ANESTHESIA

IN R

EMOTE

LOCAT

IONS

SHAR

ON

ST E R

N M

D

S TARK C

OU

NT Y A

NE S TH

E S I A,

I NC

.

GOALS FOR THIS LECTURE

• EXPLORE REASONS WHY WE ARE PROVIDING SO MUCH MORE OF THESE SERVICES

• DISCUSS THE UNIQUE DEMANDS AND RISKS OF ANESTHETIZING IN REMOTE LOCATIONS AND DEVELOP STRATEGIES TO IMPROVE PATIENT SAFETY AND MINIMIZE LIABILITY

• COMPARE OURSELVES TO NON-ANESTHESIA PROVIDERS IN THE SEDATION ARENA

GOALS

• UNDERSTAND THE PURPOSE OF ASA CLOSED CLAIMS PROJECT

• REVIEW FINDINGS OF ASA CLOSED CLAIMS DATA PERTINENT TO ANESTHESIA IN REMOTE LOCATIONS

• PRACTICE STANDARDS AND GUIDELINES IN REMOTE LOCATIONS

• DISCUSS STRATEGIES FOR SPECIFIC LOCATIONS

WHAT DO WE NEED TO DO DIFFERENTLY?

WHERE WILL I BE TODAY?• Growing demand for anesthesia services

outside of the operating room over the past few decades due to:

• Advances in diagnostic and interventional procedures in fixed locations such as special radiology units (MRI, CT), cardiac cath and EP labs, radiation oncology, endoscopy suites, dental clinics, burn units, psychiatric units for ECT, renal units for lithotripsy (trailer trash), bedside tracheostomy in ICU, and gynecologic units for IVF.

WHERE WILL I BE TODAY?

• Constraints on time for OR availability for non-surgical anesthesia

• Legitimate need of certain patient groups (pediatric, mentally challenged, high risk co-morbidities such as severe OSA/BiPAP, super morbid obesity, severe end organ dysfunction)

• Demands of patients for sedation and lack of recall (pediatric dental, GI endoscopy, claustrophobic patients for imaging studies.)

I

INHERENT PROBLEMS AND CHALLENGES

The delivery of safe anesthesia in remote

locations is made difficult for a variety of

confounding circumstances.

INHERENT PROBLEMS As non-surgical patients, often

fall through the cracks as far as pre-testing.

Not properly evaluated preoperatively

Results in rushing the day of the procedure

Results in delays in remote location and delays in the OR later in the day due to the domino effect of tardiness anywhere in the process

INHERENT PROBLEMS

Cramped rooms Poor lighting Staff unfamiliar with anesthetized

patients and our equipment Potential lack of rigorous pre-

procedural check-in processes Far from colleagues and back up

help in a crisis situation

INHERENT PROBLEMS

Inadequate anesthesia support

Staff unfamiliar with anesthetized patients and our equipment

Lack of rigorous pre-procedural check-in processes

Far from colleagues and back up help in a crisis

INHERENT PROBLEMS Unfamiliar environment Anesthesia equipment often different

than OR equipment Physical set up different Inadequate monitoring equipment Inadequate stocking of supplies and

drugs Equipment may not be well maintained

or checked routinely.

I

US VERSUSTHEM

DO WE M

ATTE

R?

DO WE MATTER?

How good a job has our non-anesthesia colleagues done in

providing procedural sedation?

DO WE MATTER?

Not so good, apparently, or our services would not be so much more frequently requested or demanded.

Many reasons: US patients DEMAND sedation, and not just mild to moderate sedation (benzodiazepine based with or without opioids)

Demanding deep sedation with a shift towards Propofol as the agent of choice

Propofol

• Sedative, hypnotic• Respiratory depression• Hypotension• Anti-emetic• How did we practice

before this agent?

RISKS OF SEDATION BY NON-ANESTHESIA PROVIDERS

What have we learned from our gastroenterology

colleagues regarding safety of sedating this patient

population? What types of patients have they harmed?

