Airway Management Clinical Trial
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
Verified date | February 2018 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | January 4, 2018 |
Est. primary completion date | November 29, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Washington University School of Medicine in St Louis | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of sedation related adverse events or the need for airway maneuvers | approximately one year | ||
Secondary | Procedure duration | intraoperative | ||
Secondary | Time to cannulation of intended duct system | during the procedure | ||
Secondary | Technical success of ERCP | approximately one year | ||
Secondary | Immediate ERCP adverse events | Adverse events within 24 hours of ERCP | ||
Secondary | Delayed adverse events | Adverse events occurring within 7 days |
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