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体外二氧化碳去除术避免 COPD 患者因急性高碳酸血症呼吸衰竭对无创通气无反应而插管的可行性和安全性(ECLAIR 研究):多中心病例对照研究。

The feasibility and safety of extracorporeal carbon dioxide removal to avoid intubation in patients with COPD unresponsive to noninvasive ventilation for acute hypercapnic respiratory failure (ECLAIR study): multicentre case-control study.

机构信息

Department of Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Germany.

Department of Intensive Care Medicine, Hospital Barmherzige Brueder, Munich, Germany.

出版信息

Intensive Care Med. 2016 Sep;42(9):1437-44. doi: 10.1007/s00134-016-4452-y. Epub 2016 Jul 25.

DOI:10.1007/s00134-016-4452-y
PMID:27456703
Abstract

INTRODUCTION

The aim of the study was to evaluate the feasibility and safety of avoiding invasive mechanical ventilation (IMV) by using extracorporeal CO2 removal (ECCO2R) in patients with acute exacerbation of chronic obstructive pulmonary disease (COPD) and acute hypercapnic respiratory failure refractory to noninvasive ventilation (NIV).

METHODS

Case-control study. Patients with acute hypercapnic respiratory failure refractory to NIV being treated with a pump-driven veno-venous ECCO2R system (iLA-Activve(®); Novalung, Heilbronn, Germany) were prospectively observed in five European intensive care units (ICU). Inclusion criteria were respiratory acidosis (pH ≤ 7.35, PaCO2 > 45 mmHg) with predefined criteria for endotracheal intubation (ClinicalTrials.gov NCT01784367). The historical controls were patients with acute hypercapnic respiratory failure refractory to NIV who were treated with IMV. The matching criteria were main diagnosis, age, SAPS-II score and pH.

RESULTS

Twenty-five cases (48.0 % male, mean age 67.3 years) were matched with 25 controls. Intubation was avoided in 14 patients (56.0 %) in the ECCO2R group with a mean extracorporeal blood flow of 1.3 L/min. Seven patients were intubated because of progressive hypoxaemia and four owing to ventilatory failure despite ECCO2R and NIV. Relevant ECCO2R-associated adverse events were observed in 11 patients (44.0 %), of whom 9 (36.0 %) suffered major bleeding complications. The mean time on IMV, ICU stay and hospital stay in the case and control groups were 8.3 vs. 13.7, 28.9 vs. 24.0 and 36.9 vs. 37.0 days, respectively, and the 90-day mortality rates were 28.0 vs. 28.0 %.

CONCLUSIONS

The use of veno-venous ECCO2R to avoid invasive mechanical ventilation was successful in just over half of the cases. However, relevant ECCO2R-associated complications occurred in over one-third of cases. Despite the shorter period of IMV in the ECCO2R group there were no significant differences in length of stay or in 28- and 90-day mortality rates between the two groups. Larger, randomised studies are warranted for further assessment of the effectiveness of ECCO2R.

摘要

简介

本研究旨在评估体外 CO2 去除(ECCO2R)在对无创通气(NIV)无反应的慢性阻塞性肺疾病(COPD)急性加重和急性高碳酸血症性呼吸衰竭患者中避免有创机械通气(IMV)的可行性和安全性。

方法

病例对照研究。在欧洲的五个重症监护病房(ICU)中,前瞻性观察了 25 例使用泵驱动的静脉-静脉 ECCO2R 系统(iLA-Activve®;Novalung,德国海利布隆)治疗的急性高碳酸血症性呼吸衰竭对 NIV 无反应的患者。纳入标准为呼吸性酸中毒(pH 值≤7.35,PaCO2>45mmHg),并根据预设标准行气管插管(ClinicalTrials.gov NCT01784367)。历史对照为急性高碳酸血症性呼吸衰竭对 NIV 无反应并接受 IMV 治疗的患者。匹配标准为主要诊断、年龄、SAPS-II 评分和 pH 值。

结果

25 例患者(48.0%为男性,平均年龄 67.3 岁)与 25 例对照相匹配。在 ECCO2R 组中,有 14 例(56.0%)患者避免了插管,体外血液流量平均为 1.3L/min。由于进行性低氧血症,有 7 例患者需要插管,由于 ECCO2R 和 NIV 联合应用后仍存在通气失败,有 4 例患者需要插管。11 例(44.0%)患者出现与 ECCO2R 相关的不良事件,其中 9 例(36.0%)发生严重出血并发症。病例组和对照组的有创机械通气时间、ICU 住院时间和住院时间分别为 8.3 天 vs. 13.7 天、28.9 天 vs. 24.0 天和 36.9 天 vs. 37.0 天,90 天死亡率分别为 28.0% vs. 28.0%。

结论

静脉-静脉 ECCO2R 用于避免有创机械通气的成功率略高于一半。然而,三分之一以上的病例出现了与 ECCO2R 相关的并发症。尽管 ECCO2R 组的有创机械通气时间较短,但两组间 ICU 住院时间、住院时间和 28 天及 90 天死亡率均无显著差异。需要更大规模的随机研究来进一步评估 ECCO2R 的有效性。

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