Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
The Effect of Treatment of Emphysema With Endobronchial Valves on the Diaphragm Mobility
NCT number | NCT06163131 |
Other study ID # | KH02 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | November 27, 2023 |
Est. completion date | April 1, 2027 |
Verified date | November 2023 |
Source | Aarhus University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
In some patients with chronic obstructive pulmonary disease (COPD) the breathlessness is caused by hyperinflation of the lungs. This causes difficulty breathing air out and makes it harder to breath in new air and limits the movement of the diaphram. The diaphragm is the muscle used for breathing between the chest and the stomach. Some of these patients can receive treatment with endobronchial valves, where one-ways are inserted into the bronchial system the let out some of the excess air, and thereby relieve breathlessness. The goal of this observational study is to investigate the effect of endobronchial valves on the mobility of the diaphragm in patients with chronic obstructive pulmonary disease. The main questions it aims to answer are: - If the movement of the diaphragm improves after treatment with endobronchial valves. - If there is a link between improvement of diaphragm function and improvement of symptoms, lung function and physical ability. - If ultrasound scan immediately after the treatment will predict which patients will benefit from the treatment. Participants will undergo ultrasound before, 1 day after and 90 days after the procedure, and lung function examinations from their already planned control visits will be collected.
Status | Recruiting |
Enrollment | 35 |
Est. completion date | April 1, 2027 |
Est. primary completion date | November 27, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Patients selected to receive treatment with endobronchial valves 2. Signed informed consent Exclusion Criteria: 1. Neuromuscular disease interfering with diaphragm function 2. Pleural effusion at time of preoperative or 90-days postoperative ultrasound |
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus University Hospital | Aarhus |
Lead Sponsor | Collaborator |
---|---|
Aarhus University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diaphragm mobility | The area method[13] will be used for assessment of diaphragm movement, using a curvilinear probe (2-6 MHz). Measurements will be performed during tidal respiration, deep respiration, sniff excursion and constant flow with constant volume, using test flute with bag of air attached. | Before the procedure, 1 day after the procedure and 90 days after the procedure | |
Primary | Diaphragm mobility | M-mode: Diaphragm excursion in tidal, deep and sniff inspiration will be evaluated in the right side using M-mode through anterior subcostal midclavicular view. Contraction and relaxation velocity will be measured. | Before the procedure, 1 day after the procedure and 90 days after the procedure | |
Primary | Diaphragm Thickening | Thickness and thickening ratio: The thickness and thickening ratio will be evaluated in B-mode using the linear probe, though lateral intercostal view during tidal respiration. | Before the procedure, 1 day after the procedure and 90 days after the procedure | |
Secondary | Forced expiratory volume in 1 second in litres | Patients will undergo lung function examinations as a part of the independent preoperative and postoperative assessments | Before and 90 days after the procedure | |
Secondary | Forced expiratory volume in 1 second % of expected | Patients will undergo lung function examinations as a part of the independent preoperative and postoperative assessments | Before and 90 days after the procedure | |
Secondary | Forced vital capacity in litres | Patients will undergo lung function examinations as a part of the independent preoperative and postoperative assessments | Before and 90 days after the procedure | |
Secondary | Forced vital capacity in % of expected | Patients will undergo lung function examinations as a part of the independent preoperative and postoperative assessments | Before and 90 days after the procedure | |
Secondary | Total lung volume in % of expected | Patients will undergo lung function examinations as a part of the independent preoperative and postoperative assessments | Before and 90 days after the procedure | |
Secondary | Residual volume in % of expected | Patients will undergo lung function examinations as a part of the independent preoperative and postoperative assessments | Before and 90 days after the procedure | |
Secondary | diffusion capacity in % of expected | Patients will undergo lung function examinations as a part of the independent preoperative and postoperative assessments | Before and 90 days after the procedure | |
Secondary | 6 Minute walking test | Patients will undergo 6 minutes walking test as a part of the independent preoperative and postoperative assessments | Before and 90 days after the procedure | |
Secondary | Rate of atelectasis on Lung X-ray | Patients will receive x ray of the lungs as a part of the independent preoperative and postoperative assessments | Before, one day and 90 days after the procedure | |
Secondary | Medical Research Council (MRC) Dyspnoea Scale | Medical Research Council (MRC) score will be used for symptom burden assessment | Before, one day and 90 days after the procedure | |
Secondary | COPD Assessment Test (CAT) Score | CAT score will be used for symptom burden assessment | Before, one day and 90 days after the procedure |
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