Personalized SpO2 Target for Critical Illness
(EXPRESS Trial)
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.12345Why 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?
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?
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
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
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
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
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 ...
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 ...
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trial.medpath.com
trial.medpath.com/clinical-trial/e2bcf50be8a2c8bb/nct07536984-personalized-spo2-targets-examinationExamination 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 ...
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