DIAMANT: Assessing the DIAphragM Before ANd After Endobronchial Valve Treatment

Sponsor

University Medical Center Groningen (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04735731

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Rationale:

The diaphragm is the principal respiratory muscle, which separates the thorax from the abdomen. Hyperinflation of the lung places the diaphragm at a mechanical disadvantage, shortens its operating length and changes the mechanical arrangement of costal and crural components of the diaphragm and consequently decrease the tension that can be developed and the amount of transdiaphragmatic pressure that can be produced. Reducing the lung hyperinflation could improve the diaphragm function mechanically. One of the treatments to reduces lung hyperinflation is the bronchoscopic treatment using endobronchial valves. To our knowledge the change in diaphragm function after bronchoscopic endobronchial valve treatment was never investigated.

Objective:

To investigate the change in diaphragm function after bronchoscopic lung volume reduction treatment with endobronchial valves (EBV).

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.

Main study parameters: Change in diaphragm function 6 week after EBV treatment measured by ultrasound. The main outcome will be diaphragm motion (difference between maximum in- and expiration).

Condition or Disease	Intervention/Treatment	Phase
Emphysema	Diagnostic Test: Echography

Study Design

Study Type:

Observational

Anticipated Enrollment :

25 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Assessing the DIAphragM Before ANd After Endobronchial Valve Treatment

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
EBV-patients Patients who are scheduled for a bronchoscopic lung volume reduction treatment using endobronchial valves	Diagnostic Test: Echography Echography of diaphragma and other respiratory muscles

Arm

Intervention/Treatment

EBV-patients

Patients who are scheduled for a bronchoscopic lung volume reduction treatment using endobronchial valves

Diagnostic Test: Echography

Echography of diaphragma and other respiratory muscles

Outcome Measures

Primary Outcome Measures

Change in diaphragm motion measured by ultrasound [6 weeks]
Change in diaphragm motion 6 week after EBV treatment measured by ultrasound.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient is scheduled for a bronchoscopic lung volume treatment using one-way valves
Patient read, understood and signed the Informed Consent Form

Exclusion Criteria:

There are no exclusion criteria for this study.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Medical Center Groningen

Investigators

Principal Investigator: Dirk-Jan Slebos, PhD, University Medical Center Groningen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dirk-Jan Slebos, MD PhD, University Medical Center Groningen

ClinicalTrials.gov Identifier:

NCT04735731

Other Study ID Numbers:

DIAMANT-study

First Posted:

Feb 3, 2021

Last Update Posted:

Apr 20, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

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

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

Additional relevant MeSH terms:

Emphysema

Study Results

No Results Posted as of Apr 20, 2022