A multicenter cluster randomized, stepped wedge implementation trial for targeted normoxia in critically ill trauma patients: study protocol and statistical analysis plan for the Strategy to Avoid Excessive Oxygen (SAVE-O2) trial

Abstract Background Targeted normoxia (SpO2 90–96% or PaO2 60–100 mmHg) may help to conserve oxygen and improve outcomes in critically ill patients by avoiding potentially harmful hyperoxia. However, the role of normoxia for critically ill trauma patients remains uncertain. The objective of this stu...

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Autores principales:	Layne Dylla, David J. Douin, Erin L. Anderson, John D. Rice, Conner L. Jackson, Vikhyat S. Bebarta, Christopher J. Lindsell, Alex C. Cheng, Steven G. Schauer, Adit A. Ginde
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Oxygenation Hyperoxia Trauma Injuries Critical care Intensive care units Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/25211e04f7374b8e967ab3d7ae5c2597
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spelling	oai:doaj.org-article:25211e04f7374b8e967ab3d7ae5c25972021-11-14T12:31:08ZA multicenter cluster randomized, stepped wedge implementation trial for targeted normoxia in critically ill trauma patients: study protocol and statistical analysis plan for the Strategy to Avoid Excessive Oxygen (SAVE-O2) trial10.1186/s13063-021-05688-61745-6215https://doaj.org/article/25211e04f7374b8e967ab3d7ae5c25972021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05688-6https://doaj.org/toc/1745-6215Abstract Background Targeted normoxia (SpO2 90–96% or PaO2 60–100 mmHg) may help to conserve oxygen and improve outcomes in critically ill patients by avoiding potentially harmful hyperoxia. However, the role of normoxia for critically ill trauma patients remains uncertain. The objective of this study is to describe the study protocol and statistical analysis plan for the Strategy to Avoid Excessive Oxygen for Critically Ill Trauma Patients (SAVE-O2) clinical trial. Methods Design, setting, and participants: Protocol for a multicenter cluster randomized, stepped wedge implementation trial evaluating the effectiveness of a multimodal intervention to target normoxia in critically ill trauma patients at eight level 1 trauma centers in the USA. Each hospital will contribute pre-implementation (control) and post-implementation (intervention) data. All sites will begin in the control phase with usual care. When sites reach their randomly assigned time to transition, there will be a one-month training period, which does not contribute to data collection. Following the 1-month training period, the site will remain in the intervention phase for the duration of the trial. Main outcome measures: The primary outcome will be supplemental oxygen-free days, defined as the number of days alive and not on supplemental oxygen. Secondary outcomes include in-hospital mortality to day 90, hospital-free days to day 90, ventilator-free days (VFD) to day 28, time to room air, Glasgow Outcome Score (GOS), and duration of time receiving supplemental oxygen. Discussion SAVE-O2 will determine if a multimodal intervention to improve compliance with targeted normoxia will safely reduce the need for concentrated oxygen for critically injured trauma patients. These data will inform military stakeholders regarding oxygen requirements for critically injured warfighters, while reducing logistical burden in prolonged combat casualty care. Trial registration ClinicalTrials.gov NCT04534959 . Registered September 1, 2020.Layne DyllaDavid J. DouinErin L. AndersonJohn D. RiceConner L. JacksonVikhyat S. BebartaChristopher J. LindsellAlex C. ChengSteven G. SchauerAdit A. GindeBMCarticleOxygenationHyperoxiaTraumaInjuriesCritical careIntensive care unitsMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-10 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Oxygenation Hyperoxia Trauma Injuries Critical care Intensive care units Medicine (General) R5-920
spellingShingle	Oxygenation Hyperoxia Trauma Injuries Critical care Intensive care units Medicine (General) R5-920 Layne Dylla David J. Douin Erin L. Anderson John D. Rice Conner L. Jackson Vikhyat S. Bebarta Christopher J. Lindsell Alex C. Cheng Steven G. Schauer Adit A. Ginde A multicenter cluster randomized, stepped wedge implementation trial for targeted normoxia in critically ill trauma patients: study protocol and statistical analysis plan for the Strategy to Avoid Excessive Oxygen (SAVE-O2) trial
