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| Name | Class |
|---|---|
| Alung Technologies | INDUSTRY |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| extracorporeal CO2 removal | Experimental | extracorporeal CO2 removal initiated shortly after intubation, using the veno-venous Hemolung device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| extracorporeal CO2 removal (Hemolung device) | Device | ECCO2R in severe exacerbation of COPD patients, requiring invasive mechanical ventilation with persistent respiratory acidosis and dynamic hyperinflation |
| Measure | Description | Time Frame |
|---|---|---|
| intrinsic PEEP (PEEPi) | PEEPi at baseline and after ECCO2R by the HemolungÂź device and adjustment of ventilator settings, expressed in cmH20 | 12 hours (between measurements at baseline and under ECCO2R) |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Residual capacity (FRC) | FRC using the nitrogen washout method, expressed in mL | 12 hours (between measurements at baseline and under ECCO2R) |
| PaO2 | PaO2 expressed in mmHg |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Luc Diehl | Assistance Publique - HĂŽpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU d'Angers | Angers | 49933 | France | |||
| Hopital de Bicetre, Hopitaux universitaires Paris Sud |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32990836 | Derived | Diehl JL, Piquilloud L, Vimpere D, Aissaoui N, Guerot E, Augy JL, Pierrot M, Hourton D, Arnoux A, Richard C, Mancebo J, Mercat A. Physiological effects of adding ECCO2R to invasive mechanical ventilation for COPD exacerbations. Ann Intensive Care. 2020 Sep 29;10(1):126. doi: 10.1186/s13613-020-00743-y. |
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|
| 12 hours (between measurements at baseline and under ECCO2R) |
| PaCO2 | PaCO2 expressed in mmHg | 12 hours (between measurements at baseline and under ECCO2R) |
| Arterial O2 saturation | Arterial O2 saturation expressed in % | 12 hours (between measurements at baseline and under ECCO2R) |
| pH | pH expressed in absolute value | 12 hours (between measurements at baseline and under ECCO2R) |
| amount of sedative drugs | amount of sedative drugs (per day and cumulative) | Average time period of 6 days |
| length of intubation | length of intubation (days) | Average time period of 7 days, up to 28 days |
| length of ICU-stay | length of ICU-stay (days) | Average time period of 8 days, up to 28 days |
| length of hospital stay | length of hospital stay (days) | Average time period of 9 days, up to 28 days |
| ICU mortality | Number of in ICU-deceased participants (expressed in absolute number and %) | 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 | 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 | 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 | 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 | Average time period of 7 days |
| work of breathing per minute | work of breathing with and without ECCO2R, expressed in Joules per minute | Average time period of 7 days |
| work of breathing per breath | work of breathing with and without ECCO2R, expressed in Joules per breath | 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 | Average time period of 7 days |
| Le Kremlin-BicĂȘtre |
| 94275 |
| France |
| Hopital Europeen Georges Pompidou | Paris | 75015 | France |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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