Effect of a Strategy of a Supraglottic Airway Device vs Tracheal Intubation During Out-of-Hospital Cardiac Arrest on Functional Outcome The AIRWAYS-2 Randomized Clinical Trial
Effect of a Strategy of a Supraglottic Airway Device vs Tracheal Intubation During Out-of-Hospital Cardiac Arrest on Functional Outcome The AIRWAYS-2 Randomized Clinical Trial
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DOI：
10.1001/jama.2018.11597
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发表时间：
2018-08-28
影响因子：
120.7
通讯作者：
Rogers, Chris A.
中科院分区：
文献类型：
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作者：
Benger, Jonathan R.;Kirby, Kim;Rogers, Chris A.
重要性在院外心脏骤停期间气道管理的最佳方法尚不清楚。目的确定声门上气道装置（SGA）作为非创伤性院外心脏骤停成人的初始高级气道管理策略是否上级气管插管（TI）。设计、设置和参与者多中心，来自英格兰4个救护车服务的护理人员为大约2100万人应对紧急情况的群集随机临床试验。在2015年6月至2017年8月期间，年龄在18岁或以上的非创伤性院外心脏骤停并接受参与护理人员治疗的患者在放弃同意的情况下自动入组;随访于2018年2月结束。干预护理人员被随机1：1使用TI（764护理人员）或SGA（759护理人员）作为其最初的先进的气道managementstrategy.Main结局和措施的主要结果是修改后的兰金量表评分在出院或30天后，院外心脏骤停，以较早发生。改良兰金量表评分分为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、反流和抽吸。结果：共纳入9296例患者（SGA组4886例，TI组4410例）（中位年龄73岁; 3373例为女性[36.3%]），9289例患者的改良兰金量表评分已知。SGA组4882例患者中有311例（6.4%）结局良好（改良兰金量表评分范围，0-3），TI组4407例患者中有300例（6.8%）结局良好（校正风险差[RD]，-0.6%<$95% CI，-1.6%至0.4%]）。SGA组4868例患者中有4255例（87.4%）初始通气成功，TI组4397例患者中有3473例（79.0%）初始通气成功（调整后RD，8.3%[95% CI，6.3%-10.2%]）。然而，随机接受TI的患者接受高级气道管理的可能性较低（SGA组4404例患者中的3419例[77.6%] vs 4883例患者中的4161例[85.2%]）。两个次要结局（反流和误吸）在组间无显著差异（返流：SGA组1268/4865例患者[26.1%] vs TI组1072/4372例患者[24.5%];调整后的RD，1.4%[95% CI，-0.6%至3.4%];抽吸：分别为729/4824例患者[15.1%]和647/4337例患者[14.9%];校正的RD，0.1%[95%CI，-1.5%至1.8%]）。结论和相关性在院外心脏骤停的患者中，与气管插管相比，随机采用声门上气道装置进行高级气道管理的策略在30天时没有产生有利的功能结局。
IMPORTANCE The optimal approach to airway management during out-of-hospital cardiac arrest is unknown.OBJECTIVE 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. INTERVENTIONS Paramedics were randomized 1: 1 to use TI (764 paramedics) or SGA (759 paramedics) as their initial advanced airway management strategy.MAIN OUTCOMES AND MEASURES 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.RESULTS 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%]).CONCLUSIONS AND RELEVANCE 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.