Patient Positioning and Airway Management During ERCP

The Washington University

Status: Completed

Conditions: Airway Management

Treatments: Other: general endotracheal anesthesia; Other: deep sedation without endotracheal intubation

Study type: Interventional

Funder types: Other

Identifiers

NCT02850887

201605151

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

general endotracheal anesthesia

Active Comparator group

Description:

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

Treatment:

Other: general endotracheal anesthesia

deep sedation without endotracheal intubation

Active Comparator group

Description:

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

Treatment:

Other: deep sedation without endotracheal intubation