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Early Extubation by ECCO2R Compared to IMV in Patients with Severe Acute Exacerbation of COPD

NCT03584295 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-03-14

No results posted yet for this study

Summary

The study aims to investigate if veno-venous (vv)-extracorporeal carbon dioxide Removal (ECCO2R) is capable of reducing mortality and/or severe disability at day 60 after randomisation in patients with severe acute exacerbation of chronic obstructive pulmonary disease (COPD) requiring invasive mechanical ventilation (IMV). Extubation will be facilitated by VV-ECCO2R and compared to IMV alone in a randomized controlled trial.

Conditions

  • COPD Exacerbation

Interventions

DEVICE

Extracorporeal carbon dioxide removal

Patients with acute exacerbation of severe COPD, requiring invasive mechanical ventilation will be treated with vv-ECCO2R to facilitate early extubation

OTHER

Conventional Care

Patient with acute exacerbation of severe COPD, requiring invasive mechanical ventilation treated with Conventional Care. Conventional care includes invasive mechanical ventilation and the attempt to extubate the patient and switch to NIV. If extubation fails tracheostomy can be performed according to the treating physician.

Sponsors & Collaborators

  • Winicker Norimed GmbH

    collaborator INDUSTRY

  • Xenios AG

    lead INDUSTRY

Principal Investigators

  • Christian Karagiannidis, Prof. Dr. · Kliniken der Stadt Köln gGmbH, ARDS and ECMO Zentrum Köln-Merheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-07
Primary Completion
2024-11-01
Completion
2024-11-25

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03584295 on ClinicalTrials.gov