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NCT06702072: CROCODILE

Change in Task-related Oxygen Uptake After EBV Treatment

Not yet recruiting Last updated 26 November 2024
What this trial tests

trial testing Endobronchial valve treatment in COPD in 20 participants. Not yet recruiting.

Timeline
1 May 2025
Primary endpoint
1 August 2026
1 August 2026

Quick facts

Lead sponsorDirk-Jan Slebos
StatusNot yet recruiting
Study typeOBSERVATIONAL
Enrollment20
Start date1 May 2025
Primary completion1 August 2026
Estimated completion1 August 2026
Sites1 location across Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

Dirk-Jan Slebos

Who can join

Eligibility, any sex, with COPD. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Rationale: Bronchoscopic lung volume reduction using endobronchial valves (EBV) has emerged as a viable treatment option for eligible patients with severe emphysema. In all studies conducted so far, exercise capacity has only been measured using the 6-minute walk distance test (6MWT). It is known that patients with COPD frequently experience problems during ADL, which can lead to avoidance of or care dependency for performing certain tasks and have a significant social impact on their lives. Patients report that it is easier to perform ADLs after EBV treatment. Previously it was found that it was easier for patient to perform these activities after the EBV treatment. However, the physiological load during these ADLs has never been investigated before. Potentially, EBV treatment could improve the metabolic load and consequently symptom perception, thus enhancing the execution of ADLs, which is an important patient-centred outcome. However, this has not been investigated so far. Objective: To investigate the change in exercise physiology during daily activities after EBV treatment. Study design: Observational study in which the study population will be asked to perform some additional test during regular visits for the bronchoscopic lung volume reduction treatment with valves. Study population: Patients with emphysema who are scheduled for a bronchoscopic lung volume reduction treatment using endobronchial valves. Intervention: Not applicable Main study parameters: The change in task-related oxygen uptake measured with a mobile oxygen device during activities of daily life 6 months after EBV treatment.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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