Pilot, Single Center Study of Ambulatory Respiratory Assist Device in Chronic Obstructive Pulmonary Disease Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Assess distance travelled during 6-minute walk tests performed with and without device.
研究概览
简要总结
The study is a two-part small scale, open-label, pilot study to evaluate feasibility and proof-of-concept for a respiratory assist medical device. The study population will consist of severe Chronic Obstructive Pulmonary Disease (COPD) subjects.
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
- •Moderate to severe COPD (by ATS criteria)
- •FEV1/FVC <0.70
- •FEV1 < 60% Predicted
排除标准
- •Physical limitation that prevents walking for 6 minutes (e.g. lower extremity amputation, arthritis limiting function, significant angina, etc...)
- •Lung pathology not explained by COPD, which may limit functional capacity (e.g. pulmonary fibrosis, malignancy, history of lung reduction surgery, etc...)
研究组 & 干预措施
Part 1: Feasibility
Patients will perform 6-minute walk test with AIR-AD to allow for observation and real-time feedback.
干预措施: AIR-AD (Device)
Part 2: Crossover
Crossover design where investigator will compare wearing of AIR-AD during exercise to compare distance walked with and without it.
干预措施: AIR-AD (Device)
结局指标
主要结局
Assess distance travelled during 6-minute walk tests performed with and without device.
时间窗: 6 months
Distances travelled during two six minute walk tests will be measured. Investigator will compare distance travelled with use of the device to the distance travelled without the use of the device.
次要结局
- Assess for patient improvement in shortness of breath scores(6 months)