CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,541 enrolled
Drug / intervention
Lower SpO2 Target +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03537937
NCT03537937N/ACompleted

Pragmatic Investigation of optimaL Oxygen Targets (PILOT) Trial

Vanderbilt University Medical Center·interventional·Posted May 25, 2018·Updated Sep 25, 2023

In Brief

A clinical study evaluating Lower SpO2 Target, Intermediate SpO2 Target, and 1 other intervention for Respiratory Failure. Completed, enrolled 2,541 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMay 25, 2018
Enrollment StartJul 1, 2018
Primary CompletionJan 31, 2022
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 8.1 years ago

Interventions

Lower SpO2 Targetother

SpO2 target 90% (range 88-92%)

Intermediate SpO2 Targetother

SpO2 target 94% (range 92-96%)

Higher SpO2 Targetother

SpO2 target 98% (range 96-100%)