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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
ECCO2R in severe exacerbation of COPD patients, requiring invasive mechanical ventilation with persistent respiratory acidosis and dynamic hyperinflation
CHU d'Angers
Angers, France
Hopital de Bicetre, Hopitaux universitaires Paris Sud
Le Kremlin-Bicêtre, France
Hopital Europeen Georges Pompidou
Paris, France
intrinsic PEEP (PEEPi)
PEEPi at baseline and after ECCO2R by the Hemolung® device and adjustment of ventilator settings, expressed in cmH20
Time frame: 12 hours (between measurements at baseline and under ECCO2R)
Functional Residual capacity (FRC)
FRC using the nitrogen washout method, expressed in mL
Time frame: 12 hours (between measurements at baseline and under ECCO2R)
PaO2
PaO2 expressed in mmHg
Time frame: 12 hours (between measurements at baseline and under ECCO2R)
PaCO2
PaCO2 expressed in mmHg
Time frame: 12 hours (between measurements at baseline and under ECCO2R)
Arterial O2 saturation
Arterial O2 saturation expressed in %
Time frame: 12 hours (between measurements at baseline and under ECCO2R)
pH
pH expressed in absolute value
Time frame: 12 hours (between measurements at baseline and under ECCO2R)
amount of sedative drugs
amount of sedative drugs (per day and cumulative)
Time frame: Average time period of 6 days
length of intubation
length of intubation (days)
Time frame: Average time period of 7 days, up to 28 days
length of ICU-stay
length of ICU-stay (days)
Time frame: Average time period of 8 days, up to 28 days
length of hospital stay
length of hospital stay (days)
Time frame: Average time period of 9 days, up to 28 days
ICU mortality
Number of in ICU-deceased participants (expressed in absolute number and %)
Time frame: Average time period of 9 days, up to 28 days
catheter related complications
catheter related complications (thrombosis, bleeding, pneumothorax, infection) expressed in total number of complications, in average number of complications per participant and in number of patients with complications
Time frame: Average time period of 9 days
Hemolung related complications
Hemolung related complications (thrombosis, bleeding) expressed in total number of complications, in average number of complications per participant and in number of patients with complications
Time frame: Average time period of 9 days
non catheter-related bleedings
non catheter-related bleedings expressed in total number of bleedings, in average number of bleedings per participant and in number of patients with bleedings
Time frame: Average time period of 9 days
work of breathing per Liter
work of breathing with and without ECCO2R, expressed in Joules per Liter of ventilation
Time frame: Average time period of 7 days
work of breathing per minute
work of breathing with and without ECCO2R, expressed in Joules per minute
Time frame: Average time period of 7 days
work of breathing per breath
work of breathing with and without ECCO2R, expressed in Joules per breath
Time frame: Average time period of 7 days
Occlusion pressure in 100msec (P0.1)
Occlusion pressure in 100msec in parallel to work breathing measurements with and without ECCO2, expressed in cmH2O
Time frame: Average time period of 7 days
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