Augy J L, Aissaoui N, Richard C, Maury E, Fartoukh M, Mekontso-Dessap A, Paulet R, Anguel N, Blayau C, Cohen Y, Chiche J D, Gaudry S, Voicu S, Demoule A, Combes A, Megarbane B, Charpentier E, Haghighat S, Panczer M, Diehl J L
1Service de Médecine Intensive Réanimation, AP-HP, Hôpital Européen Georges Pompidou, Paris, France.
2Service de Médecine Intensive Réanimation, AP-HP, Hôpital de Bicètre, Le Kremlin Bicètre, France.
J Intensive Care. 2019 Aug 20;7:45. doi: 10.1186/s40560-019-0399-8. eCollection 2019.
Extracorporeal carbon dioxide removal (ECCOR) is a promising technique for the management of acute respiratory failure, but with a limited level of evidence to support its use outside clinical trials and/or data collection initiatives. We report a collaborative initiative in a large metropolis.
To assess on a structural basis the rate of utilization as well as efficacy and safety parameters of 2 ECCOR devices in 10 intensive care units (ICU) during a 2-year period.
Seventy patients were recruited in 10 voluntary and specifically trained centers. The median utilization rate was 0.19 patient/month/center (min 0.04; max 1.20). ECCOR was started under invasive mechanical ventilation (IMV) in 59 patients and non-invasive ventilation in 11 patients. The Hemolung Respiratory Assist System (Alung) was used in 53 patients and the iLA Activve iLA kit (Xenios Novalung) in 17 patients. Main indications were ultraprotective ventilation for ARDS patients ( = 24), shortening the duration of IMV in COPD patients ( = 21), preventing intubation in COPD patients ( = 9), and controlling hypercapnia and dynamic hyperinflation in mechanically ventilated patients with severe acute asthma ( = 6). A reduction in median was observed in ARDS patients from 5.9 to 4.1 ml/kg ( <0.001). A reduction in PaCO values was observed in AE-COPD patients from 67.5 to 51 mmHg (< 0.001). Median duration of ECCOR was 5 days (IQR 3-8). Reasons for ECCOR discontinuation were improvement ( = 33), ECCOR-related complications ( = 18), limitation of life-sustaining therapies or measures decision ( = 10), and death ( = 9). Main adverse events were hemolysis ( = 21), bleeding ( = 17), and lung membrane clotting ( = 11), with different profiles between the devices. Thirty-five deaths occurred during the ICU stay, 3 of which being ECCOR-related.
Based on a registry, we report a low rate of ECCOR device utilization, mainly in severe COPD and ARDS patients. Physiological efficacy was confirmed in these two populations. We confirmed safety concerns such as hemolysis, bleeding, and thrombosis, with different profiles between the devices. Such results could help to design future studies aiming to enhance safety, to demonstrate a still-lacking strong clinical benefit of ECCOR, and to guide the choice between different devices.
ClinicalTrials.gov: Identifier: NCT02965079 retrospectively registered https://clinicaltrials.gov/ct2/show/NCT02965079.
体外二氧化碳清除（ECCOR）是治疗急性呼吸衰竭的一项有前景的技术，但支持其在临床试验和/或数据收集项目之外使用的证据有限。我们报告了在一个大都市开展的一项合作项目。
在两年时间里，对10个重症监护病房（ICU）中2种ECCOR设备的使用频率以及疗效和安全性参数进行结构性评估。
在10个自愿参与且经过专门培训的中心招募了70例患者。中位使用率为0.19例患者/月/中心（最小值0.04；最大值1.20）。59例患者在有创机械通气（IMV）时开始使用ECCOR，11例患者在无创通气时开始使用。53例患者使用了Hemolung呼吸辅助系统（Alung），17例患者使用了iLA Activve iLA套件（Xenios Novalung）。主要适应证为对急性呼吸窘迫综合征（ARDS）患者进行超保护性通气（n = 24）、缩短慢性阻塞性肺疾病（COPD）患者的IMV持续时间（n = 21）、预防COPD患者插管（n = 9）以及控制重度急性哮喘机械通气患者的高碳酸血症和动态肺过度充气（n = 6）。观察到ARDS患者的中位平台压从5.9降至4.1 ml/kg（P < 0.001）。AE-COPD患者的动脉血二氧化碳分压（PaCO）值从67.5降至51 mmHg（P < 0.001）。ECCOR的中位持续时间为5天（四分位间距3 - 8天）。停止使用ECCOR的原因包括病情改善（n = 33）、ECCOR相关并发症（n = 18）、维持生命治疗或措施受限或决定（n = 10）以及死亡（n = 9）。主要不良事件为溶血（n = 21）、出血（n = 17）和肺膜凝血（n = 11），不同设备的不良事件情况有所不同。在ICU住院期间发生了35例死亡，其中3例与ECCOR相关。
基于一项注册研究，我们报告ECCOR设备的使用率较低，主要用于重度COPD和ARDS患者。在这两类人群中证实了其生理疗效。我们确认了溶血、出血和血栓形成等安全问题，不同设备的情况有所不同。这些结果有助于设计未来的研究，旨在提高安全性、证明ECCOR仍缺乏的显著临床益处，并指导不同设备之间的选择。
ClinicalTrials.gov：标识符：NCT02965079，回顾性注册https://clinicaltrials.gov/ct2/show/NCT02965079 。
