Patient Positioning and Airway Management During ERCP

Not Applicable

Completed

• Conditions: Airway Management
• Interventions: Other: general endotracheal anesthesia; Other: deep sedation without endotracheal intubation

• Registration Number: NCT02850887
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-21
• Study Start: 2016-07-25
• Study First Submitted QC: 2016-07-29
• Study First Posted: 2016-08-01
• Primary Completion: 2017-11-29
• Study Completion: 2018-01-04
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-02
• Last Update Posted: 2018-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
general endotracheal anesthesia	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
deep sedation without endotracheal intubation	deep sedation without endotracheal intubation	local anesthesia together with sedation (drug that produces sleep) and analgesia (drug that treats pain) only.

Primary Outcome Measures

Name	Time	Method
Incidence of sedation related adverse events or the need for airway maneuvers	approximately one year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Washington University School of Medicine in St Louis; 🇺🇸 Saint Louis, Missouri, United States