.

WHAT HAPPENED?

Switch from benzodiazepine/opioid based sedation protocol to Propofol

Highly controversial issue (credentialing, literature, media)

Only advantage conferred by Propofol is a shorter recovery time

Catastrophic disadvantages of Propofol administered by non-anesthesia providers,

INADEQUATE STUDIES

Studies lack adequate numbers and statistical power.

They did not monitor ETCO2, so apneic episodes were often missed.

Few of the patients in published studies were sick (ASA III,IV, V), obese, or had sleep apnea.

Most studies poorly controlled and fail to meet inclusion criteria for the primary objectives of the proposed study design.

SEEMS LIKE WE ARE ALL HAVING THE SAME PROBLEM WITH OLDER, SICKER, HEAVIER PATIENTS. NO

WONDER THEY’RE HAVING TROUBLE AND NEED US!

CAPNOGRAPHY

Apnea lasting longer than 30 seconds is missed in 63% of patients by endoscopists,

In ER’s where MD’s are administering Propofol for sedation, capnography identified all cases of hypoxemia BEFORE the onset of O2 saturations plummeting. Median time from capnographic evidence of respiratory depression to hypoxemia was 60 seconds.

ASA recommends the use of ETCO2 monitoring to assess adequacy of ventilation during MAC with Propofol (ASAHQ Statement on Safe Use of Propofol, 17 March, 2010)

THEIR LITERATURE

Rex looked at 646,000 endoscopist directed Propofol sedations for EGD and colonoscopies and documented 4 deaths. All were ASA 3 or 4.

Estimated cost per life-year saved was $5.3Million, if anesthesiologists were substituted and had prevented all the deaths.

THEIR LITERATURE Problem: While their literature fails to

show huge differences in morbidity and mortality between non-anesthesia provided sedation, insurance companies reimburse our services – they recognize the safety value of our care or they wouldn’t pay.

Reality: Code blues/Rapid response calls in these remote locations were a common occurrence in the past and continue to be a reality even today.

Again, our patient population is their, too.

ASA CLOSED CLAIMS PROJECT

1980’s – crisis of affordability in professional liability insurance

Anesthesiologists – bad risk3% of insured physicians, but 11% of total dollars paid for patient injury

Risk reflected in soaring malpractice premiums

Ellison Pierce, Jr. MD1984 President of ASA

Programs to improve patient safety and prevent anesthetic injury

Closed Claims Project, assigned to ASA Committee on Professional Liability

PROBLEM WITH DATA ACQUISITION

1

• 1984 – little comprehensive information on the scope and cause of anesthetic injury in US

2• Significant anesthesia injury is a

relatively rare occurrence.

3

• Therefore, difficult to study prospectively or by retrospective medical record review, even from multiple institutions.

SOLUTION

1• Study of insurance company closed claims

2

• Cost-effective approach to data collection, extensive data on injuries from many different institutions.

3

• All this data could be gathered in one centralized location, the ASA Closed Claims Data Base.

DATA OBTAINED FROM INSURANCE COMPANIES

1• Hospital Record• Anesthesia Record

2

• Narrative statements of involved personnel

• Expert and peer reviews

3

• Deposition summaries, outcome reports

• Cost of settlement or jury awards

TASK OF CLOSED CLAIMS PROJECT

1

• Provide a concentrated collection of information on relatively rare events leading to anesthesia-related injury.

2

• Gain access to and collect information from professional liability organizations throughout the USA.

3

• Identify the major areas of anesthesia-related patient injury and design strategies to improve patient safety.

INHERENT LIMITATIONS OF CLOSED CLAIMS

1

• Not all malpractice insurance companies have cooperated and provided closed claims data.

2

• By 1999 insurance companies covering only 14,500 of the total 23,000 practicing anesthesiologists cooperated with the Closed Claims Database.

