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

PreVent is a prospective, parallel-group, pragmatic, 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 aim of the
PreVent trial is to compare the effect of manual ventilation between induction and intubation
versus no manual ventilation on the lowest arterial oxygen saturation experienced by
critically ill adults undergoing endotracheal intubation. The PreVent trial is anticipated to
begin enrollment in January 2017 and will enroll adults undergoing endotracheal intubation
with sedation and/or neuromuscular blockade in participating units. Patients will be
randomized 1:1 to manual ventilation versus no manual ventilation. In the manual ventilation
group, manual ventilation using a bag-valve-mask will be provided from the time of induction
until the time of endotracheal intubation, except during laryngoscopy. In the no manual
ventilation group, no manual ventilation will be provided between induction and endotracheal
intubation, except for the treatment of hypoxemia. The primary efficacy endpoint will be the
lowest arterial oxygen saturation during the procedure. 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 intubation. Conduct of the trial will be overseen
by a Data Safety Monitoring Board. An interim analysis will be performed after the enrollment
of 175 patients. The analysis of the trial will be conducted in accordance with a
pre-specified statistical analysis plan made publicly available prior to the conclusion of
enrollment. The initial planned enrollment of 350 patients was increased by the Data and
Safety Monitoring Board at the interim analysis to a final planned enrollment of 400
patients.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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