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Patient Positioning and Airway Management During ERCP

Sponsor
Washington University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT02850887
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
17.3
Actual Duration (Months)
11.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: general endotracheal anesthesia
  • Other: deep sedation without endotracheal intubation
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
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
Actual Study Start Date :
Jul 25, 2016
Actual Primary Completion Date :
Nov 29, 2017
Actual Study Completion Date :
Jan 4, 2018

Arms and Interventions

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)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of sedation related adverse events or the need for airway maneuvers [approximately one year]

    Secondary Outcome Measures

    1. Procedure duration [intraoperative]

    2. Time to cannulation of intended duct system [during the procedure]

    3. Technical success of ERCP [approximately one year]

    4. Immediate ERCP adverse events [Adverse events within 24 hours of ERCP]

    5. Delayed adverse events [Adverse events occurring within 7 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    3. STOP-BANG score of 3 or higher

    4. Abdominal ascites on either physical exam or imaging within the last 14 days

    5. BMI greater than or equal to 35

    6. Chronic lung disease

    7. ASA class 4

    8. Mallampati Class 4 airway (only hard palate visible)

    9. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Washington University School of Medicine in St Louis Saint Louis Missouri United States 63010

    Sponsors and Collaborators

    • Washington University School of Medicine

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Washington University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT02850887
    Other Study ID Numbers:
    • 201605151
    First Posted:
    Aug 1, 2016
    Last Update Posted:
    Feb 6, 2018
    Last Verified:
    Feb 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Anesthetics

    Study Results

    No Results Posted as of Feb 6, 2018