Tracheobronchomalacia: Treatment Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- To evaluate the effect of central airway stabilization on symptoms and quality of life in patients with symptomatic and severe tracheobronchomalacia.
研究概览
简要总结
The purpose of this study is to evaluate respiratory symptoms and their impact in the quality of life and after treatment of the respiratory condition (tracheobronchomalacia - TBM).
详细描述
TBM is an abnormal collapse of the tracheal and bronchial walls. It is characterized by flaccidity of the supporting tracheal and bronchial structures and a significant reduction of airway diameter on expiration seen in the trachea and/or in the mainstem bronchi. Currently there is no available data on the efficacy of central airway stabilization for treating TBM.
Our study would provide this important information and would establish the effect of central airway stabilization on symptoms, functional status, quality of life, lung function and exercise capacity in patients with symptomatic and severe TBM.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspicion of symptomatic tracheal and/or bronchial collapse during bronchoscopy or Dynamic Computed Tomographic study.
- •Chronic Obstructive Pulmonary Disease (regardless of severity) and suspicion of tracheal and/or bronchial collapse
排除标准
- •inability to follow commands
- •Focal extrinsic compression of the trachea/bronchi by mass or other
结局指标
主要结局
To evaluate the effect of central airway stabilization on symptoms and quality of life in patients with symptomatic and severe tracheobronchomalacia.
时间窗: At 10-14 days post-stent ; at 3 months and yearly post-tracheobronchoplasty
次要结局
- To evaluate the effect of central airway stabilization on lung function, exercise capacity and functional status.(At 10-14 days post-stent ; at 3 months and yearly post-tracheobronchoplasty)