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Does a protocolised oxygenation target impact clinical outcomes in mechanically ventilated patients in the intensive care unit across the 10 academic and community hospitals in the UCHealth system? Protocol and statistical analysis plan for an EHR-embedded pragmatic stepped-wedge randomised controlled trial
Journal article   Open access   Peer reviewed

Does a protocolised oxygenation target impact clinical outcomes in mechanically ventilated patients in the intensive care unit across the 10 academic and community hospitals in the UCHealth system? Protocol and statistical analysis plan for an EHR-embedded pragmatic stepped-wedge randomised controlled trial

Peter D Sottile, Mark E Mikkelsen, Ryan A Peterson, Max Mcgrath, Nichole Carlson, Carrie Higgins, Margaret I Clinton, Aaron Barbour, Sarah V Kautz, Bethany M Kwan, …
BMJ open, Vol.16(5), e110023
05/26/2026
DOI: 10.1136/bmjopen-2025-110023
PMCID: PMC13218103
PMID: 42191205
url
https://doi.org/10.1136/bmjopen-2025-110023View
Published (Version of record) Open Access

Abstract

Introduction We designed the Optimising Care in Critically Ill at the UCHealth by Liberalising the Target O₂ in Mechanically ventilated intensive care unit (ICU) Patients to determine the effectiveness of a multimodal educational and electronic health record order panel intervention in limiting occult hypoxaemia and hyperoxaemia in patients receiving invasive mechanical ventilation by targeting a prespecified oxygen saturation (SpO₂ 90%–96%) range. Methods and analysis This trial is a pragmatic electronic health record-embedded, multisite, cluster-randomised, stepped-wedge implementation of a multimodal educational and electronic health record order panel intervention aimed at achieving a standardised intermediate target range of SpO₂ (90%–96%) or partial pressure of oxygen (PaO₂ 60–100 mm Hg) in mechanically ventilated adult patients admitted to the ICU across a 10 hospital health system that includes a large academic centre and smaller community hospitals. The primary endpoint is ventilator-free days to day 30, defined as the number of days alive and not receiving support through invasive mechanical ventilation following the first initiation of invasive mechanical ventilation in a participating ICU during the hospitalisation. Secondary outcomes include a variety of clinical endpoints: hospital-free days to day 30, all-cause mortality to day 90, need for supplemental oxygen at discharge and incidence of occult hypoxaemia and hypoxaemia. We will analyse primary and secondary endpoints using a mixed effects modelling framework, with specific distributions chosen depending on the type of outcome (eg, binary, count, ordinal, time-to-event). Ethics and dissemination Research is performed under a waiver of informed consent for minimal-risk research, as approved by Colorado Multiple Institutional Review Board (24-0065). Results will be disseminated in peer-reviewed publications and at national and international conferences.
 Electronic Health Records Hypoxia Intensive Care Pragmatic Clinical Trial Ventilators, Mechanical

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