Feasibility and Optimization of High Frequency Oscillation (HFO) for Detection of Lung Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Optimal Operating Conditions for HFO Device
研究概览
简要总结
The purpose of this study is to test a lung air vibrator device for vibrating air inside the lung. This exploratory diagnostic trial will test a novel and non-invasive means of detecting lower airway infections using exhaled breath sample.
详细描述
This study has two phases. Once the subject has consented phase 1 will start by the subject breathing air out of their lungs into the device. Next, the subject will simply breathe through the mouthpiece with the machine turned on and take samples of exhaled air.
In phase 2, the subjects will breathe air out of their lungs into the device for 15 minutes. Next, the subject will simply breathe through the mouthpiece with the machine turned on and take samples of exhaled air for 15 minutes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Age 18-50
排除标准
- •History of major respiratory compromise (except cystic fibrosis if included within cystic fibrosis cohort)
结局指标
主要结局
Optimal Operating Conditions for HFO Device
时间窗: 6 months
Following informed consent procedures, participants will be randomly assigned (much like a flip of a coin) to one of four experimental groups in order to test the effects of various frequencies of HFO on the size and concentration of particles obtained from EB. Group 1 (n=30) will receive 10 minutes of HFO at 15 Hz. Group 2 (n=30) will receive an identical course of HFO with the frequency set at 30 Hz. Group 3 (n=30) will receive HFO at 60 Hz and Group 4 (n=30) at 100 Hz. Participants will be tested on two separate days in order to systematically vary HFO intensity. Once again, much like a flip of a coin, each participant will be randomly assigned to receive HFO at either a low (0.75 cmH2O) or high (1.25 cm H2O) intensity on HFO Day 1. Participants receiving low intensity HFO on Day 1 will receive high intensity HFO on Day 2, and vice versa. Between HFO Testing Day 1 and 2 there will be a washout period of at least 24 hours.
次要结局
- Particle size and distribution from exhaled breath(One year)