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Tube Size Randomized Trial During Emergency Tracheal Intubation
Sponsor: Vanderbilt University Medical Center
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
Conditions
Interventions
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)
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