The Humanatarian Use of the Spiration IBV® Valve System and Spiration Airway Sizing Kit for Use in Patients at The Ohio State University Medical Center.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- resolution of BPF (Bronchopleural Fistulae)
研究概览
简要总结
This procedure allows patients to use the Humanitarian Use Device, IBV® Valve System.
详细描述
IBV® Valve System The Spiration® IBV Valve System is a device to control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks following lobectomy, segmentectomy, or lung volume reduction surgery (LVRS). An air leak present on postoperative day 7 is considered prolonged unless present only during forced exhalation or cough. An air leak present on day 5 should be considered for treatment if it is: 1) continuous, 2) present during normal inhalation phase of inspiration, or 3) present upon normal expiration and accompanied by subcutaneous emphysema or respiratory compromise. IBV Valve System use is limited to 6 weeks per prolonged air leak.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unresolved BPF
- •Not candidate for surgical repair
排除标准
- 未提供
结局指标
主要结局
resolution of BPF (Bronchopleural Fistulae)
时间窗: 6 weeks
expected resolution of BPF (Bronchopleural Fistulae) in three weeks
resolutin of BPF
时间窗: 6 weeks
anticipated the with the use of valves the BPF would improve and the valves can be removed in 6 weeks
次要结局
未报告次要终点
