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NCT03026322 · ClinicalTrials.gov registry record · NA
Preventing Hypoxemia With Manual Ventilation During Endotracheal Intubation (PreVent) Trial
A NA study of Respiratory Failure and Endotracheal Intubation, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 401
- Enrollment target
- 5
- Study locations
NCT03026322: Completed NA study of Respiratory Failure and Endotracheal Intubation, sponsored by Vanderbilt University Medical Center.
NCT03026322 is a NA study of Respiratory Failure and Endotracheal Intubation that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 401 participants, below the 4,514-participant average among 40 other Respiratory Failure trials with a reported enrollment target (91% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03026322, a NA study of Respiratory Failure and Endotracheal Intubation, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 401 participants
- Enrollment target
- 5
- Study locations
Study 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.
Primary Outcome
The lowest arterial oxygen saturation measured by continuous pulse oximetry (SpO2) between induction and 2 minutes after completion of the airway management procedure.
Conditions Studied
Interventions
- OTHER Manual Ventilation
- OTHER No Manual Ventilation
Study Locations (5)
Louisiana
- Louisiana State University School of Medicine - New Orleans
- Ochsner Health System - New Orleans
Alabama
- The University of Alabama at Birmingham - Birmingham
Tennessee
- Vanderbilt University Medical Center - Nashville
Washington
- Harborview Medical Center, University of Washington - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 401 participants |
| Start Date | 2017-03-15 |
| Est. Completion | 2018-07-06 |
| Phase | NA |
What the finished NCT03026322 record still lists
NCT03026322 is an interventional study that assigns participants to a tested intervention. The registered 401 participants enrollment target is mid-sized for trials with a published cap, below the 4,514-participant average among 40 other Respiratory Failure trials with a reported enrollment target (91% lower).
The record links to 3 conditions, with Respiratory Failure appearing as the primary indexed condition, and to 2 interventions - of which Manual Ventilation is the first listed.
NCT03026322 lists 5 locations in 4 states (Louisiana, Alabama, Tennessee).
Frequently Asked Questions
What is clinical trial NCT03026322 about?
NCT03026322 is a clinical study titled "Preventing Hypoxemia With Manual Ventilation During Endotracheal Intubation (PreVent) Trial". 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...
What is the current status of trial NCT03026322?
This trial is currently completed. It is a NA study. The enrollment target is 401 participants. The study started on 2017-03-15. Estimated completion is 2018-07-06.
What conditions does trial NCT03026322 study?
This clinical trial studies the following conditions: Respiratory Failure, Endotracheal Intubation, Respiratory Failure With Hypoxia.
What interventions are being tested in trial NCT03026322?
The interventions under investigation include: Manual Ventilation (OTHER), No Manual Ventilation (OTHER).
Who is sponsoring clinical trial NCT03026322?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03026322 being conducted?
This trial has 5 study locations across Alabama, Louisiana, Tennessee, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03026322's enrollment target sits among peer trials
401 12th of 40 higher than 29 of 40 other Respiratory Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Respiratory Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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