description	Abstract Background Targeted normoxia (SpO2 90–96% or PaO2 60–100 mmHg) may help to conserve oxygen and improve outcomes in critically ill patients by avoiding potentially harmful hyperoxia. However, the role of normoxia for critically ill trauma patients remains uncertain. The objective of this study is to describe the study protocol and statistical analysis plan for the Strategy to Avoid Excessive Oxygen for Critically Ill Trauma Patients (SAVE-O2) clinical trial. Methods Design, setting, and participants: Protocol for a multicenter cluster randomized, stepped wedge implementation trial evaluating the effectiveness of a multimodal intervention to target normoxia in critically ill trauma patients at eight level 1 trauma centers in the USA. Each hospital will contribute pre-implementation (control) and post-implementation (intervention) data. All sites will begin in the control phase with usual care. When sites reach their randomly assigned time to transition, there will be a one-month training period, which does not contribute to data collection. Following the 1-month training period, the site will remain in the intervention phase for the duration of the trial. Main outcome measures: The primary outcome will be supplemental oxygen-free days, defined as the number of days alive and not on supplemental oxygen. Secondary outcomes include in-hospital mortality to day 90, hospital-free days to day 90, ventilator-free days (VFD) to day 28, time to room air, Glasgow Outcome Score (GOS), and duration of time receiving supplemental oxygen. Discussion SAVE-O2 will determine if a multimodal intervention to improve compliance with targeted normoxia will safely reduce the need for concentrated oxygen for critically injured trauma patients. These data will inform military stakeholders regarding oxygen requirements for critically injured warfighters, while reducing logistical burden in prolonged combat casualty care. Trial registration ClinicalTrials.gov NCT04534959 . Registered September 1, 2020.
format	article
author	Layne Dylla David J. Douin Erin L. Anderson John D. Rice Conner L. Jackson Vikhyat S. Bebarta Christopher J. Lindsell Alex C. Cheng Steven G. Schauer Adit A. Ginde
author_facet	Layne Dylla David J. Douin Erin L. Anderson John D. Rice Conner L. Jackson Vikhyat S. Bebarta Christopher J. Lindsell Alex C. Cheng Steven G. Schauer Adit A. Ginde
author_sort	Layne Dylla
title	A multicenter cluster randomized, stepped wedge implementation trial for targeted normoxia in critically ill trauma patients: study protocol and statistical analysis plan for the Strategy to Avoid Excessive Oxygen (SAVE-O2) trial
title_short	A multicenter cluster randomized, stepped wedge implementation trial for targeted normoxia in critically ill trauma patients: study protocol and statistical analysis plan for the Strategy to Avoid Excessive Oxygen (SAVE-O2) trial
title_full	A multicenter cluster randomized, stepped wedge implementation trial for targeted normoxia in critically ill trauma patients: study protocol and statistical analysis plan for the Strategy to Avoid Excessive Oxygen (SAVE-O2) trial
title_fullStr	A multicenter cluster randomized, stepped wedge implementation trial for targeted normoxia in critically ill trauma patients: study protocol and statistical analysis plan for the Strategy to Avoid Excessive Oxygen (SAVE-O2) trial
title_full_unstemmed	A multicenter cluster randomized, stepped wedge implementation trial for targeted normoxia in critically ill trauma patients: study protocol and statistical analysis plan for the Strategy to Avoid Excessive Oxygen (SAVE-O2) trial
title_sort	multicenter cluster randomized, stepped wedge implementation trial for targeted normoxia in critically ill trauma patients: study protocol and statistical analysis plan for the strategy to avoid excessive oxygen (save-o2) trial
publisher	BMC
publishDate	2021
url	https://doaj.org/article/25211e04f7374b8e967ab3d7ae5c2597
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A multicenter cluster randomized, stepped wedge implementation trial for targeted normoxia in critically ill trauma patients: study protocol and statistical analysis plan for the Strategy to Avoid Excessive Oxygen (SAVE-O2) trial

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