20241224-孙骎-Early Restrictive vs Liberal Oxygen for Trauma Patients：The TRAUMOX2 Randomized Clinical Trial

早期保守vs.开放氧疗对创伤患者的影响：TRAUMOX2随机

对照研究

Early Restrictive vs Liberal Oxygen for Trauma Patients：The TRAUMOX2 Randomized Clinical Trial

Tobias Arleth, MD; Josefine Baekgaard, MD, PhD; Volkert Siersma, PhD; Andreas Creutzburg, MD; Felicia Dinesen, MD; Oscar Rosenkrantz, MD; Johan Heiberg, MD, PhD, DMSc; Dan Isbye, MD, PhD; Søren Mikkelsen, MD, PhD; Peter M. Hansen, MD; Stine T. Zwisler, MD, PhD; Søren Darling, MD; Louise B. Petersen, MD; Maria C. R. Mørkeberg, MD; Mikkel Andersen, MD, PhD; Christian Fenger-Eriksen, MD, PhD; Peder T. Bach, MD; Mark G. Van Vledder, MD, PhD; Esther M. M. Van Lieshout, PhD, MSc; Niki A. Ottenhof, MD, PhD; Iscander M. Maissan, MD, PhD; Dennis Den Hartog, MD, PhD; Wolf E. Hautz, MD; Dominik A. Jakob, MD; Manuela Iten, MD; Matthias Haenggi, MD; Roland Albrecht, MD; Jochen Hinkelbein, MD; Markus Klimek, MD, PhD; Lars S. Rasmussen, MD, PhD, DMSc; Jacob Steinmetz, MD, PhD; for the TRAUMOX2 Trial Group

JAMA. 2025 Feb 11;333(6):479-489. doi: 10.1001/jama.2024.25786.

Abstract

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

研究背景：对于所有重度创伤患者，早期补充氧气被推荐，但过度使用氧气治疗与死亡风险和呼吸并发症的增加相关。

研究目的：确定与开放性氧疗相比，早期保守性氧疗策略是否能减少成人创伤患者的死亡和/或重大呼吸并发症。

研究设计、地点与参与者：本随机对照试验招募了直接转运至医院的成人创伤患者，启动了全创伤团队激活，预计住院时间不少于24小时，研究时间为2021年12月7日至2023年9月12日。该多中心试验在丹麦、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。主要结局由麻醉和重症医学领域的医学专家评估，且他们对随机分组情况保持盲法。

干预措施：在院前设置或创伤中心入院时，患者按1:1的比例随机分配到保守性氧疗组（动脉血氧饱和度目标94%）（n = 733）或开放性氧疗组（每分钟12-15 L氧气或吸入氧气分数为0.6-1.0）（n = 724），持续8小时。

主要结局与测量指标：主要结局是30天内死亡和/或重大呼吸并发症的复合发生率。两项关键的次要结局——30天内的死亡和重大呼吸并发症——分别单独评估。

研究结果：在1979名随机分配的患者中，1508名完成了试验（中位年龄[四分位间距]为50 [31-65]岁；73%为男性；中位创伤严重度评分为14 [9-22]）。在30天内，保守性氧疗组733名患者中有118人（16.1%）发生死亡和/或重大呼吸并发症，而开放性氧疗组724名患者中有121人（16.7%）发生死亡和/或重大呼吸并发症（比值比为1.01 [95% CI, 0.75至1.37]；P = 0.94；绝对差异为0.56个百分点 [95% CI, -2.70至3.82]）。两组在复合结局的每个组成部分之间未见显著差异。两组的不良事件和严重不良事件相似，唯一的例外是保守性氧疗组的肺不张发生率低于开放性氧疗组（27.6% vs 34.7%）。

结论与意义：对于成人创伤患者，与开放性氧疗策略相比，早期保守性氧疗策略在院前设置或创伤中心入院后实施8小时，并未显著减少30天内死亡和/或重大呼吸并发症。

(孙骎 供稿)