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自主呼吸试验后重新连接机械通气 1 小时对通气超过 12 小时的患者再次插管的影响:一项随机临床试验。

The Effect of Reconnection to Mechanical Ventilation for 1 Hour After Spontaneous Breathing Trial on Reintubation Among Patients Ventilated for More Than 12 Hours: A Randomized Clinical Trial.

机构信息

Universidade da Região de Joinville-UNIVILLE, Joinville, Brazil; Centro Hospitalar Unimed, Joinville, Brazil; Hospital Municipal São José, Joinville, Brazil.

Universidade da Região de Joinville-UNIVILLE, Joinville, Brazil; Centro Hospitalar Unimed, Joinville, Brazil.

出版信息

Chest. 2021 Jul;160(1):148-156. doi: 10.1016/j.chest.2021.02.064. Epub 2021 Mar 4.

Abstract

BACKGROUND

The resting of the respiratory musculature after undergoing the spontaneous breathing trial (SBT) to prevent extubation failures in critically ill patients needs to be studied further.

RESEARCH QUESTION

Is the reconnection to mechanical ventilation (MV) for 1 h after a successful SBT able to reduce the risk of reintubation?

STUDY DESIGN AND METHODS

Randomized clinical trial conducted in four ICUs between August 2018 and July 2019. Candidates for tracheal extubation who met all screening criteria for weaning were included. After achieving success in the SBT using a T-tube, the patients were randomized to the following groups: direct extubation (DE) or extubation after reconnection to MV for 1 h (R1h). The primary outcome was reintubation within 48 h.

RESULTS

Among the 336 patients studied (women, 41.1%; median age, 59 years [interquartile range, 45-70 years]), 12.9% (22/171) in the R1h group required reintubation within 48 h vs 18.2% (30/165) in the DE group (risk difference, 5.3 [95% CI, -2.49 to 13.12]; P = .18). No differences were found in mortality, length of ICU or hospital stay, causes of reintubation, or signs of extubation failure. A prespecified exploratory analysis showed that among the 233 patients (69.3%) who were ventilated for more than 72 h, the incidence of reintubation was 12.7% (15/118) in the R1h group compared with 22.6% (26/115) observed in the DE group (P = .04).

INTERPRETATION

Reconnection to MV after a successful SBT, compared with DE, did not result in a statistically significant reduction in the risk of reintubation in mechanically ventilated patients. Subgroup exploratory findings suggest that the strategy may benefit patients who were ventilated for more than 72 h, which should be confirmed in further studies.

TRIAL REGISTRY

Brazilian Clinical Trials Registry; No.: RBR-3x8nxn; URL: www.ensaiosclinicos.gov.br.

摘要

背景

为了防止重症患者在接受自主呼吸试验(SBT)后发生拔管失败,需要进一步研究呼吸肌休息的问题。

研究问题

在 SBT 成功后重新连接机械通气(MV)1 小时是否能够降低再插管的风险?

研究设计和方法

这是一项在 2018 年 8 月至 2019 年 7 月期间在四个 ICU 进行的随机临床试验。所有符合脱机筛查标准的气管插管候选者均被纳入研究。在使用 T 管成功完成 SBT 后,患者被随机分配到直接拔管(DE)或重新连接 MV 1 小时后拔管(R1h)组。主要结局是 48 小时内再插管。

结果

在纳入的 336 例患者中(女性占 41.1%;中位年龄为 59 岁[四分位间距,45-70 岁]),R1h 组有 12.9%(22/171)患者在 48 小时内需要再插管,而 DE 组为 18.2%(30/165)(风险差异,5.3[95%CI,-2.49 至 13.12];P=.18)。两组间死亡率、ICU 或住院时间、再插管原因或拔管失败迹象均无差异。一项预设的探索性分析显示,在 233 例(69.3%)通气时间超过 72 小时的患者中,R1h 组的再插管发生率为 12.7%(15/118),而 DE 组为 22.6%(26/115)(P=.04)。

解释

与直接拔管相比,SBT 成功后重新连接 MV 并不能显著降低机械通气患者再插管的风险。亚组探索性分析结果表明,该策略可能对通气时间超过 72 小时的患者有益,这需要在进一步的研究中加以证实。

试验注册

巴西临床试验注册处;编号:RBR-3x8nxn;网址:www.ensaiosclinicos.gov.br。

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