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

Completed · Not applicable

Conditions studied: Respiratory Failure, Respiratory Failure With Hypoxia, Endotracheal Intubation

In brief

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.

Key facts

Study ID

NCT03026322

Run by

Vanderbilt University Medical Center

People needed

401

Starts

2017-03-15

Expected to finish

2018-07-06

Last updated by the study team

2018-09-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is located in a participating unit
• Planned procedure is endotracheal intubation
• Planned operator is a provider expected to routinely perform endotracheal intubation in the participating unit
• Administration of sedation and/or neuromuscular blockade is planned
• Age ≥ 18 years old

You may not qualify if…

• Urgency of intubation precludes safe performance of study procedures
• Operator feels a specific approach to ventilation between induction and intubation is required
• Pregnant women
• Prisoners

Where it is running

• The University of Alabama at Birmingham — Birmingham, Alabama, United States
• Louisiana State University School of Medicine — New Orleans, Louisiana, United States
• Ochsner Health System — New Orleans, Louisiana, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Harborview Medical Center, University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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