NCT02850887

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

July 25, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2018

Completed
Last Updated

February 6, 2018

Status Verified

February 1, 2018

Enrollment Period

1.3 years

First QC Date

July 21, 2016

Last Update Submit

February 2, 2018

Conditions

Airway Management

Outcome Measures

Primary Outcomes (1)

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

    approximately one year

Secondary Outcomes (5)

  • 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

Study Arms (2)

general endotracheal anesthesia

ACTIVE COMPARATOR

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

deep sedation without endotracheal intubation

ACTIVE COMPARATOR

local anesthesia together with sedation (drug that produces sleep) and analgesia (drug that treats pain) only.

Other: deep sedation without endotracheal intubation

Interventions

general endotracheal anesthesiaOTHER

sedation with the use of endotracheal intubation

general endotracheal anesthesia
deep sedation without endotracheal intubationOTHER

deep sedation without endotracheal airway management.

Also known as: monitored anesthesia care (MAC)
deep sedation without endotracheal intubation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine in St Louis

St Louis, Missouri, 63010, United States

Location

Related Publications (1)

  • 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.

    PMID: 30217726DERIVED

MeSH Terms

Interventions

Deep SedationIntubation, Intratracheal

Intervention Hierarchy (Ancestors)

Anesthesia and AnalgesiaAirway ManagementTherapeuticsIntubationInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2016

First Posted

August 1, 2016

Study Start

July 25, 2016

Primary Completion

November 29, 2017

Study Completion

January 4, 2018

Last Updated

February 6, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)