Comparison of Standard and Endoscope Assisted Endotracheal Intubation

NCT ID: NCT03879720

Last Updated: 2019-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-30

Study Completion Date

2020-12-31

Brief Summary

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Comparison of standard endotracheal intubation and endoscopist-facilitated endotracheal intubation

Detailed Description

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Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures are typically performed using general anesthesia. During anesthesia, the anesthesiologist inserts a breathing tube (endotracheal tube) into the patient's wind pipe (trachea) and a machine helps the patient breathe (mechanical ventilation) while they are unconscious. The breathing tube is inserted with a patient laying on his/her back using a rigid metallic device (laryngoscope) to guide tube placement. The unconscious patient is then moved from the portable bed onto the X-ray table by nursing staff. The patient also has to be turned to lie on their stomach on the X-ray table for the procedure. This standard approach carries a small risk of patient injury during breathing tube placement as well as while moving and turning the unconscious patient onto the X-ray table.

At our endoscopy unit, endoscopists have, on several occasions, used a slim gastroscope to place the breathing tube under direct visualization in patients who are already positioned on their stomach for ERCP. This approach is rapid and has been uniformly successful and safe.

We hypothesize that this endoscopist-facilitated intubation approach may expedite the procedure and minimize ergonomic strain for staff during patient repositioning while minimizing patient injury during breathing tube placement and repositioning. This study seeks to formally compares the two approaches for placement of a breathing tube.

Conditions

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Biliary Tract Diseases Pancreatic Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomization to standard endotracheal intubation or endoscopist-facilitated endotracheal intubation.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Endoscope assisted endotracheal intubation [EAEI]

Intervention Type PROCEDURE

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

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.

Group Type EXPERIMENTAL

Endoscope assisted endotracheal intubation [EAEI]

Intervention Type PROCEDURE

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

Interventions

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Endoscope assisted endotracheal intubation [EAEI]

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

Intervention Type PROCEDURE

Other Intervention Names

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Standard Endotracheal Intubation [SEI]

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing ERCP at Stanford University Medical Center

Exclusion Criteria

* Unable to consent
* Contra-indication to general anesthesia
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Subhas Banerjee

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Stanford University Medical Center

Stanford, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Subhas Banerjee

Role: CONTACT

650-723-2623

Facility Contacts

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Subhas Banerjee

Role: primary

650-723-2623

References

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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.

Reference Type DERIVED
PMID: 36878302 (View on PubMed)

Other Identifiers

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47089

Identifier Type: -

Identifier Source: org_study_id

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