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.

Clinical Snapshot

Key Findings

• P Value: Not yet available - protocol stage

• Effect Size: Not yet available - protocol stage

• Primary Outcome: Ventilator-free days to day 30 (protocol stage - results pending)

• Nnt Or Sensitivity: Not yet available - protocol stage

• Confidence Interval: Not yet available - protocol stage

Clinical Application

High feasibility given EHR-embedded design and multimodal educational approach that can be adapted to various ICU settings Highly relevant to Australian ICUs - oxygen therapy protocols align with ANZICS guidelines, EHR integration feasible across public and private hospitals, intervention targets common ICU practice variation Adult ICU patients requiring invasive mechanical ventilation in academic and community hospital settings

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. TRIAL REGISTRATION NUMBER: NCT06501118.

References

1. 1.Sottile, P. D., Mikkelsen, M. E., Peterson, R. A., McGrath, M., Carlson, N., Higgins, C., Clinton, M. I., Barbour, A., Kautz, S. V., Kwan, B. M., West, S., Ginde, A. A., & Aggarwal, N. (2026). 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. BMJ Open. https://doi.org/10.1136/bmjopen-2025-110023