Clinical Trials Directory

Trials / Completed

CompletedNCT03537937

Pragmatic Investigation of optimaL Oxygen Targets Trial

Pragmatic Investigation of optimaL Oxygen Targets (PILOT) Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
2,541 (actual)
Sponsor
Vanderbilt University Medical Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERLower SpO2 TargetSpO2 target 90% (range 88-92%)
OTHERIntermediate SpO2 TargetSpO2 target 94% (range 92-96%)
OTHERHigher SpO2 TargetSpO2 target 98% (range 96-100%)

Timeline

Start date
2018-07-01
Primary completion
2022-01-31
Completion
2022-01-31
First posted
2018-05-25
Last updated
2023-09-25
Results posted
2023-09-25

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03537937. Inclusion in this directory is not an endorsement.