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临床试验/NCT02586948
NCT02586948已完成不适用

Physiological Study of Minimally Invasive Extracorporeal CO2 Removal in Exacerbations of COPD Requiring Invasive Mechanical Ventilation

Assistance Publique - Hôpitaux de Paris3 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2016年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
3
主要终点
intrinsic PEEP (PEEPi)

研究概览

简要总结

Morbidity and mortality in COPD result largely of acute exacerbations.The optimization of the respiratory management represents a fundamental challenge for improving prognosis and reducing mortality. While the hospital mortality of patients treated with NIV has decreased over years, and is currently less than 10 %, mortality in patients treated with invasive ventilation remains higher than 25%. To improve the prognosis of patients with acute exacerbation of COPD requiring invasive mechanical ventilation is therefore a major challenge in terms of morbidity and mortality. Among the means available to achieve this goal, minimally invasive extracorporeal CO2 removal (ECCO2R) seems to be a very promising approach.

The investigators hypothesize that the addition of minimally invasive ECCO2R is likely to limit dynamic hyperinflation in COPD patients requiring invasive mechanical ventilation for an acute exacerbation, while improving gas exchange.

详细描述

Chronic obstructive pulmonary disease (COPD) is currently the fourth leading cause of death in the U.S. and is expected to become the third leading cause of death in 2020. Morbidity and mortality in COPD result largely of acute exacerbations, which are responsible for 1.5 million ED visits and 750,000 hospitalizations per year in the U.S. The optimization of the respiratory management of acute exacerbations represents a fundamental challenge for improving prognosis and reducing mortality. The value of non-invasive ventilation (NIV) for severe acute exacerbations of COPD was formally demonstrated by randomized clinical trials. In the setting of severe COPD exacerbations, NIV is actually very largely employed, largely ahead from invasive mechanical ventilation. While the hospital mortality of patients treated with NIV has decreased over years, and is currently less than 10 %, mortality in patients treated with invasive ventilation remains as high than 25%. Mortality in patients treated with invasive ventilation after failure of NIV seems to be growing and is actually close to 30%. To improve the prognosis of patients with acute exacerbation of COPD requiring invasive mechanical ventilation is therefore a major challenge in terms of morbidity and mortality. Among the means available to achieve this goal, minimally invasive extracorporeal CO2 removal (ECCO2R) seems to be a very promising approach.

The investigators hypothesize that the addition of minimally invasive ECCO2R is likely to limit dynamic hyperinflation in COPD patients requiring invasive ventilation for an acute exacerbation, while improving gas exchange. If confirmed, it could imply a more rapid weaning from invasive ventilation in relation to:

  • less hemodynamic consequences of positive pressure ventilation
  • reduced risk of baro-volo trauma of the lung parenchyma
  • reduction in the use of sedative drugs
  • a chest configuration minimizing diaphragmatic flattening, therefore favoring the generation of higher trans-diaphragmatic pressures
  • a decrease in the work of breathing (WOB), in connection with the previous point and with a decrease in alveolar ventilation required for pulmonary CO2 elimination during the ECCO2R treatment All of these elements are clinically relevant, as a reduction in the duration of invasive ventilation is associated in the literature with a decrease in the incidence of pneumonia associated with mechanical ventilation, as well as with a decrease in the duration of ICU-stay.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • •clinical exacerbation of a known or suspected COPD
  • •intubation and invasive mechanical ventilation since less than 72 hrs.
  • •ACV or CV mode (VT 8 ml/kg, RR 12/min., PEEP : 0 cmH20)
  • •pH < 7.30 and PaCO2 > 55 mm Hg and PEEPi (end-expiratory occlusion) > 5 cmH20
  • •written inform consent (patient, patient's legal surrogate)
  • •affiliation to a social security regime

排除标准

  • •Body Mass Index (BMI) > 35 kg/m2
  • •PaO2/FiO2 < 200 mm Hg
  • •history of hemorrhagic stroke
  • •heparin-induced thrombocytopenia
  • •Severe thrombopenia type II history

研究组 & 干预措施

extracorporeal CO2 removal

Experimental

extracorporeal CO2 removal initiated shortly after intubation, using the veno-venous Hemolung device

干预措施: extracorporeal CO2 removal (Hemolung device) (Device)

结局指标

主要结局

intrinsic PEEP (PEEPi)

时间窗: 12 hours (between measurements at baseline and under ECCO2R)

PEEPi at baseline and after ECCO2R by the Hemolung® device and adjustment of ventilator settings, expressed in cmH20

次要结局

  • catheter related complications(Average time period of 9 days)
  • Arterial O2 saturation(12 hours (between measurements at baseline and under ECCO2R))
  • pH(12 hours (between measurements at baseline and under ECCO2R))
  • amount of sedative drugs(Average time period of 6 days)
  • work of breathing per Liter(Average time period of 7 days)
  • Functional Residual capacity (FRC)(12 hours (between measurements at baseline and under ECCO2R))
  • PaO2(12 hours (between measurements at baseline and under ECCO2R))
  • length of intubation(Average time period of 7 days, up to 28 days)
  • length of ICU-stay(Average time period of 8 days, up to 28 days)
  • ICU mortality(Average time period of 9 days, up to 28 days)
  • Hemolung related complications(Average time period of 9 days)
  • length of hospital stay(Average time period of 9 days, up to 28 days)
  • PaCO2(12 hours (between measurements at baseline and under ECCO2R))
  • non catheter-related bleedings(Average time period of 9 days)
  • work of breathing per breath(Average time period of 7 days)
  • Occlusion pressure in 100msec (P0.1)(Average time period of 7 days)
  • work of breathing per minute(Average time period of 7 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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