The Effects of Sex, Body Mass Index, Day-to-Day Subject Variability and Variability of a Single Device When Volume-Averaged Thoracic Bioconductance is Measured With the ProLung Test
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Quantify day-to-day within-subject variability when the same operator uses the same EPN Scanner on the same subjects to measure transcutaneous volume-averaged thoracic bio-conductance on two different days within one week.
研究概览
简要总结
Assess the repeatability of the ProLung Test
详细描述
This repeatability study of the ProLung Test enrolled sixty subjects, 30 male and 30 female, half of each sex with a body mass index (BMI) of 30 or more, and half with a BMI of 28 or less. Each subject was scanned twice on Day One and twice on Day Two. All scans were done by the same operator on the same device. Fifty-nine subjects produced evaluable data. Four models (algorithms) were tested.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 35 to 70 years
- •Able to understand and fulfill all requirements of this protocol
- •Provide signed informed consent
排除标准
- •Pacemaker or other implanted medical device
- •Current life-threatening medical condition
- •Current or recent use of systemic corticosteroids
- •Pregnant or lactating
- •Unusually strenuous exercise within previous 24 hours
- •Current abuse of alcohol or drugs
- •Medical or anatomical condition that precludes testing of all 62 measurement points
- •Other condition or reason at the discretion of the Principal Investigator or medical monitor
结局指标
主要结局
Quantify day-to-day within-subject variability when the same operator uses the same EPN Scanner on the same subjects to measure transcutaneous volume-averaged thoracic bio-conductance on two different days within one week.
时间窗: 1 week
The null hypothesis is that day-to-day variability has no effect on scan results (i.e. when scanned twice on separate days).
Effects of BMI and Sex on transcutaneous volume-averaged thoracic bio-conductance
时间窗: 1 week
The null hypothesis is that BMI has no effect on scan results. The null hypothesis is that sex has no effect on scan results.
Number of participants with device-related adverse events from thoracic bio-conductance measurement.
时间窗: 1 day
time to complete scan.
Quantify EPN Scanner variability in transcutaneous volume-averaged thoracic bio-conductance when measured twice on the same subjects by the same operator on a single same day using the same EPN Scanner
时间窗: 1 day
The null hypothesis is that same-day variability has no effect on scan results (i.e. when scanned twice on the same day).
次要结局
未报告次要终点