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Clinical Trials/NCT04882410
NCT04882410
Completed
Not Applicable

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

Centre Hospitalier de Saint-Denis0 sites56 target enrollmentJanuary 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COPD Exacerbation Acute
Sponsor
Centre Hospitalier de Saint-Denis
Enrollment
56
Primary Endpoint
Need for invasive mechanical ventilation despite ECCO2R technique
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2010
End Date
February 2020
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Centre Hospitalier de Saint-Denis
Responsible Party
Principal Investigator
Principal Investigator

SILVA

Principal Investigator

Centre Hospitalier de Saint-Denis

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

Outcomes

Primary Outcomes

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

  • ECCO2R efficiency(During the treatment up to 6months)
  • Adverse Effects related to ECCO2R and invasive mechanical ventilation during the ICU hospitalization(During the ICU hospitalization up to 6months)
  • Mortality at day 28 and day 90(From the entrance in ICU until 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)

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