Status:
ENROLLING_BY_INVITATION
Tube Size Randomized Trial During Emergency Tracheal Intubation
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
Conditions:
Acute Respiratory Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
Each year, approximately 1% of the US population (2-3 million adults) experiences critical illness requiring placement of an endotracheal tube. While 60-80% of patients survive, more than half of surv...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
3180 Patients enrolled
Trial Details
Trial ID
NCT06939361
Start Date
May 6 2025
End Date
June 1 2029
Last Update
December 8 2025
Active Locations (7)
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1
University of Alabama Hospital
Birmingham, Alabama, United States, 35233
2
University of Colorado-Denver
Denver, Colorado, United States, 80045
3
Denver Health Medical Center
Denver, Colorado, United States, 80204
4
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415