Clinical trial NCT04882410: Extracorporeal CO2 Removal in Acute Exacerbation of COPD Not Responding to Non-Invasive Ventilation
Official title: Extracorporeal CO2 Removal in Acute Exacerbation of COPD Not Responding to Non-Invasive Ventilation: a Single Center Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD Exacerbation Acute
Keywords: Extracorporeal carbon-dioxide removal
ECCO2R
Acute Exacerbation
Chronic Obstructive Pulmonary Disease
Mechanical Ventilation
Lead sponsor: Centre Hospitalier de Saint-Denis
Sponsor class: OTHER
First posted: 2021-05-12
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Successive ae-COPD patients for whom non-invasive ventilation failed during two periods: before and after the ECCO2R device implementation in our ICU in 2015.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Need for invasive mechanical ventilation despite ECCO2R technique
timeFrame: From the begining of the ECCO2R treatment until the end of the ICU hospitalization, up to 6months
Secondary outcomes:
measure: ECCO2R efficiency
timeFrame: During the treatment up to 6months
measure: ECCO2R efficiency
timeFrame: During the treatment up to 6months
measure: Adverse Effects related to ECCO2R and invasive mechanical ventilation during the ICU hospitalization
timeFrame: During the ICU hospitalization up to 6months
measure: ICU and hospital length of stay
timeFrame: From the entrance in ICU until the end of hospitalization in ICU and hospital up to 6months
measure: Mortality at day 28 and day 90
timeFrame: From the entrance in ICU until day 90
Other outcomes:
Locations:
Study officials:
References:
citation: Azzi M, Aboab J, Alviset S, Ushmorova D, Ferreira L, Ioos V, Memain N, Issoufaly T, Lermuzeaux M, Laine L, Serbouti R, Silva D. Extracorporeal CO2 removal in acute exacerbation of COPD unresponsive to non-invasive ventilation. BMJ Open Respir Res. 2021 Dec;8(1):e001089. doi: 10.1136/bmjresp-2021-001089.