COPD Exacerbation AcuteNCT04882410
Extracorporeal CO2 Removal in Acute Exacerbation of COPD Not Responding to Non-Invasive Ventilation
An observational study of COPD Exacerbation Acute, run by Centre Hospitalier de Saint-Denis.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD Exacerbation Acute
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- patients not eligible for endotracheal intubation because of ethical limitations
About this study
Official title: 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).
Read the 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.
- Conditions
- COPD Exacerbation Acute
- Keywords
- Extracorporeal carbon-dioxide removal, ECCO2R, Acute Exacerbation, Chronic Obstructive Pulmonary Disease, Mechanical Ventilation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for invasive mechanical ventilation despite ECCO2R technique
Rate of patients who needed invasive mechanical ventilation despite ECCO2R technique
Measured: From the begining of the ECCO2R treatment until the end of the ICU hospitalization, up to 6months
Secondary outcomes (5)
ECCO2R efficiency
pH
Measured: During the treatment up to 6months
ECCO2R efficiency
PaCO2
Measured: 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
Measured: During the ICU hospitalization up to 6months
ICU and hospital length of stay
Length of stay in ICU and hospital
Measured: 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
Measured: From the entrance in ICU until day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study startJan 2010
- Primary completionFeb 2020
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPD Exacerbation AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Saint-Denis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SILVA, Centre Hospitalier de Saint-Denis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04882410
- Sponsor's protocol ID
- 0004_CohorteECCO2R
- Status last verified
- May 2021
- First submitted
- 2 Apr 2021
- Last updated
- 12 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 34893522
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal CO2 Removal in Acute Exacerbation of COPD Not Responding to Non-Invasive Ventilation: a Single Center Experience
- ClinicalTrials.gov ID
- NCT04882410
- Acronym / sponsor ID
- 0004_CohorteECCO2R
- Conditions
- COPD Exacerbation Acute
- Keywords
- Extracorporeal carbon-dioxide removal, ECCO2R, Acute Exacerbation, Chronic Obstructive Pulmonary Disease, Mechanical Ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Centre Hospitalier de Saint-DenisUniversity, hospital or other
- Study start
- Jan 2010 (actual)
- Primary completion
- Feb 2020 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 12 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- patients not eligible for endotracheal intubation because of ethical limitations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
ECCO2R efficiency
Time frame: During the treatment up to 6months
ECCO2R efficiency
Time frame: During the treatment up to 6months
Adverse Effects related to ECCO2R and invasive mechanical ventilation during the ICU hospitalization
Time frame: During the ICU hospitalization up to 6months
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
Mortality at day 28 and day 90
Time frame: From the entrance in ICU until day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2021.
- Derived from this study: PubMed 34893522Azzi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD Exacerbation Acute, run by Centre Hospitalier de Saint-Denis.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04882410, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2021.