Acute Respiratory FailureEXPRESSNCT07536984
Examination of Personalized SpO2 Targets
A study testing Personalized SpO2 Target in people with Acute Respiratory Failure, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- Personalized SpO2 Target
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2026to Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is located in a participating unit
- Patient is receiving invasive mechanical ventilation
Who cannot join
- Patient is known to be less than 18 years old
- Patient is known to be pregnant
- Patient is known to be a prisoner
- Patient is receiving extracorporeal membrane oxygenation
- Clinician has determined that a specific approach to oxygen therapy is required or contraindicated for the optimal care of the patient
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
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.
Read the detailed description
Each year, 2-3 million critically ill adults in the United States receive invasive mechanical ventilation. In-hospital mortality among critically ill adults receiving mechanical ventilation remains approximately 25-35%. Approaches to care that decrease mortality for critically ill adults receiving invasive mechanical ventilation are urgently needed.
Mechanical ventilation universally involves titrating the fraction of inspired oxygen (FiO2) to maintain arterial oxygen saturation - as assessed by pulse oximetry (SpO2) or blood gas analysis (SaO2) - or arterial oxygen tension (e.g., PaO2). Using higher SpO2 targets (96-100%) provides a margin of safety against hypoxemia, but increases exposure to excess FiO2, hyperoxemia, and tissue hyperoxia, potentially causing oxidative damage and inflammation. Using lower SpO2 targets (88-92%) minimizes these risks but may increase exposure to hypoxemia and hypoxia-induced organ injury. Historically, the effects of higher versus lower SpO2 targets on patient outcomes were unknown.
Our recent randomized trial comparing higher versus lower SpO2 targets among 2,541 critically ill adults receiving mechanical ventilation in the medical intensive care unit (ICU) found that use of a higher versus lower SpO2 target did not result in overall differences in short-term outcomes (e.g., 28-day mortality) or long-term outcomes (e.g., cognition at 12 months). Results have been similar in multiple other large, randomized trials in different settings.
Randomized trials traditionally report the average effect of treatment on outcomes for the overall population. However, the effect of treatment on outcomes may differ for patients with different characteristics. Such nonrandom variation in the magnitude or direction of treatment effect is called heterogeneity of treatment effect. To understand which treatment will produce the best outcomes for a given patient, clinicians and patients need randomized trials to move beyond reporting the average treatment effect to reporting the effect of treatment on outcomes for an individual patient based on the patient's unique characteristics, referred to as individualized treatment effect.
Recently, we used the dataset from our trial of higher versus lower SpO2 targets to develop a statistical model to predict the effect of use of a higher versus lower SpO2 target on 28-day mortality for an individual patient, considering each of the patient's baseline characteristics simultaneously. This statistical model uses 24 patient characteristics available at the time of initiation of invasive mechanical ventilation to predict which SpO2 target will result in the best outcome for that patient. The model inputs are each patient's value for each of the 24 baseline characteristics. The model output is the predicted absolute effect of using a higher or lower SpO2 target on 28-day in-hospital mortality for the patient, conditional on all of the patient's values for the baseline characteristics. To validate the accuracy of this statistical model, we applied it to the dataset from a second, geographically and temporally distinct randomized trial of higher vs lower SpO2 targets. We found that, despite no significant average treatment effect in either trial, the effect of use of a higher versus lower SpO2 target on mortality ranged widely for individual patients, with many patients appearing to benefit from either a lower or a higher SpO2 target.
Before the statistical model is widely applied in a clinical care, a randomized trial is required to determine whether using information from the model to guide oxygen therapy improves patient outcomes, compared with usual care. The EXPRESS trial will be a randomized trial comparing a personalized SpO2 target group (in which clinicians receive information on the SpO2 target predicted to result in the best outcome for each patient) vs a usual care group (in which clinicians do not receive information on the SpO2 target predicted to result in the best outcome for each patient) among adults receiving mechanical ventilation in the ICU at Vanderbilt.
- Conditions
- Acute Respiratory Failure
- Being tested
- Personalized SpO2 Target, Usual Care
- Keywords
- Critical illness, Emergency airway management, Mechanical ventilation, Predictive model, Personalized medicine
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized SpO2 TargetOther
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.
