Examination of Personalized SpO2 Targets

Summary

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.

Conditions

• Acute Respiratory Failure

Interventions

OTHER

Personalized SpO2 Target

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.

OTHER

Usual Care

Clinicians will determine the approach to supplemental oxygen administration without receiving information from the statistical model

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Vanderbilt University Medical Center

  lead OTHER

Principal Investigators

• Matthew W Semler, MD, MSCI · Vanderbilt University Medical Center

• Adam Wright, PhD · Vanderbilt University Medical Center

• Jonathan D Casey, MD, MSCI · Vanderbilt University Medical Center

• Edward T Qian, MD, MSACI · Vanderbilt University Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-12

Primary Completion

2029-12-31

Completion

2030-01-31

Countries

• United States

Study Locations