Extracorporeal CO2 Removal in Acute Exacerbation of COPD Not Responding to Non-Invasive Ventilation

Study Overview
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Brief Summary
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Background: Acute exacerbation of chronic obstructive pulmonary disease (ae-COPD) has a gold standard treatment: non-invasive ventilation (NIV). However, this treatment sometime fails, and an invasive mechanical ventilation (IMV) is required. The extracorporeal CO₂ removal (ECCO₂R) device can be an alternative to intubation. The aim of the study is to evaluate ECCO₂R efficiency and safety and enlighten ECCO₂R benefit/risk compared to IMV. Methods: Successive ae-COPD patients for whom NIV failed were retrospectively analyzed during two periods: before and after the ECCO₂R device implementation in our ICU in 2015. We considered the before period as standard of care and patients were treated with IMV. The ECCO₂R device was a pump-driven veno-venous system (Xenios AG).

Detailed Description
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The study compare 2 strategies for COPD patients not responding to non invasive ventilation: the gold standard which is mechanical ventilation and a new technique which is extracorporeal CO2 removal. This technique have been implemented in februrary 2015 in our intensive care unit so we choose to compare patients' outcome before and after the arriving of this device.

Official Title
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Extracorporeal CO2 Removal in Acute Exacerbation of COPD Not Responding to Non-Invasive Ventilation: a Single Center Experience

Conditions
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COPD Exacerbation Acute

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age > 18 years old no improvement or worsening of respiratory acidosis after more than one hour of non invasive ventilation treatment and non improvement of respiratory distress signs and pH < 7,35 and PaCO2 > 45 mmHg Exclusion Criteria: patients not eligible for endotracheal intubation because of ethical limitations

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for invasive mechanical ventilation despite ECCO2R technique | Rate of patients who needed invasive mechanical ventilation despite ECCO2R technique | From the begining of the ECCO2R treatment until the end of the ICU hospitalization, up to 6months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ECCO2R efficiency | pH | During the treatment up to 6months | 
| ECCO2R efficiency | PaCO2 | During the treatment up to 6months | 
| Adverse Effects related to ECCO2R and invasive mechanical ventilation during the ICU hospitalization | Rate of complications related to ECCO2R and invasive mechanical ventilation: hemorrhagic, thrombotic, haemodynamic, ventilator associated pneumonia, self extubation, death | During the ICU hospitalization up to 6months | 
| ICU and hospital length of stay | Length of stay in ICU and hospital | From the entrance in ICU until the end of hospitalization in ICU and hospital up to 6months | 
| Mortality at day 28 and day 90 | Mortality at day 28 and day 90 | From the entrance in ICU until day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ECCO2R, Extracorporeal carbon-dioxide removal, Acute Exacerbation, Chronic Obstructive Pulmonary Disease, Mechanical Ventilation