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ENROLLING BY INVITATION
NCT06939361
NA

Tube Size Randomized Trial During Emergency Tracheal Intubation

Sponsor: Vanderbilt University Medical Center

View on ClinicalTrials.gov

Summary

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.

Official title: The Tube Size Randomized Trial During Emergency Tracheal Intubation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

3180

Start Date

2025-05-06

Completion Date

2029-06

Last Updated

2025-12-08

Healthy Volunteers

No

Interventions

OTHER

Smaller endotracheal tube

* Inner diameter 7.0 mm (for patients with a height ≥ 64 inches) * Inner diameter 6.5 mm (for patients with a height \< 64 inches)

OTHER

Larger endotracheal tube

* Inner diameter 8.0 mm (for patients with a height ≥ 64 inches) * Inner diameter 7.5 mm (for patients with a height \< 64 inches)

Locations (7)

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