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NCT03537937 · ClinicalTrials.gov registry record · NA
Pragmatic Investigation of optimaL Oxygen Targets Trial
A NA study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 2,541
- Enrollment target
NCT03537937: Completed NA study, sponsored by Vanderbilt University Medical Center.
NCT03537937 is a NA study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 2,541 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (81% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03537937, a NA study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 2,541 participants
- Enrollment target
Study Summary
Mechanical ventilation of ICU patients universally involves titration of the fraction of inspired oxygen (FiO2) to maintain arterial oxygen saturation (SpO2). Despite decades of ICU practice, however, the optimal SpO2 target remains unknown. Current guidelines offer divergent recommendations as to the optimal SpO2 target. Therefore, we propose a 2,250-patient cluster-randomized cluster-crossover trial comparing a lower SpO2 target (90%; range 88-92%), an intermediate SpO2 target (94%; range 92-96%), and a higher SpO2 target (98%; range 96-100%) with regard to the outcome of days alive and free of invasive mechanical ventilation.
Primary Outcome
Number of days alive and free from invasive mechanical ventilation between the final liberation from invasive mechanical ventilation before 28 days and study day 28. Patients who continue to receive invasive mechanical ventilation at day 28 or have died prior to day 28 will receive zero VFDs. For patients who return to invasive mechanical ventilation and are subsequently liberated from invasive mechanical ventilation prior to day 28, VFDs will be counted from final liberation from mechanical ven
Interventions
- OTHER Lower SpO2 Target
- OTHER Intermediate SpO2 Target
- OTHER Higher SpO2 Target
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,541 participants |
| Start Date | 2018-07-01 |
| Est. Completion | 2022-01-31 |
| Phase | NA |
What the finished NCT03537937 record still lists
NCT03537937 is an interventional study that assigns participants to a tested intervention. Its 2,541 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (81% higher).
The record links to 0 conditions, and to 3 interventions - of which Lower SpO2 Target is the first listed.
NCT03537937 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03537937 about?
NCT03537937 is a clinical study titled "Pragmatic Investigation of optimaL Oxygen Targets Trial". Mechanical ventilation of ICU patients universally involves titration of the fraction of inspired oxygen (FiO2) to maintain arterial oxygen saturation (SpO2). Despite decades of ICU practice, however, the optimal SpO2 target remains unknown. Current guidelines offer divergent recommendations as to t...
What is the current status of trial NCT03537937?
This trial is currently completed. It is a NA study. The enrollment target is 2,541 participants. The study started on 2018-07-01. Estimated completion is 2022-01-31.
What interventions are being tested in trial NCT03537937?
The interventions under investigation include: Lower SpO2 Target (OTHER), Intermediate SpO2 Target (OTHER), Higher SpO2 Target (OTHER).
Who is sponsoring clinical trial NCT03537937?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03537937's enrollment target sits among peer trials
2,541 44th of 2000 higher than 1,957 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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