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Assessing the DIAphragM Before ANd After Endobronchial Valve Treatment

Assessing the DIAphragM Before ANd After Endobronchial Valve Treatment

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04735731
Acronym
DIAMANT
Enrollment
25
Registered
2021-02-03
Start date
2023-01-28
Completion date
2024-02-13
Last updated
2024-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emphysema

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).

Interventions

DIAGNOSTIC_TESTEchography

Echography of diaphragma and other respiratory muscles

Sponsors

University Medical Center Groningen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in diaphragm motion measured by ultrasound6 weeksChange in diaphragm motion 6 week after EBV treatment measured by ultrasound.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026