Airway Management
Conditions
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.
Interventions
sedation with the use of endotracheal intubation
OTHERdeep sedation without endotracheal intubation
deep sedation without endotracheal airway management.
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of sedation related adverse events or the need for airway maneuvers | approximately one year |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed