儿童肺膈保护通气的随机试验。

NEJM evidence Pub Date : 2025-06-01 Epub Date: 2025-05-27 DOI:10.1056/EVIDoa2400360
Robinder G Khemani, Anoopindar Bhalla, Justin C Hotz, Margaret J Klein, Jeni Kwok, Kristen Kohler, Dinnel Bornstein, Daniel Chang, Anabel Armenta-Quiroz, Kennedy Vu, Erin Smith, Anil Suresh, David Baron, Jennifer Bonilla-Cartagena, Patrick A Ross, Timothy Deakers, Fernando Beltramo, Lara Nelson, Shilpa Shah, Marsha Elkunovich, Martha A Q Curley, Wendy Mack, Christopher J L Newth
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引用次数: 0

摘要

背景:平衡肺和隔膜保护的机械通气策略尚未在临床试验中得到广泛测试。方法:对急性呼吸窘迫综合征患儿进行单中心II期随机对照试验,随机分配两个时间点:通气急性期和脱机期。干预组患者采用计算机决策支持(CDS)工具REDvent和食管测压术进行肺和膈保护通气。对照组接受常规护理。两组均进行每日标准化自主呼吸试验(SBT)。主要观察指标为断奶时间。结果:2017年10月至2024年3月,248名儿童随机分为急性期。当参与者触发呼吸机时,峰值吸气压的调整平均差值(REDvent-acute - usual care-acute)为-3 cmH2O (95% CI, -5至-2),呼气末正压为-2 cmH2O (95% CI, -2至-1),食管压力波动为-1.8 cmH2O (95% CI, -3.2至-0.3)。对于主要结果,55%的redvent急性患者通过了他们的SBT或在第一次SBT当天拔管,而常规护理急性组为39%。在调整了年龄、免疫抑制和氧合指数后,redvent急性干预导致1.67 (95% CI, 1.01 ~ 2.77;P=0.045)断奶时间比常规护理短的几率。干预组从插管到SBT通过的中位时间为3.83天,而常规护理组为4.75天。干预组幸存者的通气时间为5.0天,而常规护理组为5.6天。当比较断奶期随机分配时,两组临床结果相似。两组之间的不良事件没有差异。结论:在通气急性期使用CDS工具的肺和膈保护通气策略比常规护理可缩短脱机时间。在机械通气患者中进行III期试验是必要的。(由美国国立卫生研究院和其他机构资助;ClinicalTrials.gov号码:NCT03266016)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Randomized Trial of Lung and Diaphragm Protective Ventilation in Children.

Background: Mechanical ventilation strategies that balance lung and diaphragm protection have not been extensively tested in clinical trials.

Methods: We conducted a single-center, phase II randomized controlled trial in children with acute respiratory distress syndrome with two time points of random assignment: the acute and weaning phases of ventilation. Patients in the intervention group were managed with a computerized decision support (CDS) tool, named REDvent, and esophageal manometry to deliver lung and diaphragm protective ventilation. The control group received usual care. A daily standardized spontaneous breathing trial (SBT) was performed in both groups. The primary outcome was the length of weaning.

Results: From October 2017 through March 2024, 248 children were randomly assigned to the acute phase. When participants were triggering the ventilator, the adjusted mean difference (REDvent-acute - usual care-acute) for peak inspiratory pressure was -3 cmH2O (95% CI, -5 to -2), positive end-expiratory pressure was -2 cmH2O (95% CI, -2 to -1), and the esophageal pressure swing was -1.8 cmH2O (95% CI, -3.2 to -0.3). For the primary outcome, 55% of REDvent-acute patients passed their SBT or were extubated on the day of the first SBT, compared with 39% in the usual care-acute group. After adjusting for age, immunosuppression, and oxygenation index value, the REDvent-acute intervention resulted in a 1.67 (95% CI, 1.01 to 2.77; P=0.045) odds of a shorter length of weaning than usual care. The median time from intubation to SBT passage was 3.83 days in the intervention group versus 4.75 days in the usual care group. The length of ventilation among survivors was 5.0 days in the intervention group versus 5.6 days in the usual care group. When comparing weaning phase random assignment, clinical outcomes were similar between groups. There were no differences in adverse events between the groups.

Conclusions: A lung and diaphragm protective ventilation strategy using a CDS tool during the acute phase of ventilation resulted in a shorter length of weaning than usual care. Phase III trials in mechanically ventilated patients are warranted. (Funded by the National Institutes of Health and others; ClinicalTrials.gov number, NCT03266016.).

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