JAMA:面罩通气VS气管插管,选哪一个?

摘要

在院外心脏骤停患者的心肺复苏中,面罩通气作为气道管理的方法,与气管插管孰优孰劣?JAMA为您解答。


空白

面罩通气(Bag-mask ventilation, BMV)和气管插管(endotracheal intubation, ETI)都是心脏病患者进行心肺复苏术时进行高级气道管理的手段。相比之下,面罩通气比气管插管的操作技术更为简单一些。那么面罩通气对心脏呼吸骤停患者的神经功能恢复与气管插管相比怎样呢?2018年2月底的JAMA上报道了一则随机对照研究。




研究目的

为了评估在高级气道管理中,面罩通气(BMV)vs 气管插管(ETI)对于患者第28天神经系统功能的生存的非劣效性。



研究设计

患者入组:采取多中心随机临床试验,比较了法国和比利时2043例院外心肺骤停患者的BMV和ETI。患者纳入时间为2015年3月9日至2017年1月2日,并于2017年1月26日结束。

干预措施:参与者被随机分配到BMV(n = 1020)或ETI(n = 1023)的初始气道管理。

主要结局主要终点是第28天时的神经系统功能良好恢复,定义为脑功能1或2级。非劣性边界为1%。次要终点包括入院时的存活率,第28天的存活率,自主循环率以及ETI和BMV的困难或失败率。



结果 

随机分组的2043名患者(平均年龄64.7岁; 665名女性[32%])中,2040名(99.8%)完成了试验。


  • 在入组的人群中, BMV组1018例患者中的44例(4.3%)在第28天时达到了良好的生存功能,ETI组1022例患者中则有43例(4.2%)(差异为0.11%[单侧97.5%CI,-1.64%-∞]; 非劣性P= .11)。

  • 第28天的住院期间存活率(BMT组为294/1018 [28.9%],ETI组为333/1022 [32.6%];差异为-3.7%[95%CI,-7.7%~0.3%])和总体生存率(BMV组为55/1018 [5.4%],ETI组为54/1022 [5.3%];差异为0.1%[95%CI,-1.8%~2.1%])没有显着差异。

  • 并发症包括气道管理困难(BMV组为186/1027 [18.1%],ETI组为134/996 [13.4%];差异为4.7%[95%CI为1.5%~7.9%]; P = .004 );维护失败(BMV组为69/1028 [6.7%],ETI组为21/996 [2.1%];差异为4.6%[95%CI,2.8~6.4%]; P <.001);和胃内容物反流(在BMT组中为156/1027 [15.2%],在ETI组中为75/999 [7.5%];差异为7.7%[95%CI,4.9%~10.4%]; P <0.001 )。在这项研究中,没有得到BMV对第28天神经系统功能恢复优于/不劣于ETI的结果。虽然以往的研究表明BMV的生存率更高,但这些研究可能容易出现偏倚。虽然一些研究采取了控制混杂因素或研究匹配队列的方法,但插管患者的病情可能更严重,导致医生采取了更积极的复苏方法。 因此,目前美国,欧洲和国际复苏综合文件联络委员会的建议是将面罩通气和插管同时作为心脏骤停过程中的气道介入手段(IIb类)。


    原文:

    Importance  

    Bag-mask ventilation (BMV) is a less complex technique than endotracheal intubation (ETI) for airway management during the advanced cardiac life support phase of cardiopulmonary resuscitation of patients with out-of-hospital cardiorespiratory arrest. It has been reported as superior in terms of survival.


    Objectives  

    To assess noninferiority of BMV vs ETI for advanced airway management with regard to survival with favorable neurological function at day 28.


    Design, Settings, and Participants  

    Multicenter randomized clinical trial comparing BMV with ETI in 2043 patients with out-of-hospital cardiorespiratory arrest in France and Belgium. Enrollment occurred from March 9, 2015, to January 2, 2017, and follow-up ended January 26, 2017.


    Intervention  

    Participants were randomized to initial airway management with BMV (n = 1020) or ETI (n = 1023).


    Main Outcomes and Measures  

    The primary outcome was favorable neurological outcome at 28 days defined as cerebral performance category 1 or 2. A noninferiority margin of 1% was chosen. Secondary end points included rate of survival to hospital admission, rate of survival at day 28, rate of return of spontaneous circulation, and ETI and BMV 

    difficulty or failure.


    Results

     Among 2043 patients who were randomized (mean age, 64.7 years; 665 women [32%]), 2040 (99.8%) completed the trial. In the intention-to-treat population, favorable functional survival at day 28 was 44 of 1018 patients (4.3%) in the BMV group and 43 of 1022 patients (4.2%) in the ETI group (difference, 0.11% [1-sided 97.5% CI, −1.64% to infinity]; P for noninferiority = .11). Survival to hospital admission (294/1018 [28.9%] in the BMV group vs 333/1022 [32.6%] in the ETI group; difference, −3.7% [95% CI, −7.7% to 0.3%]) and global survival at day 28 (55/1018 [5.4%] in the BMV group vs 54/1022 [5.3%] in the ETI group; difference, 0.1% [95% CI, −1.8% to 2.1%]) were not significantly different. Complications included difficult airway management (186/1027 [18.1%] in the BMV group vs 134/996 [13.4%] in the ETI group; difference, 4.7% [95% CI, 1.5% to 7.9%]; P = .004), failure (69/1028 [6.7%] in the BMV group vs 21/996 [2.1%] in the ETI group; difference, 4.6% [95% CI, 2.8% to 6.4%]; P < .001), and regurgitation of gastric content (156/1027 [15.2%] in the BMV group vs 75/999 [7.5%] in the ETI group; difference, 7.7% [95% CI, 4.9% to 10.4%]; P < .001).


    Conclusions and Relevance  

    Among patients with out-of-hospital cardiorespiratory arrest, the use of BMV compared with ETI failed to demonstrate noninferiority or inferiority for survival with favorable 28-day neurological function, an inconclusive result. A determination of equivalence or superiority between these techniques requires further research.

    Trial Registration  clinicaltrials.gov Identifier: NCT02327026


    出处:JAMA. 2018;319(8):779-787. doi:10.1001/jama.2018.0156


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