3

• Do not have the denominator of total number of cases done by those 14,500 anesthesiologists, therefore, closed claims data do not generate calculated risk data of anesthetic injury.

ORIGINAL CLOSED CLAIMS RESULTS

1• 4000 claims from 1970-1994

2

• Reviewed by volunteer anesthesiologists using standardized data collection.

3• Assess of cause of injury and

appropriateness of care by several reviewers

ORIGINAL CLAIMS DATA

1• Claims entered in data base on

anonymous basis.

2

• No identification of defendant, plaintiff, location, institution, company so impossible to match claims in data base to their source files.

3• Funded entirely by the ASA

HOW IS DATA USED?

1

• Ongoing analysis of database. Any emerging patterns of injury prompts action.

2

• Triggers a manuscript for peer reviewed journals for further analysis of emerging patient safety and liability issues.

3• All results are reported in meeting

abstracts and the ASA Newsletter.

Copyright © 2012 Anesthesiology. Published by Lippincott Williams & Wilkins.

Figure 1

Figure 1. The incidence of death, brain damage, and nerve injury as a percentage of total claims in a given time period. A significant reduction in the proportion of claims for death and brain damage occurred between 1970–1979 and 1990–1994 (*P <or= to 0.01, Z test).

34

The American Society of Anesthesiologists Closed Claims Project: What Have We Learned, How Has It Affected Practice, and How Will It Affect Practice in the Future? Cheney, Frederick W.Anesthesiology. 91(2):552-556, August 1999.doi:

CARDIAC ARREST WITH SAB

6 deaths, 8 permanent brain damage. Hypothesis: Poor cerebral perfusion pressure

during closed cardiac massage in the presence of high sympathetic blockade.

Advocated early administration of epinephrine in response to severe bradycardia and hypotension with SAB

Example of how the Closed Claims Database results in modifications of practice patterns resulting in improved patient safety.

MAJOR TRENDS FROM DATABASE

1• Respiratory system events large

share of claims

2• Large percentage of claims for

death and brain injury

3

• Most common events: inadequate ventilation, esophageal intubation, difficult tracheal intubation

ASA COMMITTEE OF STANDARDS

1

• Resulted in formulation of standards requiring use of pulse oximetry intraoperatively

2

• The use of ETCO2 for the verification of endotracheal intubation

3• The use of pulse oximetry in the

PACU

FUTURE TRENDS AND IMPROVED SAFETY

Question?

Does SaO2 and ETCO2 monitoring improve patient safety?

Severity of injury decreasing, fewer claims for brain death and brain injury from 1970’s to 1990’s Increase in claims for minor injuries

Significant decrease in malpractice premiums implies an overall reduction in severe injuries

MORE TRENDS NOTED

Severe injuries (death and brain damage) cause has changed over time.

Inadequate ventilation and esophageal intubations 2-3 time more common pre-SaO2 and ETCO2 monitoring

Difficult intubation claims fairly static over time frame (before algorithms and advanced airway devices)

Nerve injuries have become leading cause of anesthesia related injury – suggests the mechanism of such injuries still not yet known.

Figure 2

Figure 2. The incidence of respiratory, cardiovascular, and equipment related ‐damaging events as a percentage of the total claims for death and brain damage in each time period (*P <or= to 0.05, Z test) (compared with 1970–1979).

Copyright © 2012 Anesthesiology. Published by Lippincott Williams & Wilkins. 40

The American Society of Anesthesiologists Closed Claims Project: What Have We Learned, How Has It Affected Practice, and How Will It Affect Practice in the Future? Cheney, Frederick W.Anesthesiology. 91(2):552-556, August 1999.doi:

RISK OF ANESTEHSIA CARE IN REMOTE LOCATIONS

C O P Y R I G H T © 2 0 0 9 W O LT E R S K LU W E R . P U B L I S H E D BY L I P P I N C O T T W I L L I A M S & W I L K I N S . 41

ASA CLOSED CLAIMS PROJECT REVIEW

Despite most procedures being relatively non-invasive, serious adverse outcomes occur.

