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Bougie or Stylet In Patients Undergoing Intubation Emergently (BOUGIE)
NCT03928925 · View on ClinicalTrials.gov ↗
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
| Field | Value |
|---|---|
| Enrollment Target | 1,106 participants |
| Start Date | 2019-04-29 |
| Est. Completion | 2021-03-13 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03928925
The ClinicalTrials.gov registry entry for NCT03928925 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,106 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 695 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03928925 reports 11 study locations spanning 8 distinct geographic areas — top geographies include Colorado, Louisiana, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03928925?
The interventions under investigation include: Bougie (OTHER), Endotracheal Tube with Stylet (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03928925?
This trial is sponsored by Vanderbilt University Medical Center, which has 695 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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