Effects of Endoscopic Lung Volume Reduction on Diaphragm Function and Conformation

Sponsor

Erasme University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05799352

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COPD	Device: Endoscopic lung volume reduction	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Before and after studyBefore and after study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effects of Endoscopic Lung Volume Reduction on Diaphragm Function and Conformation

Actual Study Start Date :

Apr 1, 2019

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Endoscopic lung volume reduction All the patients will have endobronchial valves insertion. We will evaluate before and 3 months after the evolution of the diaphragmatic strength and conformation.	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.

Arm

Intervention/Treatment

Experimental: Endoscopic lung volume reduction

All the patients will have endobronchial valves insertion. We will evaluate before and 3 months after the evolution of the diaphragmatic strength and conformation.

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

valves insertion

Exclusion Criteria:

TLVR < 50 %

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Erasme Hospital	Brussels		Belgium	1070

Sponsors and Collaborators

Erasme University Hospital

Investigators

Principal Investigator: Olivier Taton, Hôpital Erasme, Université Libre de Brussels, Brussels, Belgium

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Olivier Taton, Doctor, Erasme University Hospital

ClinicalTrials.gov Identifier:

NCT05799352

Other Study ID Numbers:

P2018/227

First Posted:

Apr 5, 2023

Last Update Posted:

Apr 5, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 5, 2023