Department of Emergency Medicine, University of Texas Health Science Center at Houston.
Department of Emergency Medicine, University of Alabama at Birmingham.
JAMA. 2018 Aug 28;320(8):769-778. doi: 10.1001/jama.2018.7044.
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.
To compare the effectiveness of a strategy of initial LT insertion vs initial ETI in adults with OHCA.
DESIGN, SETTING, AND PARTICIPANTS: 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.
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.
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.
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%).
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.
ClinicalTrials.gov Identifier: NCT02419573.
重要性：在院外心脏骤停（OHCA）患者中，急救医疗服务（EMS）通常进行气管内插管（ETI）或插入声门上气道，如喉管（LT）。OHCA 高级气道管理的最佳方法尚不清楚。
目的：比较初始 LT 插入与初始 ETI 在 OHCA 成人患者中的有效性。
设计、设置和参与者：这是一项多中心实用集群交叉临床试验，涉及复苏结果联盟的 EMS 机构。该试验纳入了 3004 名预计需要高级气道管理的 OHCA 成年患者，于 2015 年 12 月 1 日至 2017 年 11 月 4 日入组。最终随访日期为 2017 年 11 月 10 日。
干预措施：27 个 EMS 机构被随机分为 13 个集群，采用 LT（n=1505 例患者）或 ETI（n=1499 例患者）初始气道管理策略，每隔 3 至 5 个月进行交叉至替代策略。
主要结局和测量：主要结局为 72 小时生存率。次要结局包括自主循环恢复、出院时存活、出院时神经功能良好（改良 Rankin 量表评分≤3）和主要不良事件。
结果：在 3004 名入组患者（中位[四分位间距]年龄，64[53-76]岁，1829[60.9%]为男性）中，3000 名患者纳入主要分析。LT 组初始气道成功率为 90.3%，ETI 组为 51.6%。LT 组 72 小时生存率为 18.3%，ETI 组为 15.4%（调整差异，2.9%[95%CI，0.2%-5.6%]；P=0.04）。LT 组与 ETI 组的次要结局包括自主循环恢复（27.9% vs 24.3%；调整差异，3.6%[95%CI，0.3%-6.8%]；P=0.03）；住院存活率（10.8% vs 8.1%；调整差异，2.7%[95%CI，0.6%-4.8%]；P=0.01）和出院时神经功能良好（7.1% vs 5.0%；调整差异，2.1%[95%CI，0.3%-3.8%]；P=0.02）。口咽或下咽损伤（0.2% vs 0.3%）、气道肿胀（1.1% vs 1.0%）或肺炎或肺炎（26.1% vs 22.3%）无显著差异。
结论和相关性：在 OHCA 成人患者中，与初始 ETI 策略相比，初始 LT 插入策略与 72 小时生存率显著提高相关。这些发现表明，LT 插入可作为 OHCA 患者初始气道管理策略的一种选择，但实用设计、实践环境和 ETI 性能特征的局限性表明，需要进一步研究。
试验注册：ClinicalTrials.gov 标识符：NCT02419573。
