急性低氧性呼吸衰竭和 ARDS 患者叹气：PROTECTION 试验的初步随机临床试验。

Sigh in Patients With Acute Hypoxemic Respiratory Failure and ARDS: The PROTECTION Pilot Randomized Clinical Trial.

机构信息

Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy; Department of Anesthesia, Critical Care and Emergency, Foundation IRCCS Cà Granda Maggiore Policlinico Hospital, Milan, Italy.

Anesthesia and Critical Care, San Gerardo Hospital, ASST Monza, Italy; School of Medicine and Surgery, University of Milan-Bicocca, Monza, Italy.

出版信息

Chest. 2021 Apr;159(4):1426-1436. doi: 10.1016/j.chest.2020.10.079. Epub 2020 Nov 13.

DOI:10.1016/j.chest.2020.10.079

PMID:33197403

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7664474/

Abstract

BACKGROUND

Sigh is a cyclic brief recruitment maneuver: previous physiologic studies showed that its use could be an interesting addition to pressure support ventilation to improve lung elastance, decrease regional heterogeneity, and increase release of surfactant.

RESEARCH QUESTION

Is the clinical application of sigh during pressure support ventilation (PSV) feasible?

STUDY DESIGN AND METHODS

We conducted a multicenter noninferiority randomized clinical trial on adult intubated patients with acute hypoxemic respiratory failure or ARDS undergoing PSV. Patients were randomized to the no-sigh group and treated by PSV alone, or to the sigh group, treated by PSV plus sigh (increase in airway pressure to 30 cm HO for 3 s once per minute) until day 28 or death or successful spontaneous breathing trial. The primary end point of the study was feasibility, assessed as noninferiority (5% tolerance) in the proportion of patients failing assisted ventilation. Secondary outcomes included safety, physiologic parameters in the first week from randomization, 28-day mortality, and ventilator-free days.

RESULTS

Two-hundred and fifty-eight patients (31% women; median age, 65 [54-75] years) were enrolled. In the sigh group, 23% of patients failed to remain on assisted ventilation vs 30% in the no-sigh group (absolute difference, -7%; 95% CI, -18% to 4%; P = .015 for noninferiority). Adverse events occurred in 12% vs 13% in the sigh vs no-sigh group (P = .852). Oxygenation was improved whereas tidal volume, respiratory rate, and corrected minute ventilation were lower over the first 7 days from randomization in the sigh vs no-sigh group. There was no significant difference in terms of mortality (16% vs 21%; P = .337) and ventilator-free days (22 [7-26] vs 22 [3-25] days; P = .300) for the sigh vs no-sigh group.

INTERPRETATION

Among hypoxemic intubated ICU patients, application of sigh was feasible and without increased risk.

TRIAL REGISTRY

ClinicalTrials.gov; No.: NCT03201263; URL: www.clinicaltrials.gov.

摘要

背景

叹息是一种周期性的短暂募集手法：之前的生理学研究表明，在压力支持通气（PSV）中使用叹息可能是一种有趣的补充方法，可以改善肺弹性，降低区域异质性，并增加表面活性剂的释放。

研究问题

在压力支持通气（PSV）中应用叹息是否可行？

研究设计和方法

我们在接受 PSV 治疗的急性低氧性呼吸衰竭或 ARDS 的成年插管患者中进行了一项多中心非劣效性随机临床试验。患者被随机分为无叹息组和仅接受 PSV 治疗组，或叹息组，接受 PSV 加叹息（气道压力增加至 30cmH2O 持续 3 秒，每分钟一次），直至第 28 天或死亡或成功自主呼吸试验。该研究的主要终点是可行性，通过辅助通气失败的患者比例评估（5%的耐受度）。次要结局包括安全性、随机化后第一周的生理参数、28 天死亡率和无呼吸机天数。

结果

共有 258 名患者（31%为女性；中位年龄 65[54-75]岁）入组。在叹息组中，有 23%的患者无法继续接受辅助通气，而无叹息组中这一比例为 30%（绝对差异为-7%；95%CI，-18%至 4%；P=0.015 表示非劣效性）。叹息组和无叹息组的不良事件发生率分别为 12%和 13%（P=0.852）。与无叹息组相比，在随机化后第 7 天，叹息组的氧合改善，潮气量、呼吸频率和校正分钟通气量降低。在死亡率（16%对 21%；P=0.337）和无呼吸机天数（22[7-26]对 22[3-25]天；P=0.300）方面，叹息组和无叹息组之间无显著差异。