Comparison of Standard and Endoscope Assisted Endotracheal Intubation

NCT03879720 | Unknown

• 1 other identifier: 47089
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison of standard endotracheal intubation and endoscopist-facilitated endotracheal intubation

Conditions

Biliary Tract Diseases; Pancreatic Diseases

Keywords

ERCP; Endoscopic Procedures; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Time to Procedure Start

  Time from patient entry into procedure room to insertion of endoscope/start of procedure

  up to 1 hour

Secondary Outcomes (9)

• Intubation Time (time from 'ready to intubate', to 'tube confirmation')

  up to 1 hour

• Patient positioning time

  up to 1 hour

• Staff required for patient positioning

  up to 20 minutes

• Staff survey/assessment of ergonomic strain

  up to 1 hour

• Need for special positioning equipment

  up to 20 minutes

Study Arms (2)

Standard Endotracheal Intubation (SEI)

ACTIVE COMPARATOR

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.

Procedure: Endoscope assisted endotracheal intubation [EAEI]

Endoscope assisted endotracheal intubation [EAEI]

EXPERIMENTAL

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.

Procedure: Endoscope assisted endotracheal intubation [EAEI]

Interventions

Endoscope assisted endotracheal intubation [EAEI] PROCEDURE

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

Also known as: Standard Endotracheal Intubation [SEI]

Endoscope assisted endotracheal intubation [EAEI]; Standard Endotracheal Intubation (SEI)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing ERCP at Stanford University Medical Center

You may not qualify if:

• Unable to consent
• Contra-indication to general anesthesia

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University Medical Center

Stanford, California, 94304, United States

RECRUITING

Related Publications (1)

• Barakat MT, Angelotti T, Ghosh S, Banerjee S. Prospective randomized comparison of endoscopist-facilitated endotracheal intubation and standard intubation for ERCP. Gastrointest Endosc. 2023 Sep;98(3):441-447. doi: 10.1016/j.gie.2023.02.032. Epub 2023 Mar 5.

  PMID: 36878302 DERIVED

MeSH Terms

Conditions

Biliary Tract Diseases; Pancreatic Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Central Study Contacts

Subhas Banerjee

CONTACT

650-723-2623; sbanerje@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: Randomization to standard endotracheal intubation or endoscopist-facilitated endotracheal intubation.

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: March 19, 2019
• Study Start: August 30, 2018
• Primary Completion: October 1, 2020
• Study Completion: December 1, 2020
• Last Updated: November 8, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)