Patient Positioning and Airway Management During ERCP

Study Overview
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Brief Summary
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The aim of this study is to determine the effect of airway management (a set of medical procedures performed to prevent airway blockage and thus ensure an open path between a patient's lungs and the atmosphere) during endoscopic retrograde cholangiopancreatography [(ERCP), a procedure commonly used to treat conditions of the bile ducts and pancreas] and the effect on airway complications (problems), time to biliary cannulation (access into bile duct) and total procedure duration (length of time). Two methods are being compared and studied: 1) general endotracheal anesthesia: an inhalation anesthetic (substance that blocks pain) technique in which anesthetic and respiratory gases pass through a tube placed in the trachea (throat) via the mouth or nose vs 2) deep sedation without endotracheal intubation: local anesthesia together with sedation (drug that produces sleep) and analgesia (drug that treats pain) only.

Official Title
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Patient Positioning and Airway Management During Endoscopic Retrograde Cholangiopancreatography ERCP and the Effect on Airway Complications and Procedure Outcomes in Patients With Risks for Anesthesia Adverse Events

Conditions
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Airway Management

Intervention / Treatment
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* Other: general endotracheal anesthesia
* Other: deep sedation without endotracheal intubation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient undergoing ERCP without preceding endoscopic ultrasound (EUS) At least one of the following risk factors for adverse events during sedation: STOP-BANG score of 3 or higher Abdominal ascites on either physical exam or imaging within the last 14 days BMI greater than or equal to 35 Chronic lung disease ASA class 4 Mallampati Class 4 airway (only hard palate visible) Concurrent moderate to heavy alcohol use (≥4 drinks/day for men and ≥3 drinks/day for women) Exclusion Criteria: EUS preceding the ERCP Emergent indication for ERCP (eg cholangitis with septic shock) Presence of a tracheostomy Unstable airway Gastric outlet obstruction Altered foregut anatomy (eg Roux-en-Y gastric bypass, Billroth II) Inability to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: general endotracheal anesthesia<br>an inhalation anesthetic (substance that blocks pain) technique in which anesthetic and respiratory gases pass through a tube placed in the trachea (throat) via the mouth or nose | Other: general endotracheal anesthesia<br>* sedation with the use of endotracheal intubation<br>|
| Active Comparator: deep sedation without endotracheal intubation<br>local anesthesia together with sedation (drug that produces sleep) and analgesia (drug that treats pain) only. | Other: deep sedation without endotracheal intubation<br>* deep sedation without endotracheal airway management.<br>* Other names: monitored anesthesia care (MAC);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of sedation related adverse events or the need for airway maneuvers |  | approximately one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure duration |  | intraoperative | 
| Time to cannulation of intended duct system |  | during the procedure | 
| Technical success of ERCP |  | approximately one year | 
| Immediate ERCP adverse events |  | Adverse events within 24 hours of ERCP | 
| Delayed adverse events |  | Adverse events occurring within 7 days |