Comparison of the InstaTemp MD® Infrared Thermometer With Standard Thermometry in Canadian Routine Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 4
- 主要终点
- Temperature measurements using "Welch Allyn" (oral/rectal), Covidien (tympanic) and ARC InstaTempMD (non-touch, infrared) in degrees Celcius and will be compared with three consecutive measurements with each thermometer.
研究概览
简要总结
Compare and assess the accuracy and reliability of the InstaTemp MD® device to techniques presently in use for measuring temperature in infants and children in a Canadian clinical setting.
详细描述
This study is designed as a multi-center study. This study will involve collecting temperatures on patients using the InstaTemp MD® device and the traditional method used in the clinical setting. Reliability and agreement of the InstaTemp MD® will be compared to the current Canadian Paediatric Society's definitely recommended methods of temperature measurement in certain age cohorts of infants and children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children Age 1 month to ≤ 10 years old
- •Male or female
- •Subject's parent or legal guardian over the age of 18 years must sign an informed consent form before any study-related procedures are performed
- •Subjects who in the opinion of the investigator (or as required by the ethics committee) have the capacity to understand and sign an assent form, must provide written assent
排除标准
- •Subjects who in the opinion of the researcher are too agitated, distressed or who are otherwise unable to cooperate with study procedures
- •Subjects whose forehead cannot be fully exposed to the ambient condidtions for at least 15 minutes.
- •Subjects 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 with tubes in their ear(s) cannot participate in the tympanic comparison, but this is not exclusionary for InstaTemp MD and definitive comparator (e.g. rectal or oral) measurements.
- •Subjects currently receiving treatment with thyroxine, barbiturates, antipsychotics, cortico-steroids (oral iv, or topically applied to forehead)
- •Subjects currently alcohol intoxicated
- •Subjects with documented illicit durg use in the previous 5 days
- •Subjects that have had any hot or cold drinks within 15 minutes prior to a sublingual reading
- •Subject is taking any medication that in the opinion of the investigator may alter the temperature of the child
- •Subjects participating in a clinical trial of an investigational medicinal product within the last 30 days.
结局指标
主要结局
Temperature measurements using "Welch Allyn" (oral/rectal), Covidien (tympanic) and ARC InstaTempMD (non-touch, infrared) in degrees Celcius and will be compared with three consecutive measurements with each thermometer.
时间窗: Participant will only be required to attend one visit which will last up to a maximum of 30 minutes for the duration of the study.
Compare the compendia thermometers in each age range to the InstaTemp MD to determine average clinical bias.
次要结局
- Mean Comparison Analysis. Temperature measurements using "Welch Allyn" (oral/recta.), Covidien (tympanic) and ARC InstaTemp MD (non-touch, infrared) in degrees Celcius and will be compared with three consecutive measurements with each thermometer.(Participant will only be required to attend one visit which will last up to a maximum of 30 minutes for the duration of the study.)