The Effect of Treatment of Emphysema With Endobronchial Valves on the Diaphragm Mobility
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Obstructive Pulmonary Disease, Emphysema or COPD. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Primary outcome measures
- Diaphragm mobility [Time frame: Before the procedure, 1 day after the procedure and 90 days after the procedure]
- Diaphragm mobility [Time frame: Before the procedure, 1 day after the procedure and 90 days after the procedure]
- Diaphragm Thickening [Time frame: Before the procedure, 1 day after the procedure and 90 days after the procedure]
Secondary outcome measures (11)
- Forced expiratory volume in 1 second in litres [Time frame: Before and 90 days after the procedure]
- Forced expiratory volume in 1 second % of expected [Time frame: Before and 90 days after the procedure]
- Forced vital capacity in litres [Time frame: Before and 90 days after the procedure]
- Forced vital capacity in % of expected [Time frame: Before and 90 days after the procedure]
- Total lung volume in % of expected [Time frame: Before and 90 days after the procedure]
- Residual volume in % of expected [Time frame: Before and 90 days after the procedure]
- diffusion capacity in % of expected [Time frame: Before and 90 days after the procedure]
- 6 Minute walking test [Time frame: Before and 90 days after the procedure]
- Rate of atelectasis on Lung X-ray [Time frame: Before, one day and 90 days after the procedure]
- Medical Research Council (MRC) Dyspnoea Scale [Time frame: Before, one day and 90 days after the procedure]
- COPD Assessment Test (CAT) Score [Time frame: Before, one day and 90 days after the procedure]
Eligibility criteria
Inclusion criteria
- Patients selected to receive treatment with endobronchial valves
- Signed informed consent
Exclusion criteria
- Neuromuscular disease interfering with diaphragm function
- Pleural effusion at time of preoperative or 90-days postoperative ultrasound
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Denmark · 1 center
- Aarhus University Hospital — Aarhus
Identifiers
NCT: NCT06163131 · KH02