Skip to main content
OpenTrials
Completed

NCT Number: NCT04882410

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

COPD Exacerbation Acute Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Need for invasive mechanical ventilation despite ECCO2R technique

    Time frame: 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 outcomes

  1. ECCO2R efficiency

    Time frame: During the treatment up to 6months

    pH

  2. ECCO2R efficiency

    Time frame: During the treatment up to 6months

    PaCO2

  3. Adverse Effects related to ECCO2R and invasive mechanical ventilation during the ICU hospitalization

    Time frame: 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

  4. ICU and hospital length of stay

    Time frame: From the entrance in ICU until the end of hospitalization in ICU and hospital up to 6months

    Length of stay in ICU and hospital

  5. Mortality at day 28 and day 90

    Time frame: From the entrance in ICU until day 90

    Mortality at day 28 and day 90

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Saint-Denis

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2020
Study completion
2020
First posted
May 12, 2021
Registry last updated
May 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.