Patient Positioning and Airway Management During ERCP

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

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 Overview

• Status: Completed
• Conditions: Airway Management
• Intervention / Treatment: Other: general endotracheal anesthesia; Other: deep sedation without endotracheal intubation

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63010
      • Washington University School of Medicine in St Louis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Other: general endotracheal anesthesia; sedation with the use of endotracheal intubation
Active Comparator: deep sedation without endotracheal intubation; local anesthesia together with sedation (drug that produces sleep) and analgesia (drug that treats pain) only.	Other: deep sedation without endotracheal intubation; deep sedation without endotracheal airway management.; Other Names: monitored anesthesia care (MAC)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine

Publications and helpful links

General Publications

• Smith ZL, Mullady DK, Lang GD, Das KK, Hovis RM, Patel RS, Hollander TG, Elsner J, Ifune C, Kushnir VM. A randomized controlled trial evaluating general endotracheal anesthesia versus monitored anesthesia care and the incidence of sedation-related adverse events during ERCP in high-risk patients. Gastrointest Endosc. 2019 Apr;89(4):855-862. doi: 10.1016/j.gie.2018.09.001. Epub 2018 Sep 11.

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2016
• Primary Completion (Actual): November 29, 2017
• Study Completion (Actual): January 4, 2018

Study Registration Dates

• First Submitted: July 21, 2016
• First Submitted That Met QC Criteria: July 29, 2016
• First Posted (Estimate): August 1, 2016

Study Record Updates

• Last Update Posted (Actual): February 6, 2018
• Last Update Submitted That Met QC Criteria: February 2, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 201605151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No