Personalized SpO2 Target for Critical Illness

(EXPRESS Trial)

MW
JD
Overseen ByJonathan D Casey, MD, MSCI
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Vanderbilt University Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

MW

Matthew W Semler, MD, MSCI

Principal Investigator

Vanderbilt University Medical Center

AW

Adam Wright, PhD

Principal Investigator

Vanderbilt University Medical Center

JD

Jonathan D Casey, MD, MSCI

Principal Investigator

Vanderbilt University Medical Center

ET

Edward T Qian, MD, MSACI

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

Inclusion Criteria

* Patient is located in a participating unit
* Patient is receiving invasive mechanical ventilation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a personalized SpO2 target or usual care during mechanical ventilation

28 days
Continuous monitoring in ICU

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Personalized SpO2 Target

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Personalized SpO2 Target GroupActive Control1 Intervention
Group II: Usual Care GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials
922
Recruited
939,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+