Tube Size Randomized Trial During Emergency Tracheal Intubation

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.

NCT Number	NCT06939361
Lead Sponsor	Vanderbilt University Medical Center Collaborators: Patient-Centered Outcomes Research Institute
Conditions	Acute Respiratory Failure
Enrollment	3,180 participants
Start Date	2025-05-06
Primary Completion	2029-06 (estimated)
Study Completion	2029-06 (estimated)
Updated on ClinicalTrials.gov	2025-12-08