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?

This trial tests a new method for setting oxygen levels in critically ill patients on ventilators. It seeks to determine if a personalized approach to oxygen targets (the optimal oxygen level for each individual) can enhance recovery. Patients will either receive a tailored oxygen level based on their specific needs or the usual care without personalization. Suitable candidates for this trial include those in an intensive care unit using a ventilator for breathing assistance. As an unphased trial, this study provides an opportunity to contribute to innovative research that could improve personalized care for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this personalized SpO2 target method is safe for critically ill adults?

Research has shown that personalized oxygen levels might be safe for seriously ill adults. In earlier studies, patients who received customized oxygen targets experienced better health outcomes. A computer program predicts the best oxygen levels for each person, and trials have tested this method, showing promise in lowering death rates.

Safety data from these trials suggest that adjusting oxygen levels based on individual needs does not cause harm. For instance, patients who maintained oxygen levels between 94% and 98% during most of their ICU stay had lower death rates in the hospital. These findings indicate that personalized oxygen targets are well-tolerated by patients.

While researchers continue to study this personalized approach, current data supports its safety in similar situations, providing some confidence in its use for critically ill patients.12345

Why are researchers excited about this trial?

Researchers are excited about the Personalized SpO2 Target approach because it tailors oxygen levels to each critically ill patient’s unique needs. Unlike standard care, which uses a one-size-fits-all approach to oxygen therapy, this method employs a statistical model to determine the optimal oxygen saturation for individual patients. By personalizing SpO2 targets, the treatment aims to improve patient outcomes by providing more precise and effective care, potentially reducing complications associated with improper oxygen levels.

What evidence suggests that this trial's personalized SpO2 targets could be effective for critically ill adults?

Research has shown that setting personalized oxygen levels for critically ill patients can improve their outcomes. In this trial, participants in the Personalized SpO2 Target Group will have their oxygen levels adjusted based on a statistical model that considers their baseline characteristics. Studies using advanced computer techniques suggest that these customized targets might lower death rates. Specifically, one study predicted a 6.4% drop in deaths within 28 days when patients received oxygen adjusted to their specific needs. Although no overall difference was found between high and low oxygen levels, recent research indicates that personalized targets hold promise. These targets, tailored to each patient’s condition, could lead to better survival rates and improved care quality.12345

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?

This trial is for adults in intensive care who are on a breathing machine (mechanical ventilation) due to severe illness or trouble breathing. Participants must be in a participating hospital unit and currently receiving invasive mechanical ventilation.

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

Trial Overview

The study compares usual oxygen level targets with personalized SpO2 targets, which use a computer model to suggest the best oxygen range for each patient based on their unique health information. Patients are randomly assigned to either group.

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+

Citations

NCT07536984 | Examination of Personalized SpO2 Targets

Our recent randomized trial comparing higher versus lower SpO2 targets among 2,541 critically ill adults receiving mechanical ventilation in the medical ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38501205/

Individualized Treatment Effects of Oxygen Targets ... - PubMed

Oxygenation targets that are individualized using machine learning analyses of randomized trials may reduce mortality for critically ill adults.

Personalized SpO2 Target for Critical ...

The SpO2 target that results in the best outcomes for critically ill adults has historically been unknown. Randomized trials comparing use of a ...

Oxygen-Saturation Targets for Critically Ill Adults Receiving ...

The oxygenation target that optimizes clinical outcomes for critically ill adults remains unknown. Spo2 targets that are on the higher end of the range used in ...

Examination of Personalized SpO2 Targets | MedPath

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 ...