Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04882410
Recruitment Status : Completed
First Posted : May 12, 2021
Last Update Posted : May 12, 2021
Sponsor:
Information provided by (Responsible Party):
SILVA, 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).


Condition or disease
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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 56 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Extracorporeal CO2 Removal in Acute Exacerbation of COPD Not Responding to Non-Invasive Ventilation: a Single Center Experience
Actual Study Start Date : January 2010
Actual Primary Completion Date : February 2020
Actual Study Completion Date : February 2020





Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: SILVA, Principal Investigator, Centre Hospitalier de Saint-Denis
ClinicalTrials.gov Identifier: NCT04882410    
Other Study ID Numbers: 0004_CohorteECCO2R
First Posted: May 12, 2021    Key Record Dates
Last Update Posted: May 12, 2021
Last Verified: May 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by SILVA, Centre Hospitalier de Saint-Denis:
Extracorporeal carbon-dioxide removal
ECCO2R
Acute Exacerbation
Chronic Obstructive Pulmonary Disease
Mechanical Ventilation