Clinical trial NCT03026322: Preventing Hypoxemia With Manual Ventilation During Endotracheal Intubation (PreVent) Trial
Official title: Preventing Hypoxemia With Manual Ventilation During Endotracheal Intubation (PreVent) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Respiratory Failure With Hypoxia
Endotracheal Intubation
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2017-01-20
Enrollment: 401
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Lowest arterial oxygen saturation
timeFrame: Induction to 2 minutes after completion of the airway management procedure
Secondary outcomes:
measure: Incidence of lowest oxygen saturation less than 90%
timeFrame: Induction to 2 minutes after completion of the airway management procedure
measure: Incidence of lowest oxygen saturation less than 80%
timeFrame: Induction to 2 minutes after completion of the airway management procedure
measure: Change in saturation from induction to lowest oxygen saturation
timeFrame: Induction to 2 minutes after completion of the airway management procedure
measure: Incidence of desaturation
timeFrame: Induction to 2 minutes after completion of the airway management procedure
measure: Lowest oxygen saturation in the 24 hours after intubation.
timeFrame: 24 hours after intubation
measure: Highest fraction of inspired oxygen in the 24 hours after intubation.
timeFrame: 24 hours after intubation
measure: Highest positive end expiratory pressure in the 24 hours after intubation.
timeFrame: 24 hours after intubation
measure: Lowest oxygen saturation, highest fraction of inspired oxygen, and highest positive end expiratory pressure from 0-1, 1-6, and 6- 24 hours after intubation.
timeFrame: 24 hours after intubation
measure: Operator-reported pulmonary aspiration
timeFrame: Induction to 2 minutes after completion of the airway management procedure
measure: New infiltrate on chest imaging in the 48 hours after intubation
timeFrame: 48 hours after intubation
measure: Operator-reported pulmonary aspiration, new chest x-ray infiltrate, OR lowest oxygen saturation < 80% (composite outcome)
timeFrame: 48 hours after intubation
measure: New pneumothorax or pneumomediastinum on chest imaging in the 24 hours after intubation
timeFrame: 24 hours after intubation
measure: Incidence of esophageal intubation
timeFrame: Induction to 2 minutes after completion of the airway management procedure
measure: Lowest systolic blood pressure (peri-procedural)
timeFrame: Induction to 2 minutes after completion of the airway management procedure
measure: New systolic blood pressure < 65 mmHg or new need for vasopressor
timeFrame: Induction to 2 minutes after completion of the airway management procedure
measure: Cardiac arrest within one hour of intubation
timeFrame: One hour after intubation.
measure: Death within one hour of intubation
timeFrame: One hour after intubation
measure: Cormack-Lehane grade of glottic view
timeFrame: Induction to 2 minutes after completion of the airway management procedure
measure: Operator-assessed difficulty of intubation
timeFrame: Induction to 2 minutes after completion of the airway management procedure
measure: Incidence of successful intubation on the first laryngoscopy attempt
timeFrame: Induction to 2 minutes after completion of the airway management procedure
measure: Number of laryngoscopy attempts
timeFrame: Induction to 2 minutes after completion of the airway management procedure
measure: Time from induction to successful intubation
timeFrame: Induction to 2 minutes after completion of the airway management procedure
measure: Need for additional airway equipment or a second operator
timeFrame: Induction to 2 minutes after completion of the airway management procedure
measure: In-hospital mortality
timeFrame: 28 days
measure: Ventilator-free days
timeFrame: 28 days
measure: Intensive care unit-free days
timeFrame: 28 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
city: New Orleans
country: United States
facility: Louisiana State University School of Medicine
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Health System
state: Louisiana
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Seattle
country: United States
facility: Harborview Medical Center, University of Washington
state: Washington
Study officials:
affiliation: Vanderbilt University Medical Center
name: Matthew W Semler, MD, MSc
role: STUDY_DIRECTOR
affiliation: Vanderbilt University Medical Center
name: Todd W Rice, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Casey JD, Janz DR, Russell DW, Vonderhaar DJ, Joffe AM, Dischert KM, Brown RM, Zouk AN, Gulati S, Heideman BE, Lester MG, Toporek AH, Bentov I, Self WH, Rice TW, Semler MW; PreVent Investigators and the Pragmatic Critical Care Research Group. Bag-Mask Ventilation during Tracheal Intubation of Critically Ill Adults. N Engl J Med. 2019 Feb 28;380(9):811-821. doi: 10.1056/NEJMoa1812405. Epub 2019 Feb 18.
citation: Casey JD, Janz DR, Russell DW, Vonderhaar DJ, Joffe AM, Dischert KM, Brown RM, Lester MG, Zouk AN, Gulati S, Stigler WS, Rice TW, Semler MW; PreVent Investigators and the Pragmatic Critical Care Research Group. Manual ventilation to prevent hypoxaemia during endotracheal intubation of critically ill adults: protocol and statistical analysis plan for a multicentre randomised trial. BMJ Open. 2018 Aug 10;8(8):e022139. doi: 10.1136/bmjopen-2018-022139.