Extracorporeal CO2 Removal in Acute Exacerbation of COPD Not Responding to Non-Invasive Ventilation
- Conditions
- COPD Exacerbation Acute
- Registration Number
- NCT04882410
- Lead Sponsor
- Centre Hospitalier de Saint-Denis
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
- 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
- patients not eligible for endotracheal intubation because of ethical limitations
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Need for invasive mechanical ventilation despite ECCO2R technique From the begining of the ECCO2R treatment until the end of the ICU hospitalization, up to 6months Rate of patients who needed invasive mechanical ventilation despite ECCO2R technique
- Secondary Outcome Measures
Name Time Method ECCO2R efficiency During the treatment up to 6months PaCO2
Adverse Effects related to ECCO2R and invasive mechanical ventilation during the ICU hospitalization During the ICU hospitalization up to 6months Rate of complications related to ECCO2R and invasive mechanical ventilation: hemorrhagic, thrombotic, haemodynamic, ventilator associated pneumonia, self extubation, death
Mortality at day 28 and day 90 From the entrance in ICU until day 90 Mortality at day 28 and day 90
ICU and hospital length of stay From the entrance in ICU until the end of hospitalization in ICU and hospital up to 6months Length of stay in ICU and hospital