Tube Size Randomized Trial During Emergency Tracheal Intubation

Enrolling by invitation · Not applicable

Conditions studied: Acute Respiratory Failure

In brief

The BREATHE trial is a parallel-group, pragmatic, randomized clinical trial comparing the effectiveness of smaller versus larger endotracheal tubes for mechanical ventilation of critically ill adults at 7 geographically diverse centers. A total of 3,180 critically ill adults undergoing tracheal intubation in the ED or ICU will be enrolled. Enrolled patients will be randomly assigned in a 1:1 ratio to receive either a smaller endotracheal tube (a 6.5 mm endotracheal tube for patients shorter than 64 inches and a 7.0 mm endotracheal for patients at least 64 inches) or a larger endotracheal tube (a 7.5 mm endotracheal tube for patients shorter than 64 inches and a 8.0 mm endotracheal for patients at least 64 inches). Patients will be followed for 6 months after enrollment. The primary outcome will be breathlessness at 6 months. The secondary outcomes will be voice quality and swallowing at 6 months.

Key facts

Study ID

NCT06939361

Run by

Vanderbilt University Medical Center

People needed

3180

Starts

2025-05-06

Expected to finish

2029-06-01

Last updated by the study team

2025-12-08

Who can join

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

You may qualify if…

• Patient is undergoing orotracheal intubation with an endotracheal tube in a participating unit
• Planned operator is a clinician expected to routinely perform tracheal intubation in the participating unit

You may not qualify if…

• Patient is known to be less than 18 years old
• Patient is known to be pregnant
• Patient is known to be a prisoner
• Use of an endotracheal tube with subglottic suction is planned
• Operator has determined that use of a smaller endotracheal tube or a larger endotracheal tube is required or contraindicated for the optimal care of the patient
• Immediate need for tracheal intubation precludes safe performance of study procedures

Where it is running

• University of Alabama Hospital — Birmingham, Alabama, United States
• University of Colorado-Denver — Denver, Colorado, United States
• Denver Health Medical Center — Denver, Colorado, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Washington Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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