[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07536984":3,"trial-entities:NCT07536984":104,"trial-summary:NCT07536984":108},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":43,"secondary_outcomes":48,"sex":52,"minimum_age":53,"maximum_age":54,"healthy_volunteers":55,"eligibility_criteria":56,"std_ages":67,"locations":70,"central_contacts":79,"overall_officials":80,"references":92,"see_also_links":103},"NCT07536984","241209","Examination of Personalized SpO2 Targets","ENROLLING_BY_INVITATION","2030-01","2026-05","2026-05-20","2026-05-12","Vanderbilt University Medical Center","OTHER",true,"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.","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.\n\nMechanical 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.\n\nOur 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.\n\nRandomized 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.\n\nRecently, 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.\n\nBefore 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.",[18],"Acute Respiratory Failure",[20,21,22,23,24],"Critical illness","Emergency airway management","Mechanical ventilation","Predictive model","Personalized medicine","INTERVENTIONAL","TREATMENT",[28],"NA",{"count":30,"type":31},3000,"ESTIMATED",[33,38],{"type":13,"name":34,"description":35,"armGroupLabels":36},"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.",[37],"Personalized SpO2 Target Group",{"type":13,"name":39,"description":40,"armGroupLabels":41},"Usual Care","Clinicians will determine the approach to supplemental oxygen administration without receiving information from the statistical model",[42],"Usual Care Group",[44],{"measure":45,"description":46,"timeFrame":47},"28-day in-hospital mortality","Death from any cause by day 28","From randomization to the first of hospital discharge or 28 days after randomization",[49],{"measure":50,"description":51,"timeFrame":47},"Ventilator-free days through day 28","Number of days alive and free of invasive mechanical ventilation between enrollment and day 28","ALL","18 Years",null,false,{"inclusion":57,"exclusion":60,"raw_text":66},[58,59],"Patient is located in a participating unit","Patient is receiving invasive mechanical ventilation",[61,62,63,64,65],"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","Inclusion Criteria:\n\n* Patient is located in a participating unit\n* Patient is receiving invasive mechanical ventilation\n\nExclusion Criteria:\n\n* Patient is known to be less than 18 years old\n* Patient is known to be pregnant\n* Patient is known to be a prisoner\n* Patient is receiving extracorporeal membrane oxygenation\n* Clinician has determined that a specific approach to oxygen therapy is required or contraindicated for the optimal care of the patient",[68,69],"ADULT","OLDER_ADULT",[71],{"facility":12,"city":72,"state":73,"zip":74,"country":75,"geoPoint":76},"Nashville","Tennessee","37232","United States",{"lat":77,"lon":78},36.16589,-86.78444,[],[81,84,86,89],{"name":82,"affiliation":12,"role":83},"Matthew W Semler, MD, MSCI","PRINCIPAL_INVESTIGATOR",{"name":85,"affiliation":12,"role":83},"Adam Wright, PhD",{"name":87,"affiliation":12,"role":88},"Jonathan D Casey, MD, MSCI","STUDY_DIRECTOR",{"name":90,"affiliation":12,"role":91},"Edward T Qian, MD, MSACI","STUDY_CHAIR",[93,97,100],{"pmid":94,"type":95,"citation":96},"36278971","BACKGROUND","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\u002FNEJMoa2208415. Epub 2022 Oct 24.",{"pmid":98,"type":95,"citation":99},"38501205","Buell 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\u002Fjama.2024.2933.",{"pmid":101,"type":95,"citation":102},"31613432","ICU-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\u002FNEJMoa1903297. Epub 2019 Oct 14.",[],{"nct_id":4,"conditions":105,"biomarkers":107},[18,106],"Critical Illness",[],{"nct_id":4,"found":14,"summary":109,"prompt_version":119},{"design":110,"status":111,"heading":112,"summary":113,"follow_up":114,"word_count":115,"commitments":116,"compensation":117,"drugs_mentioned":118},"This interventional study plans to enroll 3000 participants and compares two different approaches to oxygen administration.","completed","Personalized Oxygen Targets for Acute Respiratory Failure","This study is looking at how different ways of giving oxygen to patients with acute respiratory failure (severe breathing problems) affect their recovery. You might be eligible if you are 18 or older, are in a participating hospital unit, and are on a breathing machine (invasive mechanical ventilation). The study compares two approaches: one where doctors, nurses, and respiratory therapists use a personalized oxygen target predicted to be best for you, and another where they decide on oxygen levels as they normally would. The main goal is to see if one approach leads to fewer deaths in the hospital within 28 days.","Participants will be followed from randomization until hospital discharge or 28 days after randomization, whichever comes first.",102,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]