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

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

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).

Study Overview

• Status: Completed
• Conditions: COPD Exacerbation Acute

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.

• Study Type: Observational
• Enrollment (Actual): 56

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier de Saint-Denis

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): February 1, 2020
• Study Completion (Actual): February 1, 2020

Study Registration Dates

• First Submitted: April 2, 2021
• First Submitted That Met QC Criteria: May 8, 2021
• First Posted (Actual): May 12, 2021

Study Record Updates

• Last Update Posted (Actual): May 12, 2021
• Last Update Submitted That Met QC Criteria: May 8, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Mechanical Ventilation; Chronic Obstructive Pulmonary Disease; ECCO2R; Acute Exacerbation; Extracorporeal carbon-dioxide removal
• Other Study ID Numbers: 0004_CohorteECCO2R

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No