Usual CareOther
Clinicians will determine the approach to supplemental oxygen administration without receiving information from the statistical model
| Study group | Role | What they receive |
|---|---|---|
| Personalized SpO2 Target Group | Active comparator | 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. Receives: Other: Personalized SpO2 Target |
| Usual Care Group | Active comparator | For patients in the usual care group, clinicians will determine the approach to supplemental oxygen administration without receiving information from the statistical model. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day in-hospital mortality
Death from any cause by day 28
Measured: From randomization to the first of hospital discharge or 28 days after randomization
Secondary outcomes (1)
Ventilator-free days through day 28
Number of days alive and free of invasive mechanical ventilation between enrollment and day 28
Measured: From randomization to the first of hospital discharge or 28 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start12 May 2026
- Primary completionDec 2029 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Matthew Semler, Vanderbilt University Medical Center
- Investigators
- Matthew W Semler, MD, MSCI, Principal investigator, Vanderbilt University Medical CenterAdam Wright, PhD, Principal investigator, Vanderbilt University Medical CenterJonathan D Casey, MD, MSCI, Study director, Vanderbilt University Medical CenterEdward T Qian, MD, MSACI, Study chair, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07536984
- Sponsor's protocol ID
- 241209
- Other IDs
- 1R61HL180352-01
- Acronym
- EXPRESS
- Status last verified
- May 2026
- First submitted
- 12 Apr 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Our approach to data management and sharing in the proposed EXPRESS trial will comply with the 2023 FINAL NIH Policy for Data Management and Sharing. We will also comply with the NHLBI policy for data sharing from clinical trials and epidemiological studies including submitting data to NHLBI BioData Catalyst (BDC) or a comparable repository active at the time of trial result publication. Procedures are planned for sharing de-identified data, as well as statistical coding and any software developed. In addition to sharing data, we will also make available the clinical protocol and statistical analysis plan. This will be done as supplemental material to the primary study manuscript so that it is shared in context with the clinical data.
Publications
Semler MW, Casey JD, Lloyd BD, Hastings PG, Hays MA, Stollings JL, Buell KG, Brems JH, Qian ET, Seitz KP, Wang L, Lindsell CJ, Freundlich RE, Wanderer JP, Han JH, Bernard GR, Self WH, Rice TW; PILOT Investigators and the Pragmatic Critical Care Research Group. Oxygen-Saturation Targets for Critically Ill Adults Receiving Mechanical Ventilation. N Engl J Med. 2022 Nov 10;387(19):1759-1769. doi: 10.1056/NEJMoa2208415. Epub 2022 Oct 24.
PubMed 36278971Buell KG, Spicer AB, Casey JD, Seitz KP, Qian ET, Graham Linck EJ, Self WH, Rice TW, Sinha P, Young PJ, Semler MW, Churpek MM. Individualized Treatment Effects of Oxygen Targets in Mechanically Ventilated Critically Ill Adults. JAMA. 2024 Apr 9;331(14):1195-1204. doi: 10.1001/jama.2024.2933.
PubMed 38501205ICU-ROX Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group; Mackle D, Bellomo R, Bailey M, Beasley R, Deane A, Eastwood G, Finfer S, Freebairn R, King V, Linke N, Litton E, McArthur C, McGuinness S, Panwar R, Young P; ICU-ROX Investigators the Australian and New Zealand Intensive Care Society Clinical Trials Group. Conservative Oxygen Therapy during Mechanical Ventilation in the ICU. N Engl J Med. 2020 Mar 12;382(11):989-998. doi: 10.1056/NEJMoa1903297. Epub 2019 Oct 14.
PubMed 31613432
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Personalized SpO2 Targets
- ClinicalTrials.gov ID
- NCT07536984
- Acronym / sponsor ID
- EXPRESS / 241209
- Conditions
- Acute Respiratory Failure
- Keywords
- Critical illness, Emergency airway management, Mechanical ventilation, Predictive model, Personalized medicine
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 12 May 2026 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Each year, 2-3 million critically ill adults in the United States receive invasive mechanical ventilation. In-hospital mortality among critically ill adults receiving mechanical ventilation remains approximately 25-35%. Approaches to care that decrease mortality for critically ill adults receiving invasive mechanical ventilation are urgently needed.
Mechanical ventilation universally involves titrating the fraction of inspired oxygen (FiO2) to maintain arterial oxygen saturation - as assessed by pulse oximetry (SpO2) or blood gas analysis (SaO2) - or arterial oxygen tension (e.g., PaO2). Using higher SpO2 targets (96-100%) provides a margin of safety against hypoxemia, but increases exposure to excess FiO2, hyperoxemia, and tissue hyperoxia, potentially causing oxidative damage and inflammation. Using lower SpO2 targets (88-92%) minimizes these risks but may increase exposure to hypoxemia and hypoxia-induced organ injury. Historically, the effects of higher versus lower SpO2 targets on patient outcomes were unknown.
Our recent randomized trial comparing higher versus lower SpO2 targets among 2,541 critically ill adults receiving mechanical ventilation in the medical intensive care unit (ICU) found that use of a higher versus lower SpO2 target did not result in overall differences in short-term outcomes (e.g., 28-day mortality) or long-term outcomes (e.g., cognition at 12 months). Results have been similar in multiple other large, randomized trials in different settings.
Randomized trials traditionally report the average effect of treatment on outcomes for the overall population. However, the effect of treatment on outcomes may differ for patients with different characteristics. Such nonrandom variation in the magnitude or direction of treatment effect is called heterogeneity of treatment effect. To understand which treatment will produce the best outcomes for a given patient, clinicians and patients need randomized trials to move beyond reporting the average treatment effect to reporting the effect of treatment on outcomes for an individual patient based on the patient's unique characteristics, referred to as individualized treatment effect.
