Actively Recruiting
The Effect of Treatment of Emphysema With Endobronchial Valves on the Diaphragm Mobility
Led by Aarhus University Hospital · Updated on 2023-12-08
35
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effects of endobronchial valve treatment on diaphragm mobility in patients with chronic obstructive pulmonary disease (COPD) who experience breathlessness due to lung hyperinflation. This observational study aims to understand if diaphragm movement improves after valve treatment, its relationship with symptoms, lung function, and physical ability, and whether ultrasound right after treatment can predict patient benefit. Participants in this study are patients with severe emphysema undergoing treatment by insertion of one-way endobronchial valves into the bronchial system. These valves allow excess air to escape, reducing lung hyperinflation and potentially improving breathing. The study involves ultrasound examinations of the diaphragm before the procedure, one day after, and 90 days after valve insertion, alongside the collection of lung function tests from routine control visits. During their participation, patients will receive diaphragm ultrasound scans at three time points and have lung function tests including forced expiratory volume, vital capacity, lung volume, and diffusion capacity measured before and 90 days post-procedure. Additional assessments include a 6-minute walking test, lung X-rays to check for atelectasis, and questionnaires about breathlessness and COPD symptoms. The study will monitor changes over three months to evaluate diaphragm function and clinical outcomes following endobronchial valve treatment.
CONDITIONS
Brief Title
The Effect of Treatment of Emphysema With Endobronchial Valves on the Diaphragm Mobility
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients selected to receive treatment with endobronchial valves
- Signed informed consent
You will not qualify if you...
- Neuromuscular disease interfering with diaphragm function
- Pleural effusion at time of preoperative or 90-days postoperative ultrasound
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for assessment and consent
Duration - Procedure day plus immediate recovery
Participants undergo insertion of endobronchial valves to reduce lung hyperinflation and improve diaphragm mobility.
1 procedure visit (in-person)
Duration - 90 days
Participants are assessed to evaluate diaphragm mobility, lung function, symptoms, and physical ability after valve insertion.
3 visits (before procedure, 1 day after, and 90 days after procedure)
Trial Site Locations
Total: 1 location
1
Aarhus University Hospital
Aarhus, Denmark, 8200
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here