August 28, 2018
Abstract
Importance 背景
Emergency medical services (EMS) commonly perform endotracheal intubation (ETI) or insertion of supraglottic airways, such as the laryngeal tube (LT), on patients with out-of-hospital cardiac arrest (OHCA). The optimal method for OHCA advanced airway management is unknown.
对于院外心跳骤停(OHCA)患者，急救中心(EMS)常常进行气管插管(ETI)或置入声门上气道，如喉罩(LT)。但是，OHCA时高级气道管理的适宜方法尚不清楚。
Objective 目的
To compare the effectiveness of a strategy of initial LT insertion vs initial ETI in adults with OHCA.
比较初始置入LT与ETI对成年OHCA患者的有效性。
Design, Setting, and Participants 设计，场景及研究人群
Multicenter pragmatic cluster-crossover clinical trial involving EMS agencies from the Resuscitation Outcomes Consortium. The trial included 3004 adults with OHCA and anticipated need for advanced airway management who were enrolled from December 1, 2015, to November 4, 2017. The final date of follow-up was November 10, 2017.
多中心、实效性、群组交叉临床试验，纳入Resuscitation Outcomes Consortium的EMS单位。2015年12月1日至2017年11月4日期间，试验纳入3004名预期需要高级气道管理的OHCA成年患者。随访最后日期为2017年11月10日。
Interventions 干预措施
Twenty-seven EMS agencies were randomized in 13 clusters to initial airway management strategy with LT (n = 1505 patients) or ETI (n = 1499 patients), with crossover to the alternate strategy at 3- to 5-month intervals.
27个EMS单位被随机分为13个群组，即LT (n = 1505) 或 ETI (n = 1499) 初始气管管理策略，每3-5个月交叉到另一种策略。
Main Outcomes and Measures 主要预后指标
The primary outcome was 72-hour survival. Secondary outcomes included return of spontaneous circulation, survival to hospital discharge, favorable neurological status at hospital discharge (Modified Rankin Scale score ≤3), and key adverse events.
主要预后终点为72小时生存率。次要预后终点包括自主循环恢复，出院存活率，出院时神经系统功能良好（改良Rankin评分≤3）以及重要不良事件。
Results 结果
Among 3004 enrolled patients (median [interquartile range] age, 64 [53-76] years, 1829 [60.9%] men), 3000 were included in the primary analysis. Rates of initial airway success were 90.3% with LT and 51.6% with ETI. Seventy-two hour survival was 18.3% in the LT group vs 15.4% in the ETI group (adjusted difference, 2.9% [95% CI, 0.2%-5.6%]; P = .04). Secondary outcomes in the LT group vs ETI group were return of spontaneous circulation (27.9% vs 24.3%; adjusted difference, 3.6% [95% CI, 0.3%-6.8%]; P = .03); hospital survival (10.8% vs 8.1%; adjusted difference, 2.7% [95% CI, 0.6%-4.8%]; P = .01); and favorable neurological status at discharge (7.1% vs 5.0%; adjusted difference, 2.1% [95% CI, 0.3%-3.8%]; P = .02). There were no significant differences in oropharyngeal or hypopharyngeal injury (0.2% vs 0.3%), airway swelling (1.1% vs 1.0%), or pneumonia or pneumonitis (26.1% vs 22.3%).
在入选的3004名患者（ 中位年龄 [四分位区间]，64 [53-76] 岁，1829名 [60.9%] 男性）中，3000名纳入最后分析。初始人工气道成功率为LT组90.3%，ETI组51.6%。LT组72小时生存率为18.3%，ETI组为15.4%（校正后差异，2.9%[95% CI, 0.2%-5.6%]；P = .04）。LT组与ETI组次要预后指标的比较，自主循环恢复(27.9% vs 24.3%; 校正后差异, 3.6% [95% CI, 0.3%-6.8%]; P = .03)；住院存活率 (10.8% vs 8.1%; 校正后差异, 2.7% [95% CI, 0.6%-4.8%]; P = .01)；出院时神经系统功能良好(7.1% vs 5.0%; 校正后差异, 2.1% [95% CI, 0.3%-3.8%]; P = .02)。两组患者口咽部或下咽部损伤(0.2% vs 0.3%)，气道水肿 (1.1% vs 1.0%)，或肺炎/肺泡炎 (26.1% vs 22.3%)无显著差异。
Conclusions and Relevance 结论和意义
Among adults with OHCA, a strategy of initial LT insertion was associated with significantly greater 72-hour survival compared with a strategy of initial ETI. These findings suggest that LT insertion may be considered as an initial airway management strategy in patients with OHCA, but limitations of the pragmatic design, practice setting, and ETI performance characteristics suggest that further research is warranted.
对于OHCA成年患者，与初始ETI相比，初始置入LT的策略伴随72小时生存率显著改善。这些发现提示，置入LT可以作为OHCA患者初始气道管理的策略，但本研究的局限性（实效性设计，实施场景，以及ETI操作特点等）提示需要进一步研究。
Trial Registration 试验注册
ClinicalTrials.gov Identifier: NCT02419573
