Department of Emergency and Critical Care Medicine, Keio University School of Medicine, Shinjuku, Tokyo, Japan
Department of Emergency and Critical Care Medicine, Osaka Medical and Pharmaceutical University, Takatsuki, Osaka, Japan.
BMJ Open. 2023 Sep 15;13(9):e074475. doi: 10.1136/bmjopen-2023-074475.
Cardiac arrest is a critical condition, and patients often experience postcardiac arrest syndrome (PCAS) even after the return of spontaneous circulation (ROSC). Administering a restricted amount of oxygen in the early phase after ROSC has been suggested as a potential therapy for PCAS; however, the optimal target for arterial partial pressure of oxygen or peripheral oxygen saturation (SpO) to safely and effectively reduce oxygen remains unclear. Therefore, we aimed to validate the efficacy of restricted oxygen treatment with 94%-95% of the target SpO during the initial 12 hours after ROSC for patients with PCAS.
ER-OXYTRAC (early restricted oxygen therapy after resuscitation from cardiac arrest) is a nationwide, multicentre, pragmatic, single-blind, stepped-wedge cluster randomised controlled trial targeting cases of non-traumatic cardiac arrest. This study includes adult patients with out-of-hospital or in-hospital cardiac arrest who achieved ROSC in 39 tertiary centres across Japan, with a target sample size of 1000. Patients whose circulation has returned before hospital arrival and those with cardiac arrest due to intracranial disease or intoxication are excluded. Study participants are assigned to either the restricted oxygen (titration of a fraction of inspired oxygen with 94%-95% of the target SpO) or the control (98%-100% of the target SpO) group based on cluster randomisation per institution. The trial intervention continues until 12 hours after ROSC. Other treatments for PCAS, including oxygen administration later than 12 hours, can be determined by the treating physicians. The primary outcome is favourable neurological function, defined as cerebral performance category 1-2 at 90 days after ROSC, to be compared using an intention-to-treat analysis.
This study has been approved by the Institutional Review Board at Keio University School of Medicine (approval number: 20211106). Written informed consent will be obtained from all participants or their legal representatives. Results will be disseminated via publications and presentations.
UMIN Clinical Trials Registry (UMIN000046914).
心脏骤停是一种危急情况，即使自主循环恢复（ROSC）后，患者通常仍会经历心脏骤停后综合征（PCAS）。有研究建议，在 ROSC 后早期给予限制氧气量可能是治疗 PCAS 的一种潜在疗法；然而，安全有效地降低氧分压或外周血氧饱和度（SpO）的最佳目标仍不清楚。因此，我们旨在验证 ROSC 后 12 小时内将目标 SpO 维持在 94%-95%的限制氧治疗对 PCAS 患者的疗效。
ER-OXYTRAC（心脏骤停复苏后早期限制氧治疗）是一项针对非创伤性心脏骤停病例的全国性、多中心、实用、单盲、阶梯式楔形集群随机对照试验。该研究纳入了来自日本 39 家三级中心的成人院外或院内心脏骤停患者，目标样本量为 1000 例。本研究排除了循环在到达医院前已恢复的患者以及因颅内疾病或中毒导致心脏骤停的患者。根据每个机构的集群随机分组，将研究参与者分配至限制氧（目标 SpO 的 94%-95%的吸氧分数滴定）或对照组（目标 SpO 的 98%-100%）。试验干预持续到 ROSC 后 12 小时。PCAS 的其他治疗，包括 12 小时后开始的氧气治疗，可由治疗医生决定。主要结局是 90 天后 ROSC 的神经功能良好，定义为脑功能分类 1-2，采用意向治疗分析进行比较。
本研究已获得庆应义塾大学医学院机构审查委员会的批准（批准号：20211106）。将从所有参与者或其法定代表处获得书面知情同意。研究结果将通过发表文章和演讲进行传播。
UMIN 临床试验注册（UMIN000046914）。
