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

NCT ID: NCT04882410

Last Updated: 2021-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2020-02-29

Brief Summary

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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

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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

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COPD Exacerbation Acute

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier de Saint-Denis

OTHER

Sponsor Role lead

Responsible Party

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SILVA

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 34893522 (View on PubMed)

Other Identifiers

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0004_CohorteECCO2R

Identifier Type: -

Identifier Source: org_study_id

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