Clinical Performance of Masimo INVSENSOR00048
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Clinical Performance of Masimo INVSENSOR00048
研究概览
简要总结
The objective of this clinical study is to validate temperature performance of the noninvasive Masimo INVSENSOR00048.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Afebrile subjects of all ages, or febrile subjects of all ages who meet the following criteria for screening temperature:
- •sublingual temperature ≥ 37.5°C (99.5°F),
- •rectal temperature ≥ 38.0°C (100.4°F),
- •or axillary temperature ≥ 37.2°C (99.0°F)
- •If subject is < 18 years old, parents or legally authorized representatives (LAR) have provided informed consent and have signed all necessary related documents
排除标准
- •Subjects with medical conditions such as inflammation at the measuring site or taking medications e.g. barbiturates, thyroid preparations, antipsychotics, or immunization within prior 7 days, which might skew clinical accuracy validation results such as, per the investigator's judgement
- •Subjects unable to provide informed consent or assent, as appropriate
- •Subjects with conditions at or around site of sensor placement or skin abnormalities affecting the sensor placement area such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown that would prevent monitoring of physiological parameters during the study
- •Subjects with known allergies to adhesive material used in medical equipment
- •Subjects with medical conditions which, in the judgment of the investigator, renders them inappropriate for participation in this study
- •Excluded at the Principal Investigator's discretion
结局指标
主要结局
Clinical Performance of Masimo INVSENSOR00048
时间窗: Approximately 90 minutes
The outcome measure is determination of the Masimo INVSENSOR00048 temperature performance by comparing the Clinical Bias and Limits of Agreement (LOA) between the corresponding adjustment mode temperature of the INVSENSOR00048 and reference thermometer in degrees celsius. Clincal Bias is defined as mean difference between output temperatires of a clinical thermometer and a reference clinical thermometer for the intended reference body site with specified limitis of agreement when measured from selected group of subjects . Limits of agreement is defined as the magnitude of a potential disagreement between outputs of two clinical thermometers equal to double the standard deviation of output temperate differences when used on the same human subject .
次要结局
未报告次要终点