Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Physiological Study of Minimally Invasive Extracorporeal CO2 Removal in Exacerbations of COPD Requiring Invasive Mechanical Ventilation
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.
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.
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