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OpenTrials
Completed

NCT Number: NCT02850887

Patient Positioning and Airway Management During ERCP

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.

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Key information

Conditions

Airway Management

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine in St Louis

St Louis, Missouri, 63010, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

General endotracheal anesthesia

Other

sedation with the use of endotracheal intubation

deep sedation without endotracheal intubation

Other

deep sedation without endotracheal airway management.

Other names: monitored anesthesia care (MAC)

Primary outcomes

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

    Time frame: approximately one year

Secondary outcomes

  1. Procedure duration

    Time frame: intraoperative

  2. Time to cannulation of intended duct system

    Time frame: during the procedure

  3. Technical success of ERCP

    Time frame: approximately one year

  4. Immediate ERCP adverse events

    Time frame: Adverse events within 24 hours of ERCP

  5. Delayed adverse events

    Time frame: Adverse events occurring within 7 days

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Aug 1, 2016
Registry last updated
Feb 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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