NCT04144699Unknown不适用
Clinical Validation of Omron WheezeScan
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 240
- 试验地点
- 12
- 主要终点
- Evaluate the sensitivity and specificity of the Omron WheezeScan device
研究概览
简要总结
The WheezeScan sensitivity and specificity are set to statistically prove equal to or higher values than the predicate PulmoTrack device model 2020.
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
- 3 Months 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild to moderate diagnosed or suspected asthma, bronchitis, or bronchiolitis patients who meet all of the following criteria are considered as eligible.
- •Does the subject have mild to moderate diagnosed or suspected asthma, bronchitis, or bronchiolitis?
- •Is the subject between the ages of 3 months to 8 years old?
- •Is the parent or legal guardian available, and capable and willing to give a consent on the child's behalf.
排除标准
- •The subjects will be excluded from the study, if they have any of the following criteria.
- •Does the subject have skin rashes or wounds on the chest?
- •Does the subject have known allergies or irritant contact dermatitis or having hypersensitive skin?
- •Does the subject have a defibrillator and/or pacemaker (which could interfere with the sounds to be detected)?
- •Does the subject have an allergy to disinfecting alcohol?
- •Does the subject have wheezes caused by not asthma, such as reflux esophagitis, pneumonia, vocal cord dysfunction, Tracheomatosis?
- •Does the subject have a heavy runny nose?
- •Is it difficult to hear auscultation due to the subject fussing, crying or vocalizing at data collection?
- •Is the subject having difficulty breathing or having severe symptoms?
- •Was the subject enrolled more than once for the same resulted breath sounds?
- •Note: The subject maybe enrolled once per arm (once wheezing, once non-wheezing).
结局指标
主要结局
Evaluate the sensitivity and specificity of the Omron WheezeScan device
时间窗: Novemver 1, 2019 ~ November 30, 2021
The WheezeScan device will be compared to the gold standard, auscultation, which will be performed by a physician or a qualified healthcare professional with a minimum of 3 years' experience. All breath sounds will be recorded for comparison in case of discrepancy.
次要结局
未报告次要终点
研究者
研究点 (12)
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