- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02850887
Patient Positioning and Airway Management During ERCP
February 2, 2018 updated by: Washington University School of Medicine
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63010
- Washington University School of Medicine in St Louis
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
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
|
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.
|
deep sedation without endotracheal airway management.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of sedation related adverse events or the need for airway maneuvers
Time Frame: approximately one year
|
approximately one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Procedure duration
Time Frame: intraoperative
|
intraoperative
|
Time to cannulation of intended duct system
Time Frame: during the procedure
|
during the procedure
|
Technical success of ERCP
Time Frame: approximately one year
|
approximately one year
|
Immediate ERCP adverse events
Time Frame: Adverse events within 24 hours of ERCP
|
Adverse events within 24 hours of ERCP
|
Delayed adverse events
Time Frame: Adverse events occurring within 7 days
|
Adverse events occurring within 7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Other Study ID Numbers
- 201605151
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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