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.

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