Assessing the DIAphragM Before ANd After Endobronchial Valve Treatment

Completed

• Conditions: Emphysema
• Interventions: Diagnostic Test: Echography

• Registration Number: NCT04735731
• Lead Sponsor: University Medical Center Groningen

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-29
• Study First Submitted QC: 2021-01-29
• Study First Posted: 2021-02-03
• Study Start: 2023-01-28
• Status Verified: 2024-02
• Primary Completion: 2024-02-13
• Study Completion: 2024-02-13
• Last Update Submitted: 2024-02-14
• Last Update Posted: 2024-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

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

Exclusion Criteria

There are no exclusion criteria for this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EBV-patients	Echography	Patients who are scheduled for a bronchoscopic lung volume reduction treatment using endobronchial valves

Primary Outcome Measures

Name	Time	Method
Change in diaphragm motion measured by ultrasound	6 weeks	Change in diaphragm motion 6 week after EBV treatment measured by ultrasound.

Trial Locations

Locations (1)

UMCG Groningen; 🇳🇱 Groningen, Netherlands