Effect of High Frequency Chest Wall Oscillation Vests on Spirometry Measurements
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- TV
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 three (3) arms:
- AffloVest® & The Vest®
- AffloVest® & inCourage®
- AffloVest® & SmartVest® Subjects will be randomly assigned to an arm. Within each arm, the order of products will be also 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 Compressor-based vest) 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
- Non Randomized
- 干预模型
- Parallel
- 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
研究组 & 干预措施
AffloVest The Vest Arm
Devices placed on highest intensity / highest frequency
干预措施: International Biophysics AffloVest (Device)
AffloVest The Vest Arm
Devices placed on highest intensity / highest frequency
干预措施: Hill-Rom The Vest (Device)
AffloVest inCourage Arm
Devices placed on highest intensity / highest frequency
干预措施: International Biophysics AffloVest (Device)
AffloVest inCourage Arm
Devices placed on highest intensity / highest frequency
干预措施: Respirtech inCourage (Device)
AffloVest SmartVest Arm
Devices placed on highest intensity / highest frequency
干预措施: International Biophysics AffloVest (Device)
AffloVest SmartVest Arm
Devices placed on highest intensity / highest frequency
干预措施: Electromed SmartVest (Device)
结局指标
主要结局
TV
时间窗: 30 minutes
Tidal Volume, the lung volume representing the normal volume of air displaced between normal inhalation and exhalation when extra effort is not applied
PEF
时间窗: 30 minutes
Peak Expiratory Flow, a person's maximum speed of expiration
FVC
时间窗: 30 minutes
Forced Vital Capacity, the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible
FEV1
时间窗: 30 minutes
Forced Expiratory Volume, the volume of air that can be forced out in one second after taking a deep breath
FEF25-75%
时间窗: 30 minutes
Forced Expiratory Flow (25-75%), the peak expiratory flow at 25 - 75% FVC
次要结局
未报告次要终点