Assessing the DIAphragM Before ANd After Endobronchial Valve Treatment

Emphysema Clinical Trial

— DIAMANT  

Official title:

Assessing the DIAphragM Before ANd After Endobronchial Valve Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04735731
• Other study ID #: DIAMANT-study
• Status: Completed
• Start date: January 28, 2023
• Est. completion date: February 13, 2024

Study information

• Verified date: February 2024
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 13, 2024
• Est. primary completion date: February 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Emphysema

Intervention

Diagnostic Test:
• Echography
Echography of diaphragma and other respiratory muscles

Locations

Country	Name	City	State
Netherlands	UMCG Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in diaphragm motion measured by ultrasound	Change in diaphragm motion 6 week after EBV treatment measured by ultrasound.	6 weeks