Patient Positioning and Airway Management During ERCP

Completed · Not applicable

Conditions studied: Airway Management

In brief

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.

Key facts

Study ID

NCT02850887

Run by

Washington University School of Medicine

People needed

200

Starts

2016-07-25

Expected to finish

2018-01-04

Last updated by the study team

2018-02-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Washington University School of Medicine in St Louis — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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