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Pragmatic Investigation of optimaL Oxygen Targets Trial

NCT03537937 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2541

Last updated 2023-09-25

Study results available
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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

OTHER

Lower SpO2 Target

SpO2 target 90% (range 88-92%)

OTHER

Intermediate SpO2 Target

SpO2 target 94% (range 92-96%)

OTHER

Higher SpO2 Target

SpO2 target 98% (range 96-100%)

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Matthew W Semler, MD · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2022-01-31
Completion
2022-01-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03537937 on ClinicalTrials.gov