Effect of High Frequency Chest Wall Oscillation Vests on Spirometry Measurements, Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Peak Expiratory Flow (PEF) Assessed in Participants at Baseline and With Both Devices
研究概览
简要总结
The impact of high-frequency chest wall oscillation therapy on spirometry values (Forced Expiratory Volume, Forced Vital Capacity, Peak Expiratory Flow, Forced Expiratory Flow and Tidal Volume is investigated during use of several products and comparing to baseline values
详细描述
The study will be broken into one (1) arm:
• AffloVest® & Monarch™
Within the arm, the order of products will be randomized.
Baseline spirometry (Forced Expiratory Volume (FEV1), Forced Vital Capacity (FVC), Peak Expiratory Flow (PEF), Forced Expiratory Flow (FEF25-75%) and Tidal Volume (TV)) will be taken at the beginning, middle and end of each series of measurements with each subject, without any device on the subject. A product (AffloVest or Monarch) will be placed onto subject and turned ON to the highest frequency and intensity settings. Then the subject will be given a certain period of time to adjust and spirometry measurements will then be repeated, then the product will be removed and the subject will be allowed a recovery period, then the other product will be placed on the subject, turned ON and spirometry measurements will repeated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subject, ages 18 - 50
排除标准
- •Non-ambulatory
- •diagnosed neuromuscular disorder
- •currently using any type of oscillation vest therapy
- •diagnosed co-morbid condition (i.e. lung cancer, other lung disorder or disease)
- •currently enrolled in a medical research study
- •non-English speaking
- •presence of the following active implantable devices: pacemakers, neurostimulators, infusion pumps, circulatory support devices, implantable cardioverter defibrillators (ICD's), cochlear implants
- •presence of head and/or neck injury that has not yet been stabilized
- •presence of active hemorrhage with hemodynamic instability
结局指标
主要结局
Peak Expiratory Flow (PEF) Assessed in Participants at Baseline and With Both Devices
时间窗: 30 minutes
Peak Expiratory Flow (PEF) measures the peak flow during a forced exhalation, measured using standard spirometry techniques
Forced Expiratory Volume (1 Second) Assessed in Participants at Baseline and With Both Devices
时间窗: 30 minutes
Forced Expiratory Volume in 1 second (FEV1) measures how much air a person can exhale during a forced breath during the first one (1) second, measured using standard spirometry techniques
Forced Vital Capacity (FVC) Assessed in Participants at Baseline and With Both Devices
时间窗: 30 minutes
Forced Vital Capacity (FVC) is the total amount of air exhaled during the FEV test, measured using standard spirometry techniques
Tidal Volume (TV) Assessed in Participants at Baseline and With Both Devices
时间窗: 30 minutes
Tidal Volume is the normal volume of air displaced between normal inhalation and exhalation, measured using standard sprirometry techniques
Forced Expiratory Flow (FEF25-75%) Assessed in Participants at Baseline and With Both Devices
时间窗: 30 minutes
Forced Expiratory Flow (25-75%) is the average flow from the point at which 25% of the FVC has been exhaled to the point at which 75% of the FVC has been exhaled, measured using standard spirometry techniques
次要结局
未报告次要终点