To investigate the change in diaphragm function after bronchoscopic lung volume reduction treatment with endobronchial valves (EBV).
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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).
Secondary outcome
• Change in diaphragm function 6 week after EBV treatment measured by
ultrasound (other ultarsound outcomes than the main outcome).
• Change in diaphragm function 3 days after EBV treatment measured by
ultrasound.
• Change in diaphragm function 6 weeks after EBV treatment measured by
quantified CT-analysis.
• Change in diaphragm function 6 weeks after EBV treatment measured by EMG.
• Change in respiratory muscle function 6 weeks after EBV treatment measured by
ultrasound.
• Change in respiratory muscle function 6 weeks after EBV treatment measured by
EMG.
• Change in respiratory muscle function 6 weeks after EBV treatment measured by
MIP/MEP.
• Change in skeletal muscle function 6 weeks after EBV treatment measured by
ultrasound.
• Change in skeletal muscle function 6 months after EBV treatment measured by
ultrasound.
• Change in exercise capacity 6 weeks after EBV treatment measured by 6MWD and
30STS.
• Change in exercise capacity 6 months after EBV treatment measured by 6MWD and
30STS.
• Change in ventilation distribution of the lungs 6 weeks after EBV treatment
measured using XV Lung Ventilation Analysis Software (XV LVAS).
• Association between change in diaphragm function and change in lung
hyperinflation measured by bodyplethysmography or CT-scans.
• Association between change in diaphragm function and change in respiratory
muscle function measured by EMG or ultrasound.
• Association between change in diaphragm function and change dyspnea severity.
• Association between change in diaphragm function and change in level of
fatigue.
• Association between change in diaphragm function and skeletal muscle function.
• Association between change in diaphragm function and exercise capacity.
• Association between change in diaphragm function and change in ventilation
distribution.
Background summary
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 reduce lung hyperinflation is the bronchoscopic treatment using
endobronchial valves. To our knowledge the change in diaphragm function after
bronchoscopic endobronchial valve treatment has never been investigated.
Study 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.
Study burden and risks
This study has no specific benefits for the participating patients and the
study also has no major risks.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04735731 |
| CCMO | NL76676.042.21 |