Patient Positioning and Airway Management During ERCP

Washington University School of Medicine200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

200

Conditions

Airway Management

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patient undergoing ERCP without preceding endoscopic ultrasound (EUS) 2. At least one of the following risk factors for adverse events during sedation: 1. STOP-BANG score of 3 or higher 2. Abdominal ascites on either physical exam or imaging within the last 14 days 3. BMI greater than or equal to 35 4. Chronic lung disease 5. ASA class 4 6. Mallampati Class 4 airway (only hard palate visible) 7. Concurrent moderate to heavy alcohol use (≥4 drinks/day for men and ≥3 drinks/day for women) Exclusion Criteria: 1. EUS preceding the ERCP 2. Emergent indication for ERCP (eg cholangitis with septic shock) 3. Presence of a tracheostomy 4. Unstable airway 5. Gastric outlet obstruction 6. Altered foregut anatomy (eg Roux-en-Y gastric bypass, Billroth II) 7. Inability to give informed consent

Outcomes

Primary Outcomes

Incidence of sedation related adverse events or the need for airway maneuvers

Time frame: approximately one year

Secondary Outcomes

Procedure duration

Time frame: intraoperative

Time to cannulation of intended duct system

Time frame: during the procedure

Technical success of ERCP

Time frame: approximately one year

Immediate ERCP adverse events

Time frame: Adverse events within 24 hours of ERCP

Delayed adverse events

Time frame: Adverse events occurring within 7 days