Khemani Robinder G, Bhalla Anoopindar, Hotz Justin C, Klein Margaret J, Kwok Jeni, Kohler Kristen, Bornstein Dinnel, Chang Daniel, Armenta-Quiroz Anabel, Vu Kennedy, Smith Erin, Suresh Anil, Baron David, Bonilla-Cartagena Jennifer, Ross Patrick A, Deakers Timothy, Beltramo Fernando, Nelson Lara, Shah Shilpa, Elkunovich Marsha, Curley Martha A Q, Mack Wendy, Newth Christopher J L
Department of Anesthesiology and Critical Care Medicine, Children's Hospital Los Angeles, Los Angeles.
Keck School of Medicine, Department of Pediatrics, University of Southern California, Los Angeles.
NEJM Evid. 2025 Jun;4(6):EVIDoa2400360. doi: 10.1056/EVIDoa2400360. Epub 2025 May 27.
Mechanical ventilation strategies that balance lung and diaphragm protection have not been extensively tested in clinical trials.
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.
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 cmHO (95% CI, -5 to -2), positive end-expiratory pressure was -2 cmHO (95% CI, -2 to -1), and the esophageal pressure swing was -1.8 cmHO (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.
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.).
平衡肺和膈肌保护的机械通气策略尚未在临床试验中得到广泛测试。
我们在患有急性呼吸窘迫综合征的儿童中进行了一项单中心、II期随机对照试验，随机分组有两个时间点：通气的急性期和撤机期。干预组患者采用名为REDvent的计算机决策支持（CDS）工具和食管测压进行管理，以实现肺和膈肌保护性通气。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）。主要结局是撤机时间。
从2017年10月到2024年3月，248名儿童被随机分配到急性期。当参与者触发呼吸机时，吸气峰压的调整后平均差值（REDvent急性期 - 常规护理急性期）为-3 cmH₂O（95%CI，-5至-2），呼气末正压为-2 cmH₂O（95%CI，-2至-1），食管压力摆动为-1.8 cmH₂O（95%CI，-3.2至-0.3）。对于主要结局，55%的REDvent急性期患者通过了SBT或在首次SBT当天拔管，而常规护理急性期组为39%。在调整年龄、免疫抑制和氧合指数值后，REDvent急性期干预导致撤机时间比常规护理缩短的几率为1.67（95%CI，1.01至2.77；P = 0.045）。干预组从插管到通过SBT的中位时间为3.83天，而常规护理组为4.75天。幸存者的通气时间在干预组为5.0天，在常规护理组为5.6天。在比较撤机期随机分组时，两组的临床结局相似。两组之间不良事件无差异。
在通气急性期使用CDS工具的肺和膈肌保护性通气策略导致撤机时间比常规护理缩短。有必要对机械通气患者进行III期试验。（由美国国立卫生研究院等资助；ClinicalTrials.gov编号，NCT03266016。）
