with GA
• -believe better patient cooperation attributed to
  improvement
• -cost impact?
• Ootaki, et al, Anesthesiology 2012 1171044-50

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Technology to the Rescue?
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From GI private practitioners

• FDA approval of (Sedasys) does not make patient
  care dummy-proof or safest for a given patient,
  because in the event of a misadventure, a rescue
  expert is not immediately available to assist.
  It is ludicrous to assume that (training or new
  technology) will render community
  gastroenterologist as competent as anesthesia
  professionals

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• From the Oct. 9, 2013
• Wall Street Journal Robots vs.
  Anesthesiologists
• JJ's New Sedation Machine Promises Cheaper
  Colonoscopies Doctors Fight Back By Jonathan D.
  Rockoff
• Anesthesiologists, who are among the highest-paid
  physicians, have long fought people in health
  care who target their specialty to curb costs.
  Now the doctors are confronting a different kind
  of foe machines.
• A new system called Sedasys, made by Johnson
  Johnson, would automate the sedation of many
  patients undergoing colon-cancer screenings
• .. Sedation Machine Promises Cheaper
  Colonoscopies
• would automate (the) sedation That could take
  anesthesiologists out of the room, eliminating a
  big source of income for the doctors. More than
  1 billion is spent each year sedating...

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Sedasys and ASA

• Slide presentation and Panel discussion
• At 2013 Annual Meeting in San Francisco
• Log into ASA member website for access-video Is
  Sedasys a Disruptive Device
• Ad hoc committee finalized recommendations for
  Sedasys on 1/22/14

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If all else fails
Video produced by Dr. Douglas Rex
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What We Know

• -endoscopy is a very low risk
• -Propopfol has high patient satisfaction
• -general anesthesia can improve diagnostic
  outcomes
• -the literature is full of biased studies

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What We Dont know

• -Safety outcomes NAPs vs Anesthesia
• -Replacing providers with machines is
  cost-effective

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But as long as these stories exist

• Propofol kills Michael Jackson

• 3 year old dies in dental office

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Our jobs are safe!
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Summary

• -compared providing anesthesia in the endoscopy
  suite vs the operating room
• -reviewed procedure types and anesthetic
  considerations
• -discussed evolution of anesthetic presence and
  effect of cost and efficiency
• -discussed impact of technology on the future

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References

• Rex DK, Heuss LT, Walker JA, Qi R. Trained
  registered nurses/endoscopy teams can administer
  propofol safely for endoscopy. Gastroenterology
  2005 129(5)1384-1391.
• Weaver JM. The great debate on nurse-administered
  propofol sedation (NAPS) Where should we
  stand? Anesthesia Progress, Summer 2006
  53(2)31-33.
• Rex DK, et al. Endoscopist-directed
  administration of propofol A worldwide safety
  experience. Gastroenterology, 2009
  137(4)1229-1237.
• Cote GA, et al. Incidence of sedation-related
  complications with propofol use during advanced
  endoscopic procedures. Clinical Gastroenterology
  and Hepatology, 2010 8(2)137-142.
• Metzner J, Domino KB. Risks of anesthesia or
  sedation outside the operating room the role of
  the anesthesia care provider. Curr Opin
  Anaesthesiol. 2010 23(4)523-31.
• Ootaki C et al. Does general anesthesia increase
  the diagnostic yield of endoscopic
  ultrasound-guided fine needle aspiration of
  pancreatic masses? Anesthesiology. 201
  117(5)1044-50.
• Rex DK. The Science and politics of propofol. Am
  J Gastroenterol, 2004 99(11)2080-3.
• Gervirtz. Nurse-administered propofol regularly
  puts patients
• at risk. Gastroendonews, 2005, May.

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Questions?
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