The Effect of Treatment of Emphysema With Endobronchial Valves on the Diaphragm Mobility
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Diaphragm mobility
研究概览
简要总结
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.
详细描述
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:
- If the movement of the diaphragm improves after insertion of endobronchial valves in patients with severe emphysema.
- 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.
- If immediate post-procedural ultrasound evaluation of diaphragm function predicts the development of atelectasis and hence clinical outcome
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients selected to receive treatment with endobronchial valves
- •Signed informed consent
排除标准
- •Neuromuscular disease interfering with diaphragm function
- •Pleural effusion at time of preoperative or 90-days postoperative ultrasound
结局指标
主要结局
Diaphragm mobility
时间窗: 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
时间窗: 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.
次要结局
- Forced expiratory volume in 1 second in litres(Before and 90 days after the procedure)
- Forced expiratory volume in 1 second % of expected(Before and 90 days after the procedure)
- Total lung volume in % of expected(Before and 90 days after the procedure)
- Residual volume in % of expected(Before and 90 days after the procedure)
- 6 Minute walking test(Before and 90 days after the procedure)
- Medical Research Council (MRC) Dyspnoea Scale(Before, one day and 90 days after the procedure)
- Forced vital capacity in litres(Before and 90 days after the procedure)
- diffusion capacity in % of expected(Before and 90 days after the procedure)
- COPD Assessment Test (CAT) Score(Before, one day and 90 days after the procedure)
- Forced vital capacity in % of expected(Before and 90 days after the procedure)
- Rate of atelectasis on Lung X-ray(Before, one day and 90 days after the procedure)
研究者
Kirstine Hermann
Principal Investigator
Aarhus University Hospital