Effects of Endoscopic Lung Volume Reduction on Diaphragm Function and Conformation

Not Applicable

Recruiting

• Conditions: COPD

• Registration Number: NCT05799352
• Lead Sponsor: Erasme University Hospital

Brief Summary

Chronic obstructive lung disease (COPD) is a common disease that is frequently complicated by hyperinflation. The resulting increase in lung volume impairs the diaphragmatic function because of a shortening of the diaphragmatic fibers and an increase in the radius of curvature of the diaphragmatic domes. Lung volume reduction surgery (LVRS) has already shown an improvement in diaphragmatic function that could be explained by a change of the diaphragm conformation. More recently, endoscopic lung volume reduction (ELVR) has shown benefits in terms of respiratory function, exercise capacity and quality of life, but the mechanisms of these improvements are poorly understood. Therefore, we aim to evaluate the evolution of the diaphragmatic function and the changes in diaphragmatic conformation after unilateral ELVR.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2023-03-23
• Study First Submitted QC: 2023-03-23
• Study First Posted: 2023-04-05
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-28
• Primary Completion: 2025-01-30
• Study Completion: 2025-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• valves insertion

Exclusion Criteria

• TLVR < 50 %

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Transdiaphragmatic pressure	before until 3 months after the valves insertion	evaluate the difference in diaphragmatic function, assessed by the transdiaphragmatic pressure, before and 3 months after unilateral valves setting
Diaphragmatic conformation	before until 3 months after the valves insertion	evaluate the change of the diaphragm conformation, by measuring diaphragmatic fibers length in several planes, diaphragmatic area and radius of curvature, before and 3 months after unilateral ELVR.

Trial Locations

Locations (1)

Erasme Hospital; 🇧🇪 Brussels, Belgium