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临床试验/NCT04882410
NCT04882410已完成不适用

Extracorporeal CO2 Removal in Acute Exacerbation of COPD Not Responding to Non-Invasive Ventilation: a Single Center Experience

Centre Hospitalier de Saint-Denis0 个研究点目标入组 56 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
56
主要终点
Need for invasive mechanical ventilation despite ECCO2R technique

研究概览

简要总结

Background: Acute exacerbation of chronic obstructive pulmonary disease (ae-COPD) has a gold standard treatment: non-invasive ventilation (NIV). However, this treatment sometime fails, and an invasive mechanical ventilation (IMV) is required. The extracorporeal CO₂ removal (ECCO₂R) device can be an alternative to intubation. The aim of the study is to evaluate ECCO₂R efficiency and safety and enlighten ECCO₂R benefit/risk compared to IMV.

Methods: Successive ae-COPD patients for whom NIV failed were retrospectively analyzed during two periods: before and after the ECCO₂R device implementation in our ICU in 2015. We considered the before period as standard of care and patients were treated with IMV. The ECCO₂R device was a pump-driven veno-venous system (Xenios AG).

详细描述

The study compare 2 strategies for COPD patients not responding to non invasive ventilation: the gold standard which is mechanical ventilation and a new technique which is extracorporeal CO2 removal. This technique have been implemented in februrary 2015 in our intensive care unit so we choose to compare patients' outcome before and after the arriving of this device.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age > 18 years old
  • no improvement or worsening of respiratory acidosis after more than one hour of non invasive ventilation treatment
  • and non improvement of respiratory distress signs
  • and pH < 7,35 and PaCO2 > 45 mmHg

排除标准

  • patients not eligible for endotracheal intubation because of ethical limitations

结局指标

主要结局

Need for invasive mechanical ventilation despite ECCO2R technique

时间窗: From the begining of the ECCO2R treatment until the end of the ICU hospitalization, up to 6months

Rate of patients who needed invasive mechanical ventilation despite ECCO2R technique

次要结局

  • ECCO2R efficiency(During the treatment up to 6months)
  • Adverse Effects related to ECCO2R and invasive mechanical ventilation during the ICU hospitalization(During the ICU hospitalization up to 6months)
  • Mortality at day 28 and day 90(From the entrance in ICU until day 90)
  • ICU and hospital length of stay(From the entrance in ICU until the end of hospitalization in ICU and hospital up to 6months)

研究者

发起方
Centre Hospitalier de Saint-Denis
申办方类型
Other
责任方
Principal Investigator
主要研究者

SILVA

Principal Investigator

Centre Hospitalier de Saint-Denis

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