NCT03584295

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

A Multicentre, Randomized-controlled Trial of EXtracorporeal CO2 Removal to Facilitate Early Extubation Compared to Invasive Mechanical Ventilation in Patients with Severe Acute Exacerbation of COPD (X-COPD)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Xenios AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The current study hypothesizes an advantage for veno-venous extracorporeal carbon dioxide removal (VV-ECCO2R) in severe acute exacerbation of COPD requiring invasive mechanical ventilation (IMV) to facilitate early extubation in terms of reducing mortality or severe disability. The study hypothesizes that avoiding IMV could reduce mortality and substantially improve quality of life, especially in regard to avoidance of tracheostomy and long-term home IMV. Improvement in mobility due to sooner recovery has a further major impact on patients' QoL. After randomization patients with acute exacerbation of severe COPD, requiring invasive mechanical ventilation will be treated either with conventional care or VV-ECCO2R to facilitate early extubation. VV-ECCO2R is used in a standard configuration with either double lumen cannula (22-24Fr) or two small single vessel cannulas (15-19 Fr), allowing a blood flow rate between 1-1.75 L/min. Conventional care in the control arm includes invasive mechanical ventilation and the attempt to extubate the patient as early as possible and to switch to non-invasive ventilation (NIV). If extubation fails, tracheostomy can be performed according to the discretion of the treating physician.

Conditions

• COPD Exacerbation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-02-07
• Primary completion: 2024-11-01
• Completion: 2024-11-25
• First posted: 2018-07-12
• Last updated: 2025-03-14

Locations

1 site across 1 country: Germany