Bougie or Stylet In Patients Undergoing Intubation Emergently (BOUGIE)

Completed · Not applicable

Conditions studied: Acute Respiratory Failure

In brief

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.

Key facts

Study ID

NCT03928925

Run by

Vanderbilt University Medical Center

People needed

1106

Starts

2019-04-29

Expected to finish

2021-03-13

Last updated by the study team

2021-03-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is located in a participating unit of an adult hospital
• Planned procedure is tracheal intubation with sedative administration (or tracheal intubation without sedative administration during cardiac arrest)
• Planned operator is a clinician expected to routinely perform tracheal intubation in the participating unit
• Planned laryngoscopy device is a non-hyperangulated laryngoscope blade

You may not qualify if…

• Patient is pregnant
• Patient is a prisoner
• Urgency of intubation precludes safe performance of study procedures
• Operator feels an approach to intubation other than use of a bougie or use of an endotracheal tube with stylet would be best for the care of the patient
• Operator feels use of a bougie is required or contraindicated for the care of the patient
• Operator feels use of an endotracheal tube with stylet is required or contraindicated for the care of the patient

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of Colorado — Denver, Colorado, United States
• Denver Health and Hospital Authority — Denver, Colorado, United States
• University of Iowa Hospital — Iowa City, Iowa, United States
• Louisiana State University School of Medicine — New Orleans, Louisiana, United States
• Ochsner Medical Center | Ochsner Health System — New Orleans, Louisiana, United States
• Lincoln Medical Center — The Bronx, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Wake Forest Baptist Health — Lexington, North Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Harborview Medical Center, University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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