NCT01927172Unknown不适用
AirSonea Wheeze Detection Study - Multipart Clinical Performance Assessment to Determine Agreement on Wheeze Detection Between AirSonea™ Versus Physician Auscultation and an Expert Panel.
适应症
试验速览
- 阶段
- 不适用
- 发起方
- iSonea
- 入组人数
- 85
- 主要终点
- Device Efficacy
研究概览
简要总结
The purpose of this study is to determine if the AirSonea device provides an objective assessment of breath sounds for the presence of wheeze in both medical and home environments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Part I: Participants presenting to an Acute Care Setting with an exacerbation of asthma or chronic obstructive pulmonary disease symptoms
- •Part II: Volunteer participants without asthma
- •Part III: Participants with asthma
- •For all parts of study
- •Age: 18 years or older
- •Participant has signed an Informed Consent after having the Study explained to them.
排除标准
- •Any medical finding by the physician that would exclude the patient from participating.
- •< than 18 years of age
结局指标
主要结局
Device Efficacy
时间窗: 1 day
Device wheeze detection as compared to physician wheeze detection via auscultation.
次要结局
- Wheeze Rate break points(Up to 1 week)
研究者
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