Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
Ambulance Victoria, Melbourne, Victoria, Australia.
JAMA. 2022 Nov 8;328(18):1818-1826. doi: 10.1001/jama.2022.17701.
The administration of a high fraction of oxygen following return of spontaneous circulation in out-of-hospital cardiac arrest may increase reperfusion brain injury.
To determine whether targeting a lower oxygen saturation in the early phase of postresuscitation care for out-of-hospital cardiac arrest improves survival at hospital discharge.
DESIGN, SETTING, AND PARTICIPANTS: This multicenter, parallel-group, randomized clinical trial included unconscious adults with return of spontaneous circulation and a peripheral oxygen saturation (Spo2) of at least 95% while receiving 100% oxygen. The trial was conducted in 2 emergency medical services and 15 hospitals in Victoria and South Australia, Australia, between December 11, 2017, and August 11, 2020, with data collection from ambulance and hospital medical records (final follow-up date, August 25, 2021). The trial enrolled 428 of a planned 1416 patients.
Patients were randomized by paramedics to receive oxygen titration to achieve an oxygen saturation of either 90% to 94% (intervention; n = 216) or 98% to 100% (standard care; n = 212) until arrival in the intensive care unit.
The primary outcome was survival to hospital discharge. There were 9 secondary outcomes collected, including hypoxic episodes (Spo2 <90%) and prespecified serious adverse events, which included hypoxia with rearrest.
The trial was stopped early due to the COVID-19 pandemic. Of the 428 patients who were randomized, 425 were included in the primary analysis (median age, 65.5 years; 100 [23.5%] women) and all completed the trial. Overall, 82 of 214 patients (38.3%) in the intervention group survived to hospital discharge compared with 101 of 211 (47.9%) in the standard care group (difference, -9.6% [95% CI, -18.9% to -0.2%]; unadjusted odds ratio, 0.68 [95% CI, 0.46-1.00]; P = .05). Of the 9 prespecified secondary outcomes collected during hospital stay, 8 showed no significant difference. A hypoxic episode prior to intensive care was observed in 31.3% (n = 67) of participants in the intervention group and 16.1% (n = 34) in the standard care group (difference, 15.2% [95% CI, 7.2%-23.1%]; OR, 2.37 [95% CI, 1.49-3.79]; P < .001).
Among patients achieving return of spontaneous circulation after out-of-hospital cardiac arrest, targeting an oxygen saturation of 90% to 94%, compared with 98% to 100%, until admission to the intensive care unit did not significantly improve survival to hospital discharge. Although the trial is limited by early termination due to the COVID-19 pandemic, the findings do not support use of an oxygen saturation target of 90% to 94% in the out-of-hospital setting after resuscitation from cardiac arrest.
ClinicalTrials.gov Identifier: NCT03138005.
在院外心脏骤停自主循环恢复后给予高分数的氧气可能会增加再灌注脑损伤。
确定在院外心脏骤停复苏后早期护理中靶向较低的氧饱和度是否可以提高出院时的生存率。
设计、地点和参与者：这是一项多中心、平行组、随机临床试验，纳入了无意识的成年人，这些成年人在接受 100%氧气时具有自主循环恢复和外周血氧饱和度（Spo2）至少 95%。该试验于 2017 年 12 月 11 日至 2020 年 8 月 11 日在澳大利亚维多利亚州和南澳大利亚州的 2 个紧急医疗服务和 15 家医院进行，从救护车和医院病历中收集数据（最后随访日期为 2021 年 8 月 25 日）。该试验计划招募 1416 名患者中的 428 名，实际招募了 428 名。
患者由护理人员随机分配接受氧气滴定，以达到氧饱和度为 90%至 94%（干预组；n=216）或 98%至 100%（标准护理组；n=212），直到进入重症监护病房。
主要结局是出院时的生存率。共收集了 9 个次要结局，包括缺氧发作（Spo2 <90%）和预先指定的严重不良事件，包括伴有再停搏的缺氧。
由于 COVID-19 大流行，该试验提前停止。在随机分配的 428 名患者中，有 425 名患者纳入主要分析（中位数年龄为 65.5 岁；100[23.5%]名女性），所有患者均完成了试验。总的来说，干预组中有 214 名患者（38.3%）存活至出院，而标准护理组中有 211 名患者（47.9%）存活至出院（差异，-9.6%[95%CI，-18.9%至-0.2%]；未调整的优势比，0.68[95%CI，0.46-1.00]；P=0.05）。在住院期间收集的 9 个预先指定的次要结局中，有 8 个没有显著差异。在干预组中，有 31.3%（n=67）的患者在进入重症监护室之前出现了缺氧发作，而在标准护理组中，有 16.1%（n=34）的患者出现了缺氧发作（差异，15.2%[95%CI，7.2%-23.1%]；比值比，2.37[95%CI，1.49-3.79]；P < 0.001）。
在院外心脏骤停后实现自主循环恢复的患者中，与 98%至 100%相比，目标氧饱和度为 90%至 94%，直到进入重症监护室，并没有显著提高出院时的生存率。尽管该试验因 COVID-19 大流行而提前终止，但这些发现不支持在心脏骤停复苏后在院外环境中使用 90%至 94%的氧饱和度目标。
ClinicalTrials.gov 标识符：NCT03138005。
