Effects of Endoscopic Lung Volume Reduction on Diaphragm Function and Conformation

COPD Clinical Trial

Official title:

Effects of Endoscopic Lung Volume Reduction on Diaphragm Function and Conformation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05799352
• Other study ID #: P2018/227
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: December 2023

Study information

• Verified date: March 2023
• Source: Erasme University Hospital
• Contact: Olivier Taton
• Phone: 025553943
• Email: olivier.taton[@]hubruxelles.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• valves insertion

Exclusion Criteria:

• TLVR < 50 %

Related Conditions & MeSH terms

• COPD

Intervention

Device:
• Endoscopic lung volume reduction
a prospective monocentric study on hyperinflated COPD patients without collateral ventilation. Patients were evaluated before and 3 months after unilateral ELVR by transdiaphragmatic pressure (Pdi) measured at the functional residual capacity (FRC) after magnetic phrenic stimulation and by high-resolution computed tomography at the FRC allowing 3D modelling of the diaphragm for measurements of fibers length, length of the zone of apposition and radius of curvature of the diaphragmatic domes.

Locations

Country	Name	City	State
Belgium	Erasme Hospital	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transdiaphragmatic pressure	evaluate the difference in diaphragmatic function, assessed by the transdiaphragmatic pressure, before and 3 months after unilateral valves setting	before until 3 months after the valves insertion
Primary	Diaphragmatic conformation	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.	before until 3 months after the valves insertion