Assessing the DIAphragM Before ANd After Endobronchial Valve Treatment
NCT ID: NCT04735731
Last Updated: 2024-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
25 participants
OBSERVATIONAL
2023-01-28
2024-02-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Biological Investigation of Explanted Endobronchial Lung Valves Study
NCT04214587
Ultrasound of the Diaphragm Excursion Ratio as Physiological Biomarker in Acute Exacerbations of Chronic Obstructive Pulmonary Disease
NCT07259174
Upright MRI in Lung Disease
NCT03531775
Thorax MRI for Evaluation of Lung Morphology, Ventilation and Perfusion
NCT04719078
Sonographic Diaphragm Function in AECOPD
NCT05671198
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
EBV-patients
Patients who are scheduled for a bronchoscopic lung volume reduction treatment using endobronchial valves
Echography
Echography of diaphragma and other respiratory muscles
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Echography
Echography of diaphragma and other respiratory muscles
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patient read, understood and signed the Informed Consent Form
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Medical Center Groningen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dirk-Jan Slebos
MD PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dirk-Jan Slebos, PhD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Groningen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UMCG Groningen
Groningen, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DIAMANT-study
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.