Preventing Hypoxemia With Manual Ventilation During Endotracheal Intubation (PreVent) Trial

NCT03026322 NA COMPLETED

Complications are common during endotracheal intubation of critically ill adults. Manual ventilation between induction and intubation ("bag-valve-mask" ventilation) has been proposed as a means of preventing hypoxemia, the most common complication of intubation outside the operating room. Safety and efficacy data, however, are lacking. PreVent is a randomized trial comparing manual ventilation between induction and laryngoscopy to no manual ventilation between induction an laryngoscopy during endotracheal intubation of critically ill adults. The primary efficacy endpoint will be the lowest arterial oxygen saturation. The primary safety endpoints will be the lowest oxygen saturation, highest fraction of inspired oxygen, and highest positive end-expiratory pressure in the 24 hours after the procedure.

Details

Lead sponsor	Vanderbilt University Medical Center
Phase	NA
Status	COMPLETED
Enrolment	401
Start date	Wed Mar 15 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Fri Jul 06 2018 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Respiratory Failure
• Respiratory Failure With Hypoxia
• Endotracheal Intubation

Interventions

• Manual Ventilation
• No Manual Ventilation

Countries

United States