Recruiting

Standard vs. Endoscope

Sponsor:

Stanford University

Code:

NCT03879720

Conditions

Biliary Tract Diseases

Pancreatic Diseases

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Endoscope assisted endotracheal intubation [EAEI]

Study Details

Brief summary:

Comparison of standard endotracheal intubation and endoscopist-facilitated endotracheal intubation

Conditions

Biliary Tract Diseases

Pancreatic Diseases

Study ID

NCT03879720

Start date

Aug 30, 2018

Status verified date

Nov, 2019

Completion date

Dec, 2020

Anticipated

Primary completion date

Oct, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients undergoing ERCP at Stanford University Medical Center

Exclusion Criteria:

  • Unable to consent
  • Contra-indication to general anesthesia

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard Endotracheal Intubation (SEI)

the patient will be positioned supine on the gurney for intubation, with eventual position in the standard semi-prone ERCP position on the fluoroscopy table. Anesthesiologist-determined doses of Fentanyl, Versed, Propofol and Succinylcholine will be administered per standard of care and intubation will be accomplished by direct laryngoscopy or glidescope, with confirmation of endotracheal tube placement by auscultation.

experimental: Endoscope assisted endotracheal intubation [EAEI]

the patients will position themselves in the semi-prone position on the fluoroscopy table. Anesthesiologist-determined doses of Fentanyl, Versed and Propofol will be administered per standard of care. Succinylcholine will not be administered and therefore the patient will not be paralyzed. The endotracheal tube will be positioned on the mid-distal aspect of the ultra-slim endoscope and the ultra-slim endoscope will then be advanced into the trachea under direct endoscopic visualization to the level of the carina. The anesthesiologist will then advance the endotracheal tube over the endoscope into the trachea, and its position above the carina will be simultaneously confirmed endoscopically with the ultra-slim endoscope.

Interventions

Endoscope assisted endotracheal intubation [EAEI]

Endoscope assisted endotracheal intubation \[EAEI\] performed by anesthesiologist with endoscopist assistance.

Primary outcome measure

  • Time to Procedure Start [ Time Frame: up to 1 hour ]

Central Contacts and Locations

Central contacts

Locations

Stanford University Medical Center

Recruiting

Stanford, California, United States, 94304

Contacts

More Information

Sponsor

Stanford University

Last update posted

Nov 8, 2019

Last verified

Nov, 2019

Keywords

  • ERCP
  • Endoscopic Procedures
  • Anesthesia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2019-11-08.