Vanderbilt Clinical Trials

Pragmatic Investigation of optimaL Oxygen Targets Trial

Purpose

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.

Condition

Respiratory Failure

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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

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

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: In the PILOT trial, the entire study ICU will be assigned to a single SpO2 target (cluster-randomized) and the ICU will switch between lower, intermediate, and higher SpO2 targets every two months in a randomly generated sequence (cluster-crossover).
Primary Purpose: Treatment
Masking: Single (Outcomes Assessor)
Masking Description: Observer bias will be minimized by use of objective endpoints collected in duplicate by [1] study personnel blinded to group assignment and [2] automated data extraction from the electronic health record.

Arm Groups

Arm	Description	Assigned Intervention
Active Comparator Lower SpO2 Target	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%).	Other: Lower SpO2 Target SpO2 target 90% (range 88-92%)
Active Comparator Intermediate SpO2 Target	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%).	Other: Intermediate SpO2 Target SpO2 target 94% (range 92-96%)
Active Comparator Higher SpO2 Target	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%).	Other: Higher SpO2 Target SpO2 target 98% (range 96-100%)

More Details

Status: Completed
Sponsor: Vanderbilt University Medical Center

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.