Clinical Accuracy Study for Infrared Thermometer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 155
- 试验地点
- 1
- 主要终点
- Clinical bias and limits of agreement
研究概览
简要总结
A clinical study will be conducted on the Infrared Thermometers to verify whether its clinical accuracy (clinical bias, limits of agreement, and clinical repeatability) meets the standard requirements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 0-1 year, 1-5 years, or >5 years, regardless of gender;
- •The subject or/and their guardian consents and signs the Informed Consent Form.
排除标准
- •Premature infants with a gestational age of less than 37 weeks and low-birth-weight infants (birth weight less than 2.5kg); this item applies only to subjects aged 0-3 months;
- •Life-threatening acute infections;
- •Subjects who have taken a bath, sponge bath, applied hot/cold compresses, eaten, cried restlessly, or engaged in strenuous exercise within 30 minutes before the trial;
- •Subjects who have taken antipyretics within 180 minutes before the start of the measurement;
- •Other situations deemed inappropriate for participation in this study by the investigator, such as receiving immunization within 7 days before the test.
结局指标
主要结局
Clinical bias and limits of agreement
时间窗: Baseline
Mean difference between OUTPUT TEMPERATURES of a CLINICAL THERMOMETER and a REFERENCE CLINICAL THERMOMETER for the intended REFERENCE BODY SITE with specified LIMITS OF AGREEMENT when measured from selected group of subjects.
Clinical repeatability
时间窗: Baseline
Pooled standard deviation (over a selected group of subjects) of changes in multiple OUTPUT TEMPERATURES taken from the same subject at the same MEASURING SITE with the same CLINICAL THERMOMETER by the same OPERATOR within a relatively short time
次要结局
- Device performance evaluation(Baseline)
- Device defects(Baseline)