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Statistical analysis plan for the Strategy to Avoid Excessive Oxygen using Autonomous Oxygen Titration Intervention (SAVE-O2 AI) trial: protocol.

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Title: Statistical analysis plan for the Strategy to Avoid Excessive Oxygen using Autonomous Oxygen Titration Intervention (SAVE-O2 AI) trial: protocol.
Authors: Douin DJ; Department of Anesthesiology, University of Colorado School of Medicine, Aurora, Colorado, USA David.Douin@cuanschutz.edu., Rice JD; Department of Biostatistics, University of Michigan School of Public Health, Ann Arbor, Michigan, USA., Xiao M; Department of Biostatistics and Informatics, Colorado School of Public Health, Aurora, Colorado, USA., Beaty L; Department of Biostatistics and Informatics, Colorado School of Public Health, Aurora, Colorado, USA., Guo C; Department of Biostatistics and Informatics, Colorado School of Public Health, Aurora, Colorado, USA., Withers C; Department of Emergency Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA., Sullivan A; Department of Emergency Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA., Anderson EL; Department of Emergency Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA., Cheng AC; Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, Tennessee, USA., Banasiewicz MK; Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, Tennessee, USA., Semler MW; Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.; Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, Tennessee, USA., Lloyd BD; Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, Tennessee, USA.; Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA., Maiga A; Division of Acute Care Surgery, Department of Surgery, Vanderbilt University Medical Center, Nashville, Tennessee, USA., Gibbs KW; Section of Pulmonary, Critical Care, Allergy, and Immunologic Disease, Department of Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA., Stettler GR; Department of Surgery, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA., Khan A; Department of Medicine, Division of Pulmonary and Critical Care Medicine, Oregon Health & Science University School of Medicine, Portland, Oregon, USA., Sally MB; Department of Surgery, Oregon Health & Science University School of Medicine, Portland, Oregon, USA., Wright FL; Department of Surgery, University of Colorado School of Medicine, Aurora, Colorado, USA., Aggarwal N; Department of Medicine, Division of Pulmonary Sciences and Critical Care Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA., Bebarta VS; Department of Emergency Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.; Center for COMBAT Research, University of Colorado School of Medicine, Aurora, Colorado, USA., Ginde AA; Department of Emergency Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.; Center for COMBAT Research, University of Colorado School of Medicine, Aurora, Colorado, USA.
Corporate Authors: SAVE-O2 AI Investigators
Source: BMJ open [BMJ Open] 2026 Jan 28; Vol. 16 (1), pp. e110739. Date of Electronic Publication: 2026 Jan 28.
Publication Type: Journal Article; Clinical Trial Protocol
Journal Info: Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE
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  Data: <searchLink fieldCode="AU" term="%22Douin+DJ%22">Douin DJ</searchLink>; Department of Anesthesiology, University of Colorado School of Medicine, Aurora, Colorado, USA David.Douin@cuanschutz.edu.<br /><searchLink fieldCode="AU" term="%22Rice+JD%22">Rice JD</searchLink>; Department of Biostatistics, University of Michigan School of Public Health, Ann Arbor, Michigan, USA.<br /><searchLink fieldCode="AU" term="%22Xiao+M%22">Xiao M</searchLink>; Department of Biostatistics and Informatics, Colorado School of Public Health, Aurora, Colorado, USA.<br /><searchLink fieldCode="AU" term="%22Beaty+L%22">Beaty L</searchLink>; Department of Biostatistics and Informatics, Colorado School of Public Health, Aurora, Colorado, USA.<br /><searchLink fieldCode="AU" term="%22Guo+C%22">Guo C</searchLink>; Department of Biostatistics and Informatics, Colorado School of Public Health, Aurora, Colorado, USA.<br /><searchLink fieldCode="AU" term="%22Withers+C%22">Withers C</searchLink>; Department of Emergency Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.<br /><searchLink fieldCode="AU" term="%22Sullivan+A%22">Sullivan A</searchLink>; Department of Emergency Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.<br /><searchLink fieldCode="AU" term="%22Anderson+EL%22">Anderson EL</searchLink>; Department of Emergency Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.<br /><searchLink fieldCode="AU" term="%22Cheng+AC%22">Cheng AC</searchLink>; Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.<br /><searchLink fieldCode="AU" term="%22Banasiewicz+MK%22">Banasiewicz MK</searchLink>; Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.<br /><searchLink fieldCode="AU" term="%22Semler+MW%22">Semler MW</searchLink>; Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.; Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, Tennessee, USA.<br /><searchLink fieldCode="AU" term="%22Lloyd+BD%22">Lloyd BD</searchLink>; Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, Tennessee, USA.; Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.<br /><searchLink fieldCode="AU" term="%22Maiga+A%22">Maiga A</searchLink>; Division of Acute Care Surgery, Department of Surgery, Vanderbilt University Medical Center, Nashville, Tennessee, USA.<br /><searchLink fieldCode="AU" term="%22Gibbs+KW%22">Gibbs KW</searchLink>; Section of Pulmonary, Critical Care, Allergy, and Immunologic Disease, Department of Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.<br /><searchLink fieldCode="AU" term="%22Stettler+GR%22">Stettler GR</searchLink>; Department of Surgery, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.<br /><searchLink fieldCode="AU" term="%22Khan+A%22">Khan A</searchLink>; Department of Medicine, Division of Pulmonary and Critical Care Medicine, Oregon Health & Science University School of Medicine, Portland, Oregon, USA.<br /><searchLink fieldCode="AU" term="%22Sally+MB%22">Sally MB</searchLink>; Department of Surgery, Oregon Health & Science University School of Medicine, Portland, Oregon, USA.<br /><searchLink fieldCode="AU" term="%22Wright+FL%22">Wright FL</searchLink>; Department of Surgery, University of Colorado School of Medicine, Aurora, Colorado, USA.<br /><searchLink fieldCode="AU" term="%22Aggarwal+N%22">Aggarwal N</searchLink>; Department of Medicine, Division of Pulmonary Sciences and Critical Care Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.<br /><searchLink fieldCode="AU" term="%22Bebarta+VS%22">Bebarta VS</searchLink>; Department of Emergency Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.; Center for COMBAT Research, University of Colorado School of Medicine, Aurora, Colorado, USA.<br /><searchLink fieldCode="AU" term="%22Ginde+AA%22">Ginde AA</searchLink>; Department of Emergency Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.; Center for COMBAT Research, University of Colorado School of Medicine, Aurora, Colorado, USA.
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