Department of Emergency and Critical Care Medicine, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.
Department of Emergency and Critical Care Medicine, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan
BMJ Open. 2023 Oct 18;13(10):e072680. doi: 10.1136/bmjopen-2023-072680.
While limiting the tidal volume to 6 mL/kg during veno-venous extracorporeal membrane oxygenation (V-V ECMO) to ameliorate lung injury in patients with acute respiratory distress syndrome (ARDS) is widely accepted, the best setting for positive end-expiratory pressure (PEEP) is still controversial. This study is being conducted to investigate whether a higher PEEP setting (15 cmHO) during V-V ECMO can decrease the duration of ECMO support needed in patients with severe ARDS, as compared with a lower PEEP setting.
The study is an investigator-initiated, multicentre, open-label, two-arm, randomised controlled trial conducted with the participation of 20 intensive care units (ICUs) at academic as well as non-academic hospitals in Japan. The subjects of the study are patients with severe ARDS who require V-V ECMO support. Eligible patients will be randomised equally to the high PEEP group or low PEEP group. Recruitment to the study will continue until a total of 210 patients with ARDS requiring V-V ECMO support have been randomised. In the high PEEP group, PEEP will be set at 15 cmHO from the start of V-V ECMO until the trials for liberation from V-V ECMO (or until day 28 after the allocation), while in the low PEEP group, the PEEP will be set at 5 cmHO. Other treatments will be the same in the two groups. The primary endpoint of the study is the number of ECMO-free days until day 28, defined as the length of time (in days) from successful libration from V-V ECMO to day 28. The secondary endpoints are mortality on day 28, in-hospital mortality on day 60, ventilator-free days during the first 60 days and length of ICU stay.
Ethics approval for the trial at all the participating hospitals was obtained on 27 September 2022, by central ethics approval (IRB at Hiroshima University Hospital, C2022-0006). The results of this study will be presented at domestic and international medical congresses, and also published in scientific journals.
The Japan Registry of Clinical Trials jRCT1062220062. Registered on 28 September 2022.
28 March 2023, version 4.0.
在进行静脉-静脉体外膜肺氧合（V-V ECMO）时，将潮气量限制在 6 毫升/公斤，以改善急性呼吸窘迫综合征（ARDS）患者的肺损伤，这一做法已被广泛接受，但最佳呼气末正压（PEEP）设置仍存在争议。本研究旨在探讨 V-V ECMO 期间较高的 PEEP 设置（15cmH2O）是否能比较低的 PEEP 设置（5cmH2O）缩短严重 ARDS 患者 ECMO 支持的持续时间。
本研究是一项由研究者发起的、多中心、开放标签、双臂、随机对照试验，在日本的 20 个学术和非学术医院的重症监护病房（ICU）参与下进行。研究对象为需要 V-V ECMO 支持的严重 ARDS 患者。符合条件的患者将被平均随机分配到高 PEEP 组或低 PEEP 组。研究将持续招募，直到共有 210 名需要 V-V ECMO 支持的 ARDS 患者被随机分组。在高 PEEP 组中，从开始 V-V ECMO 到 V-V ECMO 撤离试验（或分配后第 28 天），PEEP 将设置为 15cmH2O，而在低 PEEP 组中，PEEP 将设置为 5cmH2O。两组的其他治疗将相同。该研究的主要终点是第 28 天无 ECMO 天数，定义为从成功脱离 V-V ECMO 到第 28 天的时间长度（以天为单位）。次要终点是第 28 天死亡率、第 60 天院内死亡率、前 60 天无呼吸机天数和 ICU 住院时间。
所有参与医院的试验伦理批准于 2022 年 9 月 27 日通过中央伦理批准（广岛大学医院 IRB，C2022-0006）获得。该研究的结果将在国内和国际医学会议上展示，并发表在科学期刊上。
日本临床试验注册中心 jRCT1062220062。注册于 2022 年 9 月 28 日。
2023 年 3 月 28 日，第 4.0 版。
