Examination of Personalized SpO2 Targets

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT07536984
Status
Enrolling By Invitation

Conditions

  • Acute Respiratory Failure

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Personalized SpO2 Target — OTHER
    A personalized SpO2 target predicted to result in the best outcomes for a patient will be delivered by the physicians, nurses, and respiratory therapists as a part of routine clinical care.
  • Usual Care — OTHER
    Clinicians will determine the approach to supplemental oxygen administration without receiving information from the statistical model

Study Details

Mechanical ventilation involves titrating the fraction of inspired oxygen to maintain arterial oxygen saturation (SpO2). The SpO2 target that results in the best outcomes for critically ill adults has historically been unknown. Randomized trials comparing use of a higher SpO2 target (96-100%) vs a lower SpO2 target (88-92%) have not found an average treatment effect among patients overall. However, the optimal SpO2 target may differ for patients with different characteristics. Recently, data from randomized trials of SpO2 targets were used to derive and validate a statistical model that predicts which SpO2 target will result in the best outcomes for an individual patient based on his or her unique characteristics (personalized SpO2 target). This statistical model has been incorporated into the electronic health record at Vanderbilt such that, for each patient receiving mechanical ventilation in the medical intensive care unit, information on which SpO2 target is predicted to result in the best outcome for the patient can be made available to clinicians. However, the use of personalized SpO2 targets for critically ill adults receiving mechanical ventilation has never been examined in a randomized trial and whether using such a personalized SpO2 target in clinical care can improve patient outcomes remains unknown. This randomized trial will examine the effect of using information on the SpO2 target that is predicted to be best for a patient based on his or her unique characteristics (personalized SpO2 target) versus usual care.

Key Dates

Start date
May 12, 2026
Status verified
May 2026
Primary completion
Dec 31, 2029
Completion
Jan 31, 2030

Study Design

Enrollment
3,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Personalized SpO2 Target Group
    For patients in the personalized SpO2 target group, the statistical model within the electronic health record will use each patient's baseline characteristics to calculate the SpO2 target predicted to result in the best outcomes for that individual patient, either 98% (range, 96-100%) for patients predicted to benefit from a higher SpO2 target or 90% (range, 88-92%) for patients predicted to benefit from a lower SpO2 target. The personalized SpO2 target predicted to result in the best outcomes for a patient will be delivered by the physicians, nurses, and respiratory therapists as a part of routine clinical care.
  • Active Comparator: Usual Care Group
    For patients in the usual care group, clinicians will determine the approach to supplemental oxygen administration without receiving information from the statistical model.

Primary Outcome Measure

28-day in-hospital mortality [ Time Frame: From randomization to the first of hospital discharge or 28 days after randomization ]

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37232-

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