Abstract
Importance 背景
The optimal approach to airway management during out-of-hospital cardiac arrest is unknown.
院外心跳骤停时气管管理最佳方法尚属未知
Objective 目的
To determine whether a supraglottic airway device (SGA) is superior to tracheal intubation (TI) as the initial advanced airway management strategy in adults with nontraumatic out-of-hospital cardiac arrest.
明确声门上气道装置(SGA)作为非创伤性院外心跳骤停患者高级气道管理策略是否优于气管插管(TI)。
Design, Setting, and Participants 设计，场景与研究人群
Multicenter, cluster randomized clinical trial of paramedics from 4 ambulance services in England responding to emergencies for approximately 21 million people. Patients aged 18 years or older who had a nontraumatic out-of-hospital cardiac arrest and were treated by a participating paramedic were enrolled automatically under a waiver of consent between June 2015 and August 2017; follow-up ended in February 2018.
多中心、群组随机临床试验，参研单位包括英格兰4个急救中心的医疗辅助人员，负责大约2100万人的急救服务。2015年6月至2017年8月期间，且接受参研单位医疗辅助人员治疗的18岁以上非创伤性院外心跳骤停患者自动入选研究，免除知情同意；2018年2月随访结束。
Interventions 干预措施
Paramedics were randomized 1:1 to use TI (764 paramedics) or SGA (759 paramedics) as their initial advanced airway management strategy.
医疗辅助人员按照1:1的比例随机分为TI（764名医疗辅助人员）或SGA（759名医疗辅助人员）作为初始高级气道管理策略。
Main Outcomes and Measures 主要预后指标
The primary outcome was modified Rankin Scale score at hospital discharge or 30 days after out-of-hospital cardiac arrest, whichever occurred sooner. Modified Rankin Scale score was divided into 2 ranges: 0-3 (good outcome) or 4-6 (poor outcome; 6 = death). Secondary outcomes included ventilation success, regurgitation, and aspiration.
主要预后终点为出院时或院外心跳骤停后30天改良Rankin评分。改良Rankin评分分为0-3分（预后良好）或4-6分（预后不佳；6=死亡）。次要预后指标包括成功通气，返流和误吸。
Results 结果
A total of 9296 patients (4886 in the SGA group and 4410 in the TI group) were enrolled (median age, 73 years; 3373 were women [36.3%]), and the modified Rankin Scale score was known for 9289 patients. In the SGA group, 311 of 4882 patients (6.4%) had a good outcome (modified Rankin Scale score range, 0-3) vs 300 of 4407 patients (6.8%) in the TI group (adjusted risk difference [RD], −0.6% [95% CI, −1.6% to 0.4%]). Initial ventilation was successful in 4255 of 4868 patients (87.4%) in the SGA group compared with 3473 of 4397 patients (79.0%) in the TI group (adjusted RD, 8.3% [95% CI, 6.3% to 10.2%]). However, patients randomized to receive TI were less likely to receive advanced airway management (3419 of 4404 patients [77.6%] vs 4161 of 4883 patients [85.2%] in the SGA group). Two of the secondary outcomes (regurgitation and aspiration) were not significantly different between groups (regurgitation: 1268 of 4865 patients [26.1%] in the SGA group vs 1072 of 4372 patients [24.5%] in the TI group; adjusted RD, 1.4% [95% CI, −0.6% to 3.4%]; aspiration: 729 of 4824 patients [15.1%] vs 647 of 4337 patients [14.9%], respectively; adjusted RD, 0.1% [95% CI, −1.5% to 1.8%]).
研究共纳入9296 名患者 (SGA组4886名，TI组4410名）（中位年龄73岁；3373名女性[36.3%]），9289名患者有改良Rankin评分资料。在SGA组，4882名患者中311名(6.4%)预后良好（改良Rankin评分0-3），TI组4407名患者中300名(6.8%)患者预后良好（校正后风险差异[RD], −0.6% [95% CI, −1.6% to 0.4%]）。SGA组4868名患者中4255名 (87.4%) 初始通气成功，TI组4397名患者中3473名(79.0%)初始通气成功(校正RD, 8.3% [95% CI, 6.3% to 10.2%])。然而，TI组患者更少接受高级气道管理（4404名患者中3419名 [77.6%] vs SGA组4883名患者中4161名 [85.2%]）。次要预后指标中2项（返流和误吸）在两组间无显著差异（返流：SGA组4865名患者中的1268名 [26.1%] vs TI组4372名患者中的1072名 [24.5%]；校正RD, 1.4% [95% CI, −0.6% to 3.4%]；误吸：分别为 4824 名患者中729名 [15.1%] vs 4337名患者中647名 [14.9%]；校正RD, 0.1% [95% CI, −1.5% to 1.8%]）。
Conclusions and Relevance 结论与意义
Among patients with out-of-hospital cardiac arrest, randomization to a strategy of advanced airway management with a supraglottic airway device compared with tracheal intubation did not result in a favorable functional outcome at 30 days.
对于院外心跳骤停的患者，与气管插管相比，采用声门上气道装置进行高级气道管理，并不改善30天良好功能预后比例。
Trial Registration 研究注册
ISRCTN Identifier: 08256118
