NCT01510275已完成不适用
Efficacy on Combined Use of Respiratory Devices RESPILIFT® and RESPIVOL® in Adult Cardio-thoracic Surgery Patients. Randomized-controlled Study
Villa Pineta Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Respiratory muscle performance
研究概览
简要总结
In a rehabilitation setting, respiratory muscle training with re-expansion techniques in patients following cardio-thoracic surgery represents a consolidated intervention. New devices called RESPILIFT® and RESPIVOl® improve deep inspiration and pulmonary volume with an effect on respiratory muscle performance and perceived dispnoea. The aim of the investigators study is to test the clinical efficacy of RESPILIFT® and RESPIVOl® in patients with a recent history of cardio-thoracic surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 years old
- •recent cardio-thoracic surgery (< 30 days of admission)
- •compliance to pulmonary rehabilitation program
排除标准
- •clinical instability
- •concomitant severe co-morbidities
- •inability to use respiratory devices
结局指标
主要结局
Respiratory muscle performance
时间窗: Change from Baseline in MEP at 6 months
Change of MEP (Maximum Expiratory Pressure)measure
次要结局
- Respiratory muscle performance(Enrollment (T0), Day 8 (T8), at the end (T14) and after 6 months (T6m))
- Pulmonary gas exchange(Enrollment (T0), at the end (T14) and after 6 months (T6m))
- Pulmonary volumes(Enrollment (T0), Day 8 (T8), at the end (T14) and after 6 months (T6m))
- Perceived dispnoea, well being and thoracic pain(At enrollment (T0), every day during the treatment (T2,T4, T6, T8, T10, T12), at the end (T14) and after 6 months (T6m))
- Perceived quality of life(Enrollment (T0), at the end (T14) and after 6 months (T6m))
研究者
Prof. Clini Enrico
Prof.
Villa Pineta Hospital
研究点 (2)
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