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院外心脏骤停期间使用i-gel声门上气道装置与气管插管的随机试验(AIRWAYS-2):三个月和六个月时的患者结局

Randomized trial of the i-gel supraglottic airway device versus tracheal intubation during out of hospital cardiac arrest (AIRWAYS-2): Patient outcomes at three and six months.

作者信息

Benger Jonathan R, Lazaroo Michelle J, Clout Madeleine, Voss Sarah, Black Sarah, Brett Stephen J, Kirby Kim, Nolan Jerry P, Reeves Barnaby C, Robinson Maria, Scott Lauren J, Smartt Helena, South Adrian, Taylor Jodi, Thomas Matthew, Wordsworth Sarah, Rogers Chris A

机构信息

University of the West of England, Glenside Campus, Bristol, UK.

Clinical Trials and Evaluation Unit (CTEU), Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK.

出版信息

Resuscitation. 2020 Dec;157:74-82. doi: 10.1016/j.resuscitation.2020.09.026. Epub 2020 Oct 1.

Abstract

AIM

The AIRWAYS-2 cluster randomised controlled trial compared the i-gel supraglottic airway device (SGA) with tracheal intubation (TI) as the first advanced airway management (AAM) strategy used by Emergency Medical Service clinicians (paramedics) treating adult patients with non-traumatic out-of-hospital cardiac arrest (OHCA). It showed no difference between the two groups in the primary outcome of modified Rankin Scale (mRS) score at 30 days/hospital discharge. This paper reports outcomes to 6 months.

METHODS

Paramedics from four ambulance services in England were randomised 1:1 to use an i-gel SGA (759 paramedics) or TI (764 paramedics) as their initial approach to AAM. Adults who had a non-traumatic OHCA and were attended by a participating paramedic were enrolled automatically under a waiver of consent. Survivors were invited to complete questionnaires at three and six months after OHCA. Outcomes were analysed using regression methods.

RESULTS

767/9296 (8.3%) enrolled patients survived to 30 days/hospital discharge and 317/767 survivors (41.3%) consented and were followed-up to six months. No significant differences were found between the two treatment groups in the primary outcome measure (mRS score: 3 months: odds ratio (OR) for good recovery (i-gel/TI, OR) 0.89, 95% CI 0.69-1.14; 6 months OR 0.91, 95% CI 0.71-1.16). EQ-5D-5L scores were also similar between groups and sensitivity analyses did not alter the findings.

CONCLUSION

There were no statistically significant differences between the TI and i-gel groups at three and six months. We therefore conclude that the initially reported finding of no significant difference between groups at 30 days/hospital discharge was sustained when the period of follow-up was extended to six months.

摘要

目的

AIRWAYS - 2整群随机对照试验比较了i - gel声门上气道装置(SGA)与气管插管(TI)作为紧急医疗服务临床医生(护理人员)对非创伤性院外心脏骤停(OHCA)成年患者进行首次高级气道管理(AAM)的策略。结果显示,两组在30天/出院时的改良Rankin量表(mRS)评分这一主要结局上无差异。本文报告至6个月时的结局。

方法

来自英格兰四个救护服务机构的护理人员按1:1随机分组,分别使用i - gel SGA(759名护理人员)或TI(764名护理人员)作为其AAM的初始方法。患有非创伤性OHCA且由参与研究的护理人员救治的成年人在同意豁免的情况下自动入组。邀请幸存者在OHCA发生后的三个月和六个月完成问卷调查。采用回归方法分析结局。

结果

9296名入组患者中有767名(8.3%)存活至30天/出院,317名(41.3%)存活者同意并接受了为期六个月的随访。在主要结局指标方面,两个治疗组之间未发现显著差异(mRS评分:3个月时,良好恢复的比值比(OR)(i - gel/TI,OR)为0.89,95%置信区间为0.69 - 1.14;6个月时OR为0.91,95%置信区间为0.71 - 1.16)。两组之间的EQ - 5D - 5L评分也相似,敏感性分析未改变研究结果。

结论

TI组和i - gel组在三个月和六个月时无统计学显著差异。因此,我们得出结论,当随访期延长至六个月时,最初报告的两组在30天/出院时无显著差异的结果仍然成立。

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