The Effect of Treatment of Emphysema With Endobronchial Valves on the Diaphragm Mobility
- Conditions
- Emphysema or COPDChronic Obstructive Pulmonary Disease
- Registration Number
- NCT06163131
- Lead Sponsor
- Aarhus University Hospital
- Brief Summary
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.
- Detailed Description
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:
1. If the movement of the diaphragm improves after insertion of endobronchial valves in patients with severe emphysema.
2. If there is a correlation between improvement of diaphragm function and improvement of symptoms, lung function examinations and physical ability after insertion of endobronchial valves.
3. If immediate post-procedural ultrasound evaluation of diaphragm function predicts the development of atelectasis and hence clinical outcome
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 35
- Patients selected to receive treatment with endobronchial valves
- Signed informed consent
- Neuromuscular disease interfering with diaphragm function
- Pleural effusion at time of preoperative or 90-days postoperative ultrasound
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diaphragm mobility Before the procedure, 1 day after the procedure and 90 days after the procedure 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.
Diaphragm Thickening Before the procedure, 1 day after the procedure and 90 days after the procedure 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.
- Secondary Outcome Measures
Name Time Method Forced expiratory volume in 1 second in litres Before and 90 days after the procedure Patients will undergo lung function examinations as a part of the independent preoperative and postoperative assessments
Forced expiratory volume in 1 second % of expected Before and 90 days after the procedure Patients will undergo lung function examinations as a part of the independent preoperative and postoperative assessments
Total lung volume in % of expected Before and 90 days after the procedure Patients will undergo lung function examinations as a part of the independent preoperative and postoperative assessments
Residual volume in % of expected Before and 90 days after the procedure Patients will undergo lung function examinations as a part of the independent preoperative and postoperative assessments
6 Minute walking test Before and 90 days after the procedure Patients will undergo 6 minutes walking test as a part of the independent preoperative and postoperative assessments
Medical Research Council (MRC) Dyspnoea Scale Before, one day and 90 days after the procedure Medical Research Council (MRC) score will be used for symptom burden assessment
Forced vital capacity in litres Before and 90 days after the procedure Patients will undergo lung function examinations as a part of the independent preoperative and postoperative assessments
diffusion capacity in % of expected Before and 90 days after the procedure Patients will undergo lung function examinations as a part of the independent preoperative and postoperative assessments
COPD Assessment Test (CAT) Score Before, one day and 90 days after the procedure CAT score will be used for symptom burden assessment
Forced vital capacity in % of expected Before and 90 days after the procedure Patients will undergo lung function examinations as a part of the independent preoperative and postoperative assessments
Rate of atelectasis on Lung X-ray Before, one day and 90 days after the procedure Patients will receive x ray of the lungs as a part of the independent preoperative and postoperative assessments
Trial Locations
- Locations (1)
Aarhus University Hospital
🇩🇰Aarhus, Denmark
Aarhus University Hospital🇩🇰Aarhus, Denmark