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NCT03928925 · ClinicalTrials.gov registry record · NA

Bougie or Stylet In Patients Undergoing Intubation Emergently (BOUGIE)

A NA study of Acute Respiratory Failure, sponsored by Vanderbilt University Medical Center.

Completed
Registry status
NA
Development phase
1,106
Enrollment target
11
Study locations

NCT03928925 is a NA study of Acute Respiratory Failure that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 1,106 participants, below the 1,396-participant average among 13 other Acute Respiratory Failure trials with a reported enrollment target (21% lower). The trial reports 11 study locations across 8 states.

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The verdict

NCT03928925, a NA study of Acute Respiratory Failure, has completed, sponsored by Vanderbilt University Medical Center.

COMPLETED
Registry status
NA
Development phase
1,106 participants
Enrollment target
11
Study locations

Study Summary

Complications are common during tracheal intubations performed outside of the operating room. Successful intubation on the first attempt has been associated with a lower rate of procedural complications, but the proportion of critically ill patients intubated on the first attempt during tracheal intubations outside of the operating room is less than 90%. The bougie, a thin semi-rigid tube that can be placed into the trachea, allowing a Seldinger-like technique of intubating a patient's airway, has been traditionally reserved for difficult or failed airways. However, a recent single center trial of adult patients intubated in an emergency department demonstrated that use of the bougie on the first attempt improved intubation success, compared to use of a traditional stylet. Theinvestigators propose a multi-center randomized trial to compare first-attempt bougie use versus endotracheal tube with stylet use for tracheal intubation of critically ill adults in the ED and ICU.

Conditions Studied

Interventions

  • OTHER Bougie
  • OTHER Endotracheal Tube with Stylet

Study Locations (11)

Colorado

  • University of Colorado - Denver
  • Denver Health and Hospital Authority - Denver

Louisiana

  • Louisiana State University School of Medicine - New Orleans
  • Ochsner Medical Center | Ochsner Health System - New Orleans

North Carolina

  • Duke University Medical Center - Durham
  • Wake Forest Baptist Health - Lexington

Alabama

  • University of Alabama at Birmingham - Birmingham

Iowa

  • University of Iowa Hospital - Iowa City

New York

  • Lincoln Medical Center - The Bronx

Tennessee

  • Vanderbilt University Medical Center - Nashville

Washington

  • Harborview Medical Center, University of Washington - Seattle

Trial Details

FieldValue
Enrollment Target 1,106 participants
Start Date 2019-04-29
Est. Completion 2021-03-13
Phase NA

What the Registry Record Tells You About NCT03928925

The ClinicalTrials.gov registry entry for NCT03928925 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 1,106 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,396-participant average among 13 other Acute Respiratory Failure trials with a reported enrollment target (21% lower). The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Acute Respiratory Failure appearing as the primary indexed condition, and to 2 interventions - of which Bougie is the first listed.

NCT03928925 reports 11 study locations spanning 8 distinct geographic areas - top geographies include Colorado, Louisiana, North Carolina.

Frequently Asked Questions

What is clinical trial NCT03928925 about?

NCT03928925 is a clinical study titled "Bougie or Stylet In Patients Undergoing Intubation Emergently (BOUGIE)". Complications are common during tracheal intubations performed outside of the operating room. Successful intubation on the first attempt has been associated with a lower rate of procedural complications, but the proportion of critically ill patients intubated on the first attempt during tracheal int...

What is the current status of trial NCT03928925?

This trial is currently completed. It is a NA study. The enrollment target is 1,106 participants. The study started on 2019-04-29. Estimated completion is 2021-03-13.

What conditions does trial NCT03928925 study?

This clinical trial studies the following conditions: Acute Respiratory Failure.

What interventions are being tested in trial NCT03928925?

The interventions under investigation include: Bougie (OTHER), Endotracheal Tube with Stylet (OTHER).

Who is sponsoring clinical trial NCT03928925?

This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03928925 being conducted?

This trial has 11 study locations across Alabama, Colorado, Iowa, Louisiana, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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