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Clinical Trials/NCT04735731
NCT04735731CompletedNot Applicable

Assessing the DIAphragM Before ANd After Endobronchial Valve Treatment

University Medical Center Groningen1 site in 1 country25 target enrollmentStarted: January 28, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
25
Locations
1
Primary Endpoint
Change in diaphragm motion measured by ultrasound

Study Overview

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).

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Change in diaphragm motion measured by ultrasound

Time Frame: 6 weeks

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dirk-Jan Slebos

MD PhD

University Medical Center Groningen

Study Sites (1)

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