NCT00689234Unknown不适用
Diaphragm Plication in Adults With Phrenic Nerve Paralysis: a Randomised Controlled Study
适应症
试验速览
- 阶段
- 不适用
- 发起方
- KU Leuven
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Dyspnea
研究概览
简要总结
The purpose of the study is to investigate the impact of unilateral or bilateral diaphragm plication in a prospective randomised controlled way on symptoms, pulmonary function including gas exchange, respiratory muscle strength, exercise capacity and breathing during sleep in patients with proven uni- or bilateral phrenic nerve paralysis present for at least 1 year without any evidence of spontaneous recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Uni- or bilateral diaphragmatic paralysis due to phrenic nerve paralysis present for at least 1 year
- •With reduced VC, at least in supine position and no significant change in VC for at least 6 months
- •At the time of randomisation symptomatic patient, defined by one of the following symptoms: not able to sleep in supine position or exertional dyspnoea
排除标准
- •No informed consent obtained
- •Other disease that may interfere with the evaluation of pulmonary function or the exercise capacity: COPD, parenchymal lung disease on the thoracic X-ray, documented ischemic heart disease or left heart failure, active rheumatological disease, severe orthopaedic problems,....
- •Abnormal neuromuscular clinical investigation (apart from diaphragmatic dysfunction) and/or abnormal electromyography of the limbs compatible with generalized neuromuscular disease
- •Known diseases resulting in abnormal blood coagulation
- •Proven oncological origine of the phrenic nerve paralysis
- •Age below 18 yrs old
结局指标
主要结局
Dyspnea
时间窗: 12 months after inclusion
Functional outcome measured by dyspnea score
Exercise capacity
时间窗: 12 months after inclusion
Functional outcome measured by exercise testing
次要结局
- Pulmonary function(12 months after inclusion)
- Sleep(12 months after inclusion)
研究者
研究点 (2)
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