Comparing smaller and larger endotracheal tubes for emergency intubation
The Tube Size Randomized Trial During Emergency Tracheal Intubation
This study tests whether using smaller or larger breathing tubes during emergency intubation helps critically ill adults breathe better and have fewer problems with their voice and swallowing after six months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 7 sites (Birmingham, Alabama and 6 other locations) |
| Trial ID | NCT06939361 on ClinicalTrials.gov |
What this trial studies
The BREATHE trial is a randomized clinical trial that evaluates the effectiveness of smaller versus larger endotracheal tubes in mechanically ventilating critically ill adults. Conducted at seven diverse centers, the trial will enroll 3,180 patients undergoing tracheal intubation in emergency departments or intensive care units. Participants will be randomly assigned to receive either a smaller or larger endotracheal tube based on their height. The primary outcome measured will be breathlessness at six months, with secondary outcomes including voice quality and swallowing difficulties.
Who should consider this trial
Good fit: Ideal candidates are critically ill adults undergoing orotracheal intubation in participating medical units.
Not a fit: Patients under 18 years old, pregnant individuals, or those with specific contraindications for tube size will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved long-term respiratory and swallowing outcomes for critically ill patients.
How similar studies have performed: Previous studies have indicated variability in endotracheal tube size selection, suggesting that this approach may yield novel insights into optimal airway management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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 this trial is running
Birmingham, Alabama and 6 other locations
- University of Alabama Hospital — Birmingham, Alabama, United States (Not_yet_recruiting)
- University of Colorado-Denver — Denver, Colorado, United States (Not_yet_recruiting)
- Denver Health Medical Center — Denver, Colorado, United States (Not_yet_recruiting)
- Hennepin County Medical Center — Minneapolis, Minnesota, United States (Not_yet_recruiting)
- Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States (Not_yet_recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
- University of Washington Medical Center — Seattle, Washington, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Jonathan D. Casey, MD, MSCI
- Email: Jonathan.d.Casey@vumc.org
- Phone: 615-208-6139
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.