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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: Completed NA study of Acute Respiratory Failure, sponsored by Vanderbilt University Medical Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary outcome is successful intubation on the first attempt. Successful intubation on the first attempt is defined as placement of an endotracheal tube in the trachea (confirmed by standard means including capnography) following: (1) a single insertion of a laryngoscope blade into the mouth and (2) EITHER a single insertion of a bougie into the mouth followed by a single insertion of an endotracheal tube into the mouth OR a single insertion of an endotracheal tube with stylet into the mout
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
| Field | Value |
|---|---|
| Enrollment Target | 1,106 participants |
| Start Date | 2019-04-29 |
| Est. Completion | 2021-03-13 |
| Phase | NA |
What the finished NCT03928925 record still lists
NCT03928925 is an interventional study that assigns participants to a tested intervention. Its 1,106 participants enrollment target places it among the larger protocols in the corpus, below the 1,396-participant average among 13 other Acute Respiratory Failure trials with a reported enrollment target (21% lower).
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 lists 11 locations in 8 states (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.
Learn More About Clinical Trials
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Where NCT03928925's enrollment target sits among peer trials
1,106 4th of 13 higher than 10 of 13 other Acute Respiratory Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Respiratory Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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