Patient Positioning and Airway Management During ERCP

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02850887
• Other study ID #: 201605151
• Status: Completed
• Phase: N/A
• First received: July 21, 2016
• Last updated: February 2, 2018
• Start date: July 25, 2016
• Est. completion date: January 4, 2018

Study information

• Verified date: February 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Airway Management

Intervention

Other:
• general endotracheal anesthesia
sedation with the use of endotracheal intubation
• deep sedation without endotracheal intubation
deep sedation without endotracheal airway management.

Locations

Country	Name	City	State
United States	Washington University School of Medicine in St Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

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