JAMA:严重ARDS患者体外膜肺氧合期间俯卧位:PRONECMO随机临床试验

2023-12-04 来源:JAMA

本文由小咖机器人翻译整理

期刊来源:JAMA

文献发表时间:2023-12-01

原文链接:https://jamanetwork.com/journals/jama/article-abstract/2812529

关键点内容如下:

问题

俯卧位可改善严重急性呼吸窘迫综合征(ARDS)患者的预后,但在接受静脉-静脉体外膜肺氧合(VV-ECMO)治疗严重ARDS的患者中,卧姿是否优于仰卧位?

调查结果

该随机临床试验纳入了170例接受VV-ECMO的COVID-19患者,俯卧位ECMO组中有38例(44%)患者在第60天成功脱离ECMO,而仰卧位ECMO组中有37例(44%)患者成功脱离ECMO,差异无统计学意义(亚分布风险比为1.11)。

意义

在接受VV-ECMO的严重ARDS患者中,与仰卧位相比,俯卧位并不能缩短成功脱离ECMO的时间。

摘要内容如下:

重要性

俯卧位可能改善严重急性呼吸窘迫综合征(ARDS)患者的预后,但与仰卧位相比,俯卧位是否能改善ARDS患者接受静脉-静脉体外膜肺氧合(VV-ECMO)的临床预后尚不清楚。

目的

在VV-ECMO支持的严重ARDS患者中,测试俯卧位与仰卧位是否会缩短成功脱离ECMO的时间。

研究设计和参与者

2021年3月3日至2021年12月7日期间,在法国14个重症监护病房(ICU)接受VV-ECMO治疗不到48小时的严重ARDS患者的随机临床试验。

干预措施

患者按1:1的比例随机分为俯卧位(至少4个疗程,每个疗程16小时)(n=86)和仰卧位(n=84)。

主要结局

是在随机分组后60天内成功脱离ECMO的时间。次要转归包括ECMO和无机械通气天数、ICU和住院时间、皮肤压力损伤、严重不良事件和90天随访时的全因死亡率。

结果

在170名(中位年龄的随机患者中,51名[IQR,43-59]岁;n=60名女性[35%]),呼吸系统顺应性中位数为15.0(IQR,10.7-20.6)ml/cm H2O;159名患者(94%)患有COVID-19相关ARDS;164例(96%)在ECMO启动前处于卧姿。在入组的60天内,俯卧位ECMO组86名患者中的38名(44%)成功脱离ECMO,而仰卧位ECMO组84名患者中的37名(44%)(风险差异,0.1%[95%CI,-14.9%至15.2%];亚分布风险比,1.11[95%CI,0.71-1.75];P=.64)。在90天内,ECMO持续时间(28天与32天无显著差异;差异,−4.9[95%CI,−11.2至1.5]天;P=.13)、ICU住院时间或90天死亡率(51%vs 48%;风险差异,2.4%[95%CI,-13.9%至18.6%];P=.62)。卧姿过程中未报告严重不良事件。

结论和相关性

在VV-ECMO支持的重度ARDS患者中,俯卧位与仰卧位相比,并未显著缩短成功脱离ECMO的时间。

英文原文如下:

Key Points

Question  Prone positioning may improve the outcome of patients with severe acute respiratory distress syndrome (ARDS), but is prone position superior to supine position among patients receiving venovenous extracorporeal membrane oxygenation (VV-ECMO) for severe ARDS?

Findings  In this randomized clinical trial that included 170 patients primarily with COVID-19 who were undergoing VV-ECMO, successful ECMO weaning at day 60 occurred in 38 patients (44%) in the prone ECMO group compared with 37 patients (44%) in the supine ECMO group, a nonsignificant difference (subdistribution hazard ratio, 1.11).

Meaning  Among patients with severe ARDS undergoing VV-ECMO, prone positioning did not reduce time to successful ECMO weaning compared with supine position.

Abstracts

Importance  Prone positioning may improve outcomes in patients with severe acute respiratory distress syndrome (ARDS), but it is unknown whether prone positioning improves clinical outcomes among patients with ARDS who are undergoing venovenous extracorporeal membrane oxygenation (VV-ECMO) compared with supine positioning.

Objective  To test whether prone positioning vs supine positioning decreases the time to successful ECMO weaning in patients with severe ARDS supported by VV-ECMO.

Design, Setting, and Participants  Randomized clinical trial of patients with severe ARDS undergoing VV-ECMO for less than 48 hours at 14 intensive care units (ICUs) in France between March 3, 2021, and December 7, 2021.

Interventions  Patients were randomized 1:1 to prone positioning (at least 4 sessions of 16 hours) (n = 86) or to supine positioning (n = 84).

Main Outcomes and Measures  The primary outcome was time to successful ECMO weaning within 60 days following randomization. Secondary outcomes included ECMO and mechanical ventilation–free days, ICU and hospital length of stay, skin pressure injury, serious adverse events, and all-cause mortality at 90-day follow-up.

Results  Among 170 randomized patients (median age, 51 [IQR, 43-59] years; n = 60 women [35%]), median respiratory system compliance was 15.0 (IQR, 10.7-20.6) mL/cm H2O; 159 patients (94%) had COVID-19–related ARDS; and 164 (96%) were in prone position before ECMO initiation. Within 60 days of enrollment, 38 of 86 patients (44%) had successful ECMO weaning in the prone ECMO group compared with 37 of 84 (44%) in the supine ECMO group (risk difference, 0.1% [95% CI, −14.9% to 15.2%]; subdistribution hazard ratio, 1.11 [95% CI, 0.71-1.75]; P = .64). Within 90 days, no significant difference was observed in ECMO duration (28 vs 32 days; difference, −4.9 [95% CI, −11.2 to 1.5] days; P = .13), ICU length of stay, or 90-day mortality (51% vs 48%; risk difference, 2.4% [95% CI, −13.9% to 18.6%]; P = .62). No serious adverse events were reported during the prone position procedure.

Conclusions and Relevance  Among patients with severe ARDS supported by VV-ECMO, prone positioning compared with supine positioning did not significantly reduce time to successful weaning of ECMO.

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