Clinical Performance of Masimo INVSENSOR00048
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Primary Outcome
研究概览
简要总结
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
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Febrile subjects aged 18 years and older who meet the following criteria for screening temperature:
- •sublingual temperature ≥ 37.5°C (99.5°F),
- •or axillary temperature ≥ 37.2°C (99.0°F)
排除标准
- •Subjects with medical conditions such as inflammation at the measuring site or taking medications which might skew clinical accuracy validation results (e.g. barbiturates, thyroid preparations, antipsychotics or immunization within prior 7 days) or per the investigator's judgement
- •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
研究组 & 干预措施
INVSENSOR00048
All subjects are enrolled into the test group and are fitted with the non-invasive investigational sensor for body temperature measurements
干预措施: INVSENSOR00048 (Device)
结局指标
主要结局
Primary Outcome
时间窗: Approximately 90 minutes
The 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 device under test (DUT) and reference thermometer. 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