Tube Size Randomized Trial During Emergency Tracheal Intubation

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Apr 14, 2025

Keywords

ClinConnect Summary

The BREATHE trial is a study designed to compare the use of smaller versus larger tubes during emergency intubation, which is a procedure to help people who are having trouble breathing. This trial will involve about 3,180 critically ill adults from various hospitals. Participants will be randomly assigned to receive either a smaller or larger tube based on their height. The main goal of the study is to see how these different tube sizes affect breathlessness six months after the procedure. Additionally, researchers will look at how the tube sizes may impact voice quality and swallowing.

To be eligible for this trial, participants need to be adults who are undergoing intubation by a trained clinician in a participating hospital. However, individuals under 18 years old, pregnant women, prisoners, or those who have specific medical needs that require a certain tube size will not be included. After joining the study, participants can expect to be followed up for six months to assess their breathing, voice, and swallowing abilities. This research aims to improve care for critically ill patients needing assistance with breathing.

Gender

ALL

Eligibility 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