NCT06556628进行中（未招募）不适用
Disco Thermometer Engineering Study Protocol
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Clinical Bias
研究概览
简要总结
The goal of this study is to collect febrile, healthy, and in some instances cold temperature data from human subjects ranging from newborns to geriatrics. This data will be used to develop a new thermometer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: normal weight (≥2.5kg), full-term (37 weeks gestation) newborn to geriatric adult.
- •Participant, legal guardian, or healthcare proxy is able to give consent to participate.
- •Participant, legal guardian, or healthcare proxy speaks fluent English.
排除标准
- •The subject does not meet the inclusion criteria.
- •The subject has anatomical abnormalities that would affect temperature.
- •The subject has blood or drainage in the external ear canal.
- •The subject has had something in their ear for a prolonged period, such as a hearing aid or headphones. The subject may be included if the hearing aid or headphones are removed at least 30 minutes prior to taking ear temperature.
- •The subject has been lying on ear within 30 minutes of data collection. The subject may be included if they wait 30 minutes prior to having an ear temperature measurement taken.
- •The subject exhibits symptoms of an acute or chronic inflammatory condition of the external ear canal. An example would be swimmer's ear. The subject may be included if the acute or chronic inflammatory condition is isolated to one ear, then the other ear may be used for data collection.
- •The subject has an ear obstruction or excess cerumen build-up.
- •The subject is in acute distress, i.e., severe pain, severe emotional distress or agitation that would inhibit them from participating in a tympanic ear temperature study.
- •The subject has any known contraindication to oral, ear, or axillary temperature measurements.
- •The subject has used ear drops in the last 8 hours. The subject may be included if the other ear was not medicated with ear drops in the last 8 hours.
- •The subject (age 5+) has consumed food or drink, or smoked, within the last 20 minutes. The subject may be included if they wait 20 minutes prior to taking oral temperature.
- •The subject has taken an antipyretic (ex: Tylenol, Motrin, Aspirin) in the last 120 minutes.
结局指标
主要结局
Clinical Bias
时间窗: Immediately after the diagnostic test
The mean difference between output temperatures of the clinical thermometer under test
次要结局
- Limits of Agreement(Immediately after the diagnostic test)
- Repeatability(Immediately after the diagnostic test)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
Use of Thermography for the Prevention and Diagnosis of Rheumatic FootRheumatic DiseasesRheumatoid Arthritis RARheumatoid ArthritisNCT06515769University of Seville200
已完成
不适用
Efficiency and Efficacy of the Distress Thermometer in the Burn and Wound Population (Research Mentoring High Student Project)BurnsNCT01169285Saint Elizabeth Regional Medical Center
Unknown
不适用
Prizma Device Temperature MeasurementTemperature Change, BodyNCT03340441G Medical Innovations Ltd.300
Unknown
不适用
Temperature Measurement Using a Non Invasive DeviceBody Temperature MeasurementNCT01584401Medisim Ltd500
Unknown
不适用
Continuous Temperature Monitoring for tHe Early Recognition of Febrile Neutropenia in Haematological MALignanciesTemperature Change, BodyMyelomaHaematological MalignancyLymphomaLeukemiaNCT05203809Malaghan Institute of Medical Research20