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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04882410
Enrollment
56
Registered
2021-05-12
Start date
2010-01-31
Completion date
2020-02-29
Last updated
2021-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD Exacerbation Acute

Keywords

Extracorporeal carbon-dioxide removal, ECCO2R, Acute Exacerbation, Chronic Obstructive Pulmonary Disease, Mechanical Ventilation

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.

Interventions

None listed

Sponsors

Centre Hospitalier de Saint-Denis
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Need for invasive mechanical ventilation despite ECCO2R techniqueFrom the begining of the ECCO2R treatment until the end of the ICU hospitalization, up to 6monthsRate of patients who needed invasive mechanical ventilation despite ECCO2R technique

Secondary

MeasureTime frameDescription
ECCO2R efficiencyDuring the treatment up to 6monthspH
Adverse Effects related to ECCO2R and invasive mechanical ventilation during the ICU hospitalizationDuring the ICU hospitalization up to 6monthsRate of complications related to ECCO2R and invasive mechanical ventilation: hemorrhagic, thrombotic, haemodynamic, ventilator associated pneumonia, self extubation, death
ICU and hospital length of stayFrom the entrance in ICU until the end of hospitalization in ICU and hospital up to 6monthsLength of stay in ICU and hospital
Mortality at day 28 and day 90From the entrance in ICU until day 90Mortality at day 28 and day 90

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026