Comparison of a Novel Non-Invasive, Non-Touch Infrared Thermometer With Routine Thermometry in Routine Clinical Practice
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Reproducibility
研究概览
简要总结
Quantify the reliability and agreement of estimated core body temperature using the InstaTemp MD™ and other widely marketed reference Thermometers
详细描述
This is a cross sectional Clinical Investigation in order to quantify the reliability and agreement of estimated core body temperature using emitted surface body heat measured by the InstaTemp MD™ Non-Touch thermometer when compared to other widely marketed reference Thermometers
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Either gender
- •Attending ED, outpatients or inpatient Departments of Cork University Hospital Campus
- •Provision of informed consent or in case of minor's provision of age appropriate assent with informed consent of parent (legal guardian).
排除标准
- •Those who in the opinion of the researcher are too agitated, distressed or who are otherwise unable to cooperate with study procedures
- •Those who forehead cannot be fully exposed to the ambient conditions for at least 15 minutes
- •Those with signs or recent history of inflammation or infection of the forehead or at the Reference Clinical Test site
- •Subjects currently using cooling blankets or fans.
- •Subjects currently receiving treatment with thyroxine, barbiturates, antipsychotics, corticosteroids, alcoholic intoxication, documented illicit drug use or immunizations In the previous 5 days
- •Any recent hot or cold drinks prior to a sub-lingual reading (i.e. 15min before measurement)
- •Those participating in a clinical trial of an investigational medicinal product
结局指标
主要结局
Reproducibility
时间窗: Baseline measurement of 3 temperature reading
Overall reproducibility of ARC InstaTemp™ MD Non-Contact InfraRed Thermometry Device.
Mean Bias
时间窗: Baseline temperature measurement using all relevant interventions
Mean Bias (95% Levels of agreement) between ARC InstaTemp™ MD Non-Contact InfraRed Thermometry Device and (a) the Covidien Tympanic thermometer and (b) the Welch Allyn thermometer at an oral or axillary site as appropriate to subjects' age and clinical circumstance.
次要结局
未报告次要终点