Analyzed claims for injuries from 1990 and later in ASA Closed Claims Database to compare injuries associated with claims for anesthesia care in remote locations (87) and in the OR setting (3286)

ANESTHESIA PATIENT SAFETY FOUNDATION NEWSLETTER, SPRING/SUMMER 2011

1

• Compared to patients in the OR they were

• OLDER (20% >70 years old)

2• SICKER• 69% ASA 3-5

3• More often underwent an

EMERGENCY procedure (36%)

REMOTE LOCATION PATIENT IDENTIFIERS

MORE DIFFERENCES FROM THE OR

1

• MAC predominant anesthetic technique, 8 times more frequent than OR (50% vs.6%)

2

• GI Suite most commonly involved (32% claims), followed by cath lab or EP lab (25%).

3• MRI scanner most common

radiology claim location.

OR VS. REMOTE CLAIMS

1

• Severity of injury greater in remote locations (death, permanent brain damage)

2• Death rate double in remote

locations

3• Proportion of respiratory events

double in remote locations

MOST COMMON RESPIRATORY EVENT

1• INADEQUATE

OXYGENATION/VENTILATION

2• 7 TIMES MORE FREQUENT THAN OR

3• MORE OFTEN JUDGED AS BEING

PREVENTABLE BY BETTER MONITORING

RESPIRATORY DEPRESSION

1

• Overdose of sedative-hypnotic-analgesic responsible for 26/84 claims

2• Overdose responsible for 50% GI

claims

3

• Patient factors for over sedation were obesity, OSA, ASA Class 305, age >70

OTHER CHARACTERISTICS

1

• Propofol most common drug implicated in over dosage and injury or death

2

• Capnography only utilized in 15% of

• claims

3

• Absolutely no respiratory monitoring documented in another 15% of cases

CONCLUSIONS

SUBSTANDARD CARE, PREVENTABLE BY BETTER MONITORING, WAS IMPLICATED IN THE MAJORITY OF CLAIMS ASSOCIATED WITH DEATH.

REMEMBER, THESE WERE MAC AND GA ADMINISTERED BY US, NOT THEM!

RECOMMENDATIONS

1

• MAC in remote locations poses significant risk for over sedation and inadequate oxygenation/ventilation

2• Capnography can minimize

patient risk in remote locations

3

• Finally, GA with secured airway may be safer than deep sedation (MAC) in some patients (OSA) and certain procedures (prone, MRI scanner or anything with limited access to patient’s airway.

WHAT IS MAC?

1• Monitored anesthesia Care?

2• Minimal airway control?

3• Mostly apneic and cyanotic?

MONITORED ANESTHESIA CARE INCLUDES

Diagnosis and treatment of clinical problems that occur during the procedure

Support of vital functions Administration of sedatives, analgesics,

hypnotics, anesthetic agents or other medications as necessary for patient safety

Psychological support and physical comfort

DISTINGUISHING MAC FROM MODERATE SEDATION/ANALGESIA

(CONSCIOUS SEDATION)ECONOMICS COMMITTEE

AMENDED BY ASA HOUSE OF DELEGATES ON

OCTOBER 21, 2009

“MAC”

Monitored anesthesia care may include varying levels of sedation, analgesia and anxiolysis as necessary

“ If the patient loses consciousness and the ability to respond purposefully, the anesthesia care is a general anesthetic, irrespective of whether airway instrumentation is required”

ASA House of delegates- 2008

STANDARDS FOR BASIC MONITORING

Approved by ASA House of Delegate

Effective Date July 1, 2011

During moderate or deep sedation the adequacy of ventilation shall be evaluated by continual observation of QUALATATIVE CLINICAL SIGNS AND MONITORING FOR THE PRESENCE OF EXHALED CARBON DIOXIDE unless precluded or invalidated by the nature of the patient (monitoring with CPAP/BiPAP causing a leak), procedure, or equipment.

