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[JAMA在线发表]:比较早期拔管过渡到无创通气与常规脱机对脱离机械通气时间的影响
2018年10月25日 时讯速递, 进展交流 暂无评论

Original Investigation

October 22, 2018

Effect of Protocolized Weaning With Early Extubation to Noninvasive Ventilation vs Invasive Weaning on Time to Liberation From Mechanical Ventilation Among Patients With Respiratory Failure: The Breathe Randomized Clinical Trial

Gavin D. Perkins, Dipesh Mistry, Simon Gates, et al

JAMA. Published online October 22, 2018.

doi:10.1001/jama.2018.13763

Abstract

Importance 背景

In adults in whom weaning from invasive mechanical ventilation is difficult, noninvasive ventilation may facilitate early liberation, but there is uncertainty about its effectiveness in a general intensive care patient population.

对于脱离呼吸机困难等成年患者,无创通气可能有助于早期脱机,但这一策略对于普通ICU患者的疗效尚不明确。

Objective 目的

To investigate among patients with difficulty weaning the effects of protocolized weaning with early extubation to noninvasive ventilation on time to liberation from ventilation compared with protocolized invasive weaning.

对于脱机困难的患者,比较早期拔管过渡到无创通气的方案脱机与有创通气脱机方案的疗效。

Design, Setting, and Participants 设计,场景及研究人群

Randomized, allocation-concealed, open-label, multicenter clinical trial enrolling patients between March 2013 and October 2016 from 41 intensive care units in the UK National Health Service. Follow-up continued until April 2017. Adults who received invasive mechanical ventilation for more than 48 hours and in whom a spontaneous breathing trial failed were enrolled.

这项随机、分配隐藏、开放标签、多中心临床试验于2013年3月至2016年10月在英国NHS的41个ICU进行。随访持续到2017年4月。接受有创机械通气超过48小时且自主呼吸试验失败的患者入选。

Interventions 干预措施

Patients were randomized to receive either protocolized weaning via early extubation to noninvasive ventilation (n = 182) or protocolized standard weaning (continued invasive ventilation until successful spontaneous breathing trial, followed by extubation) (n = 182).

患者接受随机分组,接受方案脱机即早期拔管过渡到无创通气(n = 182),或标准方案脱机(即持续有创通气直至自主呼吸试验成功,随后拔管)(n = 182)。

Main Outcomes and Measures 主要预后指标

Primary outcome was time from randomization to successful liberation from all forms of mechanical ventilation among survivors, measured in days, with the minimal clinically important difference defined as 1 day. Secondary outcomes were duration of invasive and total ventilation (days), reintubation or tracheostomy rates, and survival.

主要预后终点为存活患者从随机分组至成功脱离所有类型机械通气的天数,临床重要的最小差异定义为1天。次要预后指标包括有创机械通气及总机械通气时间(天),再次插管或气管切开比例,以及存活。

Results 结果

Among 364 randomized patients (mean age, 63.1 [SD, 14.8] years; 50.5% male), 319 were evaluable for the primary effectiveness outcome (41 died before liberation, 2 withdrew, and 2 were discharged with ongoing ventilation). The median time to liberation was 4.3 days in the noninvasive group vs 4.5 days in the invasive group (adjusted hazard ratio, 1.1; 95% CI, 0.89-1.40). Competing risk analysis accounting for deaths had a similar result (adjusted hazard ratio, 1.1; 95% CI, 0.86-1.34). The noninvasive group received less invasive ventilation (median, 1 day vs 4 days; incidence rate ratio, 0.6; 95% CI, 0.47-0.87) and fewer total ventilator days (median, 3 days vs 4 days; incidence rate ratio, 0.8; 95% CI, 0.62-1.0). There was no significant difference in reintubation, tracheostomy rates, or survival. Adverse events occurred in 45 patients (24.7%) in the noninvasive group compared with 47 (25.8%) in the invasive group.

在总共 364 名接受随机分组的患者(平均年龄,63.1 [SD, 14.8] 岁;50.5% 为男性)中,319 名患者可评估主要疗效指标(41 名患者脱机前死亡,2名患者撤除治疗,2名患者出院时仍接受机械通气)。无创组至脱机的中位时间为4.3天,有创组为4.5天(校正后风险比,1.1;95% CI,0.89-1.40)。针对死亡的竞争性风险分析得到相似结果(校正后风险比,1.1;95% CI,0.86-1.34)。无创组有创通气时间更短(中位时间,1 天 vs 4 天;发生率比值,0.6;95% CI, 0.47-0.87),机械通气总天数较短(中位时间,3 天 vs 4 天;发生率比值,0.8; 95% CI, 0.62-1.0)。两组间再次插管、气管切开或生存率无显著差异。无创组45名(24.7%)患者以及有创组47名(25.8%)患者发生不良事件。

Conclusions and Relevance 结论与意义

Among patients requiring mechanical ventilation in whom a spontaneous breathing trial had failed, early extubation to noninvasive ventilation did not shorten time to liberation from any ventilation.

对于接受机械通气且自主呼吸试验失败的患者,早期拔管过渡到无创通气不能缩短脱离机械通气时间。

Trial Registration

ISRCTN Identifier: ISRCTN15635197

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