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Bougie or Stylet In Patients Undergoing Intubation Emergently (BOUGIE)

NCT03928925 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1106

Last updated 2021-03-22

No results posted yet for this 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

  • Acute Respiratory Failure

Interventions

OTHER

Bougie

disposable tracheal tube introducer of approximately 70 cm in length

OTHER

Endotracheal Tube with Stylet

endotracheal tube preloaded with a removable, malleable stylet

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Jonathan D Casey, MD · Vanderbilt University Medical Center

  • Matthew W Semler, MD, MSc · Vanderbilt University Medical Center

  • Brian E Driver, MD · Hennepin County Medical Center, Minneapolis

  • Matthew E Prekker, MD · Hennepin County Medical Center, Minneapolis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-29
Primary Completion
2021-02-14
Completion
2021-03-13

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03928925 on ClinicalTrials.gov