JAMA:创伤患者的叹气通气:SIVENT随机临床试验

2023-10-31 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:2023-10-25

原文链接:https://jamanetwork.com/journals/jama/article-abstract/2811211

关键点内容如下:

问题

在接受机械通气的创伤患者的常规护理中增加叹气呼吸是否会增加无呼吸机天数?

调查结果

在524名具有急性呼吸窘迫综合征危险因素的创伤患者的随机临床试验中,与单独常规护理相比,增加叹气并未显著增加无呼吸机天数(无呼吸机天数中位数分别为18.4和16.1)。尽管没有对多重测试进行调整,但叹气呼吸与包括全因死亡率在内的次要结果的改善相关。没有证据表明有伤害。

意义

在接受机械通气的创伤患者中,在常规护理中增加叹气并不能显著增加无呼吸机天数,但可能会改善临床结果。

摘要内容如下:

重要性

在接受机械通气的患者中,每次呼吸的潮气量通常是恒定的或相似的。这可能通过改变或消耗表面活性物质而导致呼吸机诱导的肺损伤。在有预后不良风险的创伤患者中,叹气呼吸在减少呼吸机导致的肺损伤中的作用尚不清楚。

目的

确定增加叹气呼吸是否能改善临床结果。

研究设计和参与者

2016年至2022年,在美国15个学术创伤中心进行了一项关于叹气呼吸加常规护理的实用随机试验,随访时间为28天。纳入标准为年龄大于18岁,因创伤进行机械通气的时间少于24小时,发生急性呼吸窘迫综合征的5个危险因素中有1个或1个以上,预期通气持续时间超过24小时,预测生存时间超过48小时。

干预措施

每6分钟输送一次产生35 cm H2O(或对于体重指数>35的住院患者为40 cm H2O)的平台压力的叹息量。常规护理被定义为患者的医生按照他们的意愿治疗患者。

主要结局和措施

主要结果是无呼吸机天数。预先指定的次要转归包括全因28天死亡率。

结果

在筛选的5753名患者中,有524名入选(平均[SD]年龄:43.9[19.2]岁;男性394例(75.2%)。随机接受SIGHS的患者的中位无呼吸机天数为18.4(IQR,7.0-25.2),仅接受常规护理的患者的中位无呼吸机天数为16.1(IQR,1.1-24.4)(P=.08)。组间无呼吸机天数的未校正平均差异为1.9天(95%CI,0.1至3.6),预先指定的校正平均差异为1.4天(95%CI,-0.2至3.0)。对于预先指定的次要结果,随机分配到SIGHS的患者的28天死亡率为11.6%(30/259),而接受常规护理的患者的死亡率为17.6%(46/261)(P=.05)。有症状的患者(80/259[30.9%])与无症状的患者(80/261[30.7%])相比,未观察到非致命性不良事件的差异。

结论和相关性

在一项实用的随机试验中,接受机械通气的创伤患者具有发生急性呼吸窘迫综合征的危险因素,增加叹气并不能显著增加无呼吸机天数。预先指定的次要结果数据表明,SIGH具有良好的耐受性,并可能改善临床结果。

英文原文如下:

Key Points

Question  Does adding sigh breaths to the usual care of trauma patients receiving mechanical ventilation increase ventilator-free days?

Findings  In this randomized clinical trial among 524 trauma patients with risk factors for developing acute respiratory distress syndrome, the addition of sigh breaths did not significantly increase ventilator-free days compared with usual care alone (median ventilator-free days, 18.4 vs 16.1, respectively). Although not adjusted for multiple testing, sigh breaths were associated with improvement in secondary outcomes including all-cause mortality. There was no evidence of harm.

Meaning  Sigh breaths added to usual care did not significantly increase ventilator-free days among trauma patients who received mechanical ventilation but may improve clinical outcomes.

Abstract

Importance  Among patients receiving mechanical ventilation, tidal volumes with each breath are often constant or similar. This may lead to ventilator-induced lung injury by altering or depleting surfactant. The role of sigh breaths in reducing ventilator-induced lung injury among trauma patients at risk of poor outcomes is unknown.

Objective  To determine whether adding sigh breaths improves clinical outcomes.

Design, Setting, and Participants  A pragmatic, randomized trial of sigh breaths plus usual care conducted from 2016 to 2022 with 28-day follow-up in 15 academic trauma centers in the US. Inclusion criteria were age older than 18 years, mechanical ventilation because of trauma for less than 24 hours, 1 or more of 5 risk factors for developing acute respiratory distress syndrome, expected duration of ventilation longer than 24 hours, and predicted survival longer than 48 hours.

Interventions  Sigh volumes producing plateau pressures of 35 cm H2O (or 40 cm H2O for inpatients with body mass indexes >35) delivered once every 6 minutes. Usual care was defined as the patient’s physician(s) treating the patient as they wished.

Main Outcomes and Measures  The primary outcome was ventilator-free days. Prespecified secondary outcomes included all-cause 28-day mortality.

Results  Of 5753 patients screened, 524 were enrolled (mean [SD] age, 43.9 [19.2] years; 394 [75.2%] were male). The median ventilator-free days was 18.4 (IQR, 7.0-25.2) in patients randomized to sighs and 16.1 (IQR, 1.1-24.4) in those receiving usual care alone (P = .08). The unadjusted mean difference in ventilator-free days between groups was 1.9 days (95% CI, 0.1 to 3.6) and the prespecified adjusted mean difference was 1.4 days (95% CI, −0.2 to 3.0). For the prespecified secondary outcome, patients randomized to sighs had 28-day mortality of 11.6% (30/259) vs 17.6% (46/261) in those receiving usual care (P = .05). No differences were observed in nonfatal adverse events comparing patients with sighs (80/259 [30.9%]) vs those without (80/261 [30.7%]).

Conclusions and Relevance  In a pragmatic, randomized trial among trauma patients receiving mechanical ventilation with risk factors for developing acute respiratory distress syndrome, the addition of sigh breaths did not significantly increase ventilator-free days. Prespecified secondary outcome data suggest that sighs are well-tolerated and may improve clinical outcomes.

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