STATEMENT ON RESPIRATORY MONITORING DURING ENDOSCOPIC

PROCEDURES

Approved by the ASA House of Delegates Oct. 21, 2009

Monitoring of ETCO2 should be CONSIDERED for all endoscopies, especially of the upper GI tract (shared airway) when Propofol alone or in combo with benzodiazepines and/or opioids. ERCP, requiring the prone position, poses extreme danger and requires CAREFUL ATTENTION TO AIRWAY MANAGEMENT as ventilatory monitoring, airway maintenance and resuscitation may be especially difficult.

Metzner J, Posner KL, Domino KB. The risk and safety of anesthesia at remote locations. The US closed claims analysis. Curr Opinion Anaesthesiol. 2009;22:502-508

Metzner J, Posner KL, Domino KB. The risk and safety of anesthesia at remote locations. The US closed claims analysis. Curr Opinion Anaesthesiol. 2009;22:502-508

ASA Guidelines

• Reliable source of Oxygen…with back-up– Piped O2 encouraged, 1 full bottle– Checked before cases begin

• Reliable suction• Anesthetic gas Scavenger• Equipment:

– Self inflating bag capable of FiO2 90%– Adequate Drugs, Monitoring Equipment– Standard Anesthesia machine (if inhalational used)

ANESTHESIA STANDARDS OUTSIDE THE OR

Anesthesia equipment should be of the same caliber as that in the OR

Pre-anesthetic evaluation process should be the same as that for patients undergoing surgical procedures

RADIATION SAFETY

1

• A unique hazard in the radiology suite is radiation

• Exposure.

2• Dosimeters should be worn, lead aprons

and thyroid shields.

3

• Maximum annual dose 50 mSv (millisieverts)

• Pregnant women less than 0.5 mSv monthly

RADIATION SAFETY

4

• Movable leaded glass screens

5

• Remote monitoring via video link

6

• Warning that radiation is initiated

REACTIONS TO IODINATED CONTRAST

MILD SEVERE LIFE THREATENING

Nausea, Retching Vomiting Glottic Edema

Perception of warmth

Rigors Bronchospasm

Headache Feeling Faint Pulmonary Edema

Itchy Rash Chest Pain Life Threatening Arrhythmias

Urticaria Urticaria Cardiac Arrest

Bronchospasm, Dyspnea

Seizures/Unconsciousness

Abdominal Pain, Diarrhea

Arrhythmias

Renal Failure

67

68

Adults for MRI

Jaw elevation device (JED)

72

Do you stay in the scanner?Why?

• If pt is unstable• Study requires

suspended respirations

• Sound is 90-100 decibels

• No one can hear YOU scream

Advantages of TIVA

• Components can be regulated independently

• Anesthetic area remains unpolluted by trace concentrations of nitrous oxide/volatile agents

• Vaporizers are not needed• Prevents delivery of hypoxic mixtures• Non-triggering of malignant hyperthermia

Ketamine

• Analgesia• Sedation• Cardiovascular stability• Bronchodilation• Cheap!

• Tachycardia?• Secretions• Hallucinations

76

SedationSedation AnalgesiaAnalgesia

AmnesiaAmnesia AnxiolysisAnxiolysisHypnosisHypnosis

α2 Agonistsα2 Agonists

77

CT scan

Intubation for EGD?

• Patients with high risk for aspiration– Severe Gastric reflux– Achalasia– Bowel obstruction– Uncontrollable bleeding

– Otherwise patients receive MAC for upper endoscopy

ERCP- Technique

• Unless morbid obesity, MAC with propofol infusion and ketamine

• Midazolam- 1-2 mg• Propofol induction- 1-2 mg/kg• 25-50mg ketamine in 20cc propofol infusion at

30-40ug/kg/min• Decrease/eliminate ketamine and continue

with propofol