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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:
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.
When emphysema is present in COPD-patients, the impaired expiratory ventilation causes lung hyperinflation. This results in a change in the respiratory mechanisms of the thorax and thereby impairment of the movement capacity of the muscles. The most important respiratory muscle, the diaphragm, is caudally displaced and flattened, hence, the capacity and mobility of the muscle decreases.
Some patients with COPD fulfill the criteria for treatment with endobronchial valves (EBV) where one-way valves can be inserted in the bronchial system. The mechanism behind the effect of EBV is believed to be formation of an atelectasis of the designated lobe and thereby reduction of hyperinflation and hence reduction of symptoms and increase in pulmonary function
In this study the aim is to assess:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | COPD patients treated with endobronchial valves. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Forced expiratory volume in 1 second % of expected |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with COPD approved for treatment with endobronchial valves. The suitability will be assessed during multidiciplinary team conference, independent of this study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Recruiting | Aarhus | 8200 | Denmark |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D004646 | Emphysema |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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Patients will undergo lung function examinations as a part of the independent preoperative and postoperative assessments |
| Before and 90 days after the procedure |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| COPD Assessment Test (CAT) Score | CAT score will be used for symptom burden assessment | Before, one day and 90 days after the procedure |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |