University of the West of England, Glenside Campus, Bristol.
South Western Ambulance Service NHS Foundation Trust, Exeter, England.
JAMA. 2018 Aug 28;320(8):779-791. doi: 10.1001/jama.2018.11597.
The optimal approach to airway management during out-of-hospital cardiac arrest is unknown.
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.
DESIGN, SETTING, AND PARTICIPANTS: 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.
Paramedics were randomized 1:1 to use TI (764 paramedics) or SGA (759 paramedics) as their initial advanced airway management strategy.
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.
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%]).
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.
ISRCTN Identifier: 08256118.
院外心脏骤停期间气道管理的最佳方法尚不清楚。
确定在非创伤性院外心脏骤停的成人中,使用声门上气道装置(SGA)作为初始高级气道管理策略是否优于气管插管(TI)。
设计、地点和参与者:多中心、集群随机临床试验,纳入了英格兰 4 家救护车服务机构的 400 名护理人员,为大约 2100 万人提供急救服务。患者年龄在 18 岁或以上,经历了非创伤性院外心脏骤停,由参与的护理人员进行治疗,在 2015 年 6 月至 2017 年 8 月期间,在同意豁免的情况下自动纳入研究;随访于 2018 年 2 月结束。
护理人员被随机分为 1:1 组,分别使用 TI(764 名护理人员)或 SGA(759 名护理人员)作为他们的初始高级气道管理策略。
主要结局是院外心脏骤停后或出院时的改良 Rankin 量表评分,以较早出现的为准。改良 Rankin 量表评分分为 2 个范围:0-3(良好结局)或 4-6(不良结局;6=死亡)。次要结局包括通气成功、反流和误吸。
共有 9296 名患者(SGA 组 4886 名,TI 组 4410 名)入组(中位年龄 73 岁;3373 名为女性[36.3%]),9289 名患者的改良 Rankin 量表评分已知。在 SGA 组中,4882 名患者中有 311 名(6.4%)有良好结局(改良 Rankin 量表评分范围,0-3),而 TI 组中 4407 名患者中有 300 名(6.8%)(调整后的风险差异[RD],-0.6%[95%CI,-1.6%至 0.4%])。在 SGA 组中,4868 名患者中有 4255 名(87.4%)初始通气成功,而 TI 组中 4397 名患者中有 3473 名(79.0%)(调整后的 RD,8.3%[95%CI,6.3%至 10.2%])。然而,接受 TI 治疗的患者更不可能接受高级气道管理(SGA 组中 4404 名患者中有 3419 名[77.6%],而 SGA 组中 4883 名患者中有 4161 名[85.2%])。两个次要结局(反流和误吸)在组间没有显著差异(反流:SGA 组 4865 名患者中有 1268 名[26.1%],TI 组中有 1072 名[24.5%];调整后的 RD,1.4%[95%CI,-0.6%至 3.4%];误吸:SGA 组 4824 名患者中有 729 名[15.1%],TI 组中有 647 名[14.9%],调整后的 RD,0.1%[95%CI,-1.5%至 1.8%])。
在院外心脏骤停患者中,与气管插管相比,使用声门上气道装置进行高级气道管理的策略随机分组并未导致 30 天的良好功能结局。
ISRCTN 标识符:08256118。