多中心集群随机、阶梯式实施试验，针对危重症创伤患者的目标性氧合：避免过度供氧策略（SAVE-O2 试验）的研究方案和统计分析计划。
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.
机构信息
Department of Emergency Medicine, University of Colorado School of Medicine, Aurora, CO, USA.
Department of Anesthesiology, University of Colorado School of Medicine, Aurora, CO, USA.
出版信息
Trials. 2021 Nov 8;22(1):784. doi: 10.1186/s13063-021-05688-6.
BACKGROUND
Targeted normoxia (SpO 90-96% or PaO 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.
背景
目标性低氧血症（SpO₂90-96%或 PaO₂60-100mmHg）通过避免潜在的有害性高氧血症，可能有助于危重症患者节约氧气并改善结局。然而，目标性低氧血症对于危重症创伤患者的作用仍不确定。本研究旨在描述 Strategy to Avoid Excessive Oxygen for Critically Ill Trauma Patients（SAVE-O₂）临床试验的研究方案和统计分析计划。
方法
设计、设置和参与者：这是一项多中心集群随机、阶梯式实施试验的方案，评估一种针对危重症创伤患者目标性低氧血症的多模式干预措施的有效性，研究对象为美国 8 家 1 级创伤中心的患者。每个医院将提供实施前（对照组）和实施后（干预组）的数据。所有的医院都将从常规治疗的对照组开始。当医院达到随机分组的过渡时间时，将有一个为期 1 个月的培训期，但不纳入数据收集。培训期结束后，该医院将在整个试验期间处于干预组。
主要结局指标
主要结局指标为无需补充氧气的天数，定义为存活且未使用补充氧气的天数。次要结局指标包括 90 天内院内死亡率、90 天内无住院天数、28 天内无呼吸机天数、达到空气环境的时间、格拉斯哥结局评分（GOS）和接受补充氧气的时间。
讨论
SAVE-O₂ 将确定一种改善目标性低氧血症依从性的多模式干预措施是否能安全减少对危重症创伤患者集中供氧的需求。这些数据将为军事利益相关者提供有关严重受伤战斗人员的氧气需求的信息，同时减少在长期作战伤员护理中的后勤负担。
试验注册
ClinicalTrials.gov NCT04534959。于 2020 年 9 月 1 日注册。
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