Personalized SpO2 Target for Critical Illness
(EXPRESS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Matthew W Semler, MD, MSCI
Principal Investigator
Vanderbilt University Medical Center
Adam Wright, PhD
Principal Investigator
Vanderbilt University Medical Center
Jonathan D Casey, MD, MSCI
Principal Investigator
Vanderbilt University Medical Center
Edward T Qian, MD, MSACI
Principal Investigator
Vanderbilt University Medical Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either a personalized SpO2 target or usual care during mechanical ventilation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Personalized SpO2 Target
How Is the Trial Designed?
2
Treatment groups
Active Control
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.
For patients in the usual care group, clinicians will determine the approach to supplemental oxygen administration without receiving information from the statistical model.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt University Medical Center
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
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