Importance Early administration of supplemental oxygen for all severely injured trauma patients is recommended, but liberal oxygen treatment has been associated with increased risk of death and respiratory complications. Objective To determine whether an early 8-hour restrictive oxygen strategy compared with a liberal oxygen strategy in adult trauma patients would reduce death and/or major respiratory complications. Design, Setting, and Participants This randomized controlled trial enrolled adult trauma patients transferred directly to hospitals, triggering a full trauma team activation with an anticipated hospital stay of a minimum of 24 hours from December 7, 2021, to September 12, 2023. This multicenter trial was conducted at 15 prehospital bases and 5 major trauma centers in Denmark, the Netherlands, and Switzerland. The 30-day follow-up period ended on October 12, 2023. The primary outcome was assessed by medical specialists in anesthesia and intensive care medicine blinded to the randomization. Interventions In the prehospital setting or on trauma center admission, patients were randomly assigned 1:1 to a restrictive oxygen strategy (arterial oxygen saturation target of 94%) (n = 733) or liberal oxygen strategy (12-15 L of oxygen per minute or fraction of inspired oxygen of 0.6-1.0) (n = 724) for 8 hours. Main Outcomes and Measures The primary outcome was a composite of death and/or major respiratory complications within 30 days. The 2 key secondary outcomes, death and major respiratory complications within 30 days, were assessed individually. Results Among 1979 randomized patients, 1508 completed the trial (median [IQR] age, 50 [31-65] years; 73% male; and median Injury Severity Score was 14 [9-22]). Death and/or major respiratory complications within 30 days occurred in 118 of 733 patients (16.1%) in the restrictive oxygen group and 121 of 724 patients (16.7%) in the liberal oxygen group (odds ratio, 1.01 [95% CI, 0.75 to 1.37]; P = .94; absolute difference, 0.56 percentage points [95% CI, -2.70 to 3.82]). No significant differences were found between groups for each component of the composite outcome. Adverse and serious adverse events were similar across groups, with the exception of atelectasis, which was less common in the restrictive oxygen group compared with the liberal oxygen group (27.6% vs 34.7%, respectively). Conclusions and Relevance In adult trauma patients, an early restrictive oxygen strategy compared with a liberal oxygen strategy initiated in the prehospital setting or on trauma center admission for 8 hours did not significantly reduce death and/or major respiratory complications within 30 days. Trial Registration ClinicalTrials.gov Identifier: NCT05146700.

中文翻译：

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创伤患者的早期限制性吸氧与自由吸氧：TRAUMOX2 随机临床试验。


重要性 建议所有严重受伤的创伤患者尽早给予补充氧气，但自由氧疗与死亡和呼吸并发症风险增加有关。目的 确定成年创伤患者早期 8 小时限制性氧疗策略与自由氧疗策略相比是否会减少死亡和/或主要呼吸并发症。设计、设置和参与者 这项随机对照试验招募了直接转移到医院的成年创伤患者，触发了完整的创伤团队启动，预计从 2021 年 12 月 7 日至 2023 年 9 月 12 日住院至少 24 小时。这项多中心试验在丹麦、荷兰和瑞士的 15 个院前基地和 5 个主要创伤中心进行。30 天的随访期于 2023 年 10 月 12 日结束。主要结局由对随机化不知情的麻醉和重症监护医学医学专家评估。干预措施 在院前环境或创伤中心入院时，患者被 1：1 随机分配到限制性氧疗策略（动脉血氧饱和度目标为 94%）（n = 733）或自由氧疗策略（每分钟 12-15 L 氧气或吸入氧浓度为 0.6-1.0）（n = 724），持续 8 小时。主要结局和测量 主要结局是 30 天内死亡和/或主要呼吸系统并发症的复合结局。分别评估 2 个关键的次要结局，即 30 天内的死亡和主要呼吸并发症。结果 在 1979 例随机分组的患者中，1508 例完成了试验 （中位 [IQR] 年龄，50 [31-65] 岁;73% 为男性;中位损伤严重程度评分为 14 [9-22]）。 限制氧疗组 733 例患者中有 118 例 （16.1%） 发生 30 天内死亡和/或主要呼吸并发症，自由氧疗组 724 例患者中有 121 例 （16.7%） 发生死亡和/或主要呼吸并发症（比值比，1.01 [95% CI，0.75-1.37];P = .94;绝对差异，0.56 个百分点 [95% CI，-2.70 至 3.82]）。对于复合结局的每个组成部分，组间未发现显著差异。各组的不良事件和严重不良事件相似，但肺不张除外，与自由吸氧组相比，限制性氧疗组较少见（分别为 27.6% 和 34.7%）。结论和相关性 在成年创伤患者中，与在院前或创伤中心入院 8 小时时开始的自由氧疗策略相比，早期限制氧疗策略在 30 天内没有显着减少死亡和/或主要呼吸并发症。试验注册 ClinicalTrials.gov 标识符： NCT05146700.