Pragmatic Investigation of optimaL Oxygen Targets Trial (PILOT)

Vanderbilt University Medical Center

Status: Completed

Conditions: Respiratory Failure

Treatments: Other: Higher SpO2 Target; Other: Lower SpO2 Target; Other: Intermediate SpO2 Target

Study type: Interventional

Funder types: Other

Identifiers

NCT03537937

171272

Details and patient eligibility

About

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.

Enrollment: 2,541 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years
2. Receiving mechanical ventilation through an endotracheal tube or tracheostomy
3. Admitted to the study ICU or admission to the study ICU from the emergency department is planned

Exclusion criteria

1. Known pregnancy or beta hCG level greater than the laboratory upper limit of normal in a patient capable of becoming pregnant
2. Known to be a prisoner

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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2,541 participants in 3 patient groups

Lower SpO2 Target

Active Comparator group

Description:

During invasive mechanical ventilation in a study location, the fraction of inspired oxygen will be titrated to target an arterial oxygen saturation of 90% (range 88-92%).

Treatment:

Other: Lower SpO2 Target

Intermediate SpO2 Target

Active Comparator group

Description:

During invasive mechanical ventilation in a study location, the fraction of inspired oxygen will be titrated to target an arterial oxygen saturation of 94% (range 92-96%).

Treatment:

Other: Intermediate SpO2 Target

Higher SpO2 Target

Active Comparator group

Description:

During invasive mechanical ventilation in a study location, the fraction of inspired oxygen will be titrated to target an arterial oxygen saturation of 98% (range 96-100%).

Treatment:

Other: Higher SpO2 Target