Comparison of the Airway Clearance Efficacy of Electro Flo 5000 and Vest Therapy in
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
- 主要终点
- Wet Sputum Weight
研究概览
简要总结
It is the goal of the proposed study to compare the efficacy, as assessed primarily by sputum weight, of these two different devices (the Electroflo 500 and VEST therapy) for airway clearance (AC) in CF patients with mild to moderate lung disease, who have stable lung health and perform AC at home as part of their routine therapeutic regimen.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of CF established by standard criteria (sweat chloride > 60 mmol/L and/or two alleles affected by gene mutations know to be associated with CF).
- •Age older than 12 years.
- •Known to consistently produce sputum.
- •Currently on a home therapeutic regimen that includes some form of AC performed at least 2 times daily.
- •FVC and FEV1 > 40%-predicted, and with stable lung function (no greater than a 10% variation in lung function parameters over the preceding 3 months).
排除标准
- •Hospitalization for CF pulmonary complications in the 2 months preceding enrollment.
- •Hemoptysis > 60 cc in a single episode in the 4 weeks preceding enrollment.
- •Chronic chest pain.
- •Participation in another interventional clinical trial in the previous 30 days. -
结局指标
主要结局
Wet Sputum Weight
时间窗: End of study visit per intervention
Sputum was collected in pre-measured cups in a blinded fashion
Pulmonary Function Measured as a Percent Predicted BEFORE Therapy With Either ElectroFlo 5000 / VEST.
时间窗: End of study visit per intervention
Comparison of pulmonary function by doing spirometry testing on study patients during their Day 1 \& Day 2 therapy sessions. Will also compare the results based on the therapies they receive.
Pulmonary Function Measured as a Percent Predicted AFTER Therapy With Either ElectroFlo 5000 / Vest.
时间窗: End of study visit per intervention
Comparison of pulmonary function by doing spirometry testing on study patients during their Day 1 \& Day 2 therapy sessions. Will also compare the results based on the therapies they receive.
Comfort Level After Receiving Therapy With Either ElectroFlo 5000 / Vest
时间窗: End of study visit per intervention
Comfort assessed on a scale of 1-10 by patients after therapy after each visit (1 being most comfortable, 10 being most un-comfortable)
次要结局
- Dry Sputum Weight(End of study visit per intervention)
研究者
Carlos Milla
Principal Investigator
Stanford University