extracorporeal CO2 removal (Hemolung device)
DeviceECCO2R in severe exacerbation of COPD patients, requiring invasive mechanical ventilation with persistent respiratory acidosis and dynamic hyperinflation
Other names: ECCO2R
NCT Number: NCT02586948
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
CHU d'Angers, Angers, France
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ECCO2R in severe exacerbation of COPD patients, requiring invasive mechanical ventilation with persistent respiratory acidosis and dynamic hyperinflation
Other names: ECCO2R
Time frame: 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
Time frame: 12 hours (between measurements at baseline and under ECCO2R)
FRC using the nitrogen washout method, expressed in mL
Time frame: 12 hours (between measurements at baseline and under ECCO2R)
PaO2 expressed in mmHg
Time frame: 12 hours (between measurements at baseline and under ECCO2R)
PaCO2 expressed in mmHg
Time frame: 12 hours (between measurements at baseline and under ECCO2R)
Arterial O2 saturation expressed in %
Time frame: 12 hours (between measurements at baseline and under ECCO2R)
pH expressed in absolute value
Time frame: Average time period of 6 days
amount of sedative drugs (per day and cumulative)
Time frame: Average time period of 7 days, up to 28 days
length of intubation (days)
Time frame: Average time period of 8 days, up to 28 days
length of ICU-stay (days)
Time frame: Average time period of 9 days, up to 28 days
length of hospital stay (days)
Time frame: Average time period of 9 days, up to 28 days
Number of in ICU-deceased participants (expressed in absolute number and %)
Time frame: Average time period of 9 days
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 (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 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 7 days
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 with and without ECCO2R, expressed in Joules per minute
Time frame: Average time period of 7 days
work of breathing with and without ECCO2R, expressed in Joules per breath
Time frame: Average time period of 7 days
Occlusion pressure in 100msec in parallel to work breathing measurements with and without ECCO2, expressed in cmH2O
Assistance Publique - Hôpitaux de Paris
Other
Physiological Study of Minimally Invasive Extracorporeal CO2 Removal in Exacerbations of COPD Requiring Invasive Mechanical Ventilation
Acronym: EPHEBE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05984823
Chronic Disease, Chronic Obstructive Pulmonary Disease
Leicester, Leicestershire, United Kingdom
View Trial DetailsNCT05572333
COPD, Chronic Disease
Frankfurt, Germany
View Trial DetailsNCT03641235
Chronic Disease, Chronic Obstructive Pulmonary Disease
Bordeaux, France
View Trial DetailsNCT05984680
Chronic Disease, Chronic Obstructive Pulmonary Disease
Winston-Salem, North Carolina, United States
View Trial Details