Evaluation of the Tyto Thermometer When Used in Clinical Care Setting
试验速览
- 阶段
- 不适用
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Body temperature measurement
研究概览
简要总结
Patients who present to the Emergency Department will be evaluated for eligibility to the study. Those meeting all the inclusion criteria and none of the exclusion criteria will undergo an informed consent process and will sign a written consent. Within each age group both afebrile and febrile patients will be represented.
The patients will be divided into 3 study groups by age:
Group 1: up to 1 year Group 2: 1 to 5 years Group 3: older than 5 years
The following temperature measurements will be taken:
- Three temperature measurements using the Tyto thermometer
- Temperature measurement using the standard of care
- Three temperature measurements using the predicate device
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Male or female, of any age
- •Subject or Parent/Guardian: able to communicate with study personnel;
- •Subject or Parent/Guardian: able to understand the nature of the study and provide written informed consent
- •Subject or Parent/Guardian willing to comply with study procedures
排除标准
- •Cognitive impairment, history of dementia, psychiatric disorders, mental disorders or PDD.
- •Subject or legal guardian unwilling to sign informed consent form
- •Those with signs or recent history of inflammation or infection of the forehead or at the Reference Clinical Test site (site of temperature measurement in any one of the devices used).
- •Subjects currently using cooling blankets, ice on their forehead or fans.
- •Subjects receiving treatment with antipyretics, barbiturates, antipsychotics for the past 3 hours.
- •Subjects receiving current systemic treatment with thyroid preparations, corticosteroids or underwent immunizations during the past 7 days.
- •Subjects with documented illicit drug use or alcoholic intoxication
- •Those participating in a clinical trial of an investigational medicinal product
- •Carriers of multi drug resistant bacteria
- •CTAS score of 1-2
研究组 & 干预措施
Tyto Thermometer, SoC Thermometer, Predicate IR Th
All the study participants undergo temperature measurements with:
- Tyto Thermometer
- Standard of Care thermometer
- Predicate IR thermometer
干预措施: Temperature measurementsusing the Tyto thermometer, the standard of care thermometer and the predicate thermometer (Device)
结局指标
主要结局
Body temperature measurement
时间窗: a period of no more than 12 minutes
次要结局
未报告次要终点