Recently, we used the dataset from our trial of higher versus lower SpO2 targets to develop a statistical model to predict the effect of use of a higher versus lower SpO2 target on 28-day mortality for an individual patient, considering each of the patient's baseline characteristics simultaneously. This statistical model uses 24 patient characteristics available at the time of initiation of invasive mechanical ventilation to predict which SpO2 target will result in the best outcome for that patient. The model inputs are each patient's value for each of the 24 baseline characteristics. The model output is the predicted absolute effect of using a higher or lower SpO2 target on 28-day in-hospital mortality for the patient, conditional on all of the patient's values for the baseline characteristics. To validate the accuracy of this statistical model, we applied it to the dataset from a second, geographically and temporally distinct randomized trial of higher vs lower SpO2 targets. We found that, despite no significant average treatment effect in either trial, the effect of use of a higher versus lower SpO2 target on mortality ranged widely for individual patients, with many patients appearing to benefit from either a lower or a higher SpO2 target.
Before the statistical model is widely applied in a clinical care, a randomized trial is required to determine whether using information from the model to guide oxygen therapy improves patient outcomes, compared with usual care. The EXPRESS trial will be a randomized trial comparing a personalized SpO2 target group (in which clinicians receive information on the SpO2 target predicted to result in the best outcome for each patient) vs a usual care group (in which clinicians do not receive information on the SpO2 target predicted to result in the best outcome for each patient) among adults receiving mechanical ventilation in the ICU at Vanderbilt.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized SpO2 Target Group | Active comparator | Other: Personalized SpO2 TargetFor 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. |
| Usual Care Group | Active comparator | Other: Usual CareFor patients in the usual care group, clinicians will determine the approach to supplemental oxygen administration without receiving information from the statistical model. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient is located in a participating unit
- Patient is receiving invasive mechanical ventilation
Key exclusion criteria (5 listed)
- Patient is known to be less than 18 years old
- Patient is known to be pregnant
- Patient is known to be a prisoner
- Patient is receiving extracorporeal membrane oxygenation
- Clinician has determined that a specific approach to oxygen therapy is required or contraindicated for the optimal care of the patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized SpO2 TargetA 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 | Personalized SpO2 Target Group |
| Usual CareClinicians will determine the approach to supplemental oxygen administration without receiving information from the statistical model | Other | Usual Care Group |
Primary outcome
28-day in-hospital mortality
Time frame: From randomization to the first of hospital discharge or 28 days after randomization
Death from any cause by day 28
1 secondary outcome
Ventilator-free days through day 28
Time frame: From randomization to the first of hospital discharge or 28 days after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Background: PubMed 36278971Semler MW, Casey JD, Lloyd BD, Hastings PG, Hays MA, Stollings JL, Buell KG, Brems JH, Qian ET, Seitz KP, Wang L, Lindsell CJ, Freundlich RE, Wanderer JP, Han JH, Bernard GR, Self WH, Rice TW; PILOT Investigators and the Pragmatic Critical Care Research Group. Oxygen-Saturation Targets for Critically Ill Adults Receiving Mechanical Ventilation. N Engl J Med. 2022 Nov 10;387(19):1759-1769. doi: 10.1056/NEJMoa2208415. Epub 2022 Oct 24.
- Background: PubMed 38501205Buell KG, Spicer AB, Casey JD, Seitz KP, Qian ET, Graham Linck EJ, Self WH, Rice TW, Sinha P, Young PJ, Semler MW, Churpek MM. Individualized Treatment Effects of Oxygen Targets in Mechanically Ventilated Critically Ill Adults. JAMA. 2024 Apr 9;331(14):1195-1204. doi: 10.1001/jama.2024.2933.
- Background: PubMed 31613432ICU-ROX Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group; Mackle D, Bellomo R, Bailey M, Beasley R, Deane A, Eastwood G, Finfer S, Freebairn R, King V, Linke N, Litton E, McArthur C, McGuinness S, Panwar R, Young P; ICU-ROX Investigators the Australian and New Zealand Intensive Care Society Clinical Trials Group. Conservative Oxygen Therapy during Mechanical Ventilation in the ICU. N Engl J Med. 2020 Mar 12;382(11):989-998. doi: 10.1056/NEJMoa1903297. Epub 2019 Oct 14.
- Individual participant dataSharing planned: Yes. Our approach to data management and sharing in the proposed EXPRESS trial will comply with the 2023 FINAL NIH Policy for Data Management and Sharing. We will also comply with the NHLBI policy for data sharing from clinical trials and epidemiological studies including submitting data to NHLBI BioData Catalyst (BDC) or a comparable repository active at the time of trial result publication. Procedures are planned for sharing de-identified data, as well as statistical coding and any software developed. In addition to sharing data, we will also make available the clinical protocol and statistical analysis plan. This will be done as supplemental material to the primary study manuscript so that it is shared in context with the clinical data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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 study director
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized SpO2 Target in people with Acute Respiratory Failure, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day in-hospital mortality (time frame: From randomization to the first of hospital discharge or 28 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07536984, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.