Febrile, Healthy
Conditions
Brief summary
Quantify the reliability and agreement of estimated core body temperature using the InstaTemp MD™ and other widely marketed reference Thermometers
Detailed description
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
Interventions
DEVICEARC InstaTemp MD
Measurement of Body Temperature using an Infrared Non-Touch Thermometer - Experimental arm.
DEVICECovidien Genius 2 Tympanic Thermometer
Measurement of Tympanic Temperature using a standard approved method - Control arm.
DEVICEWelch Allen SureTemp Plus Sublingual Thermometer
Measurement of Sublingual Temperature using a standard approved method - Control arm.
Sponsors
Cork University Hospital
ARC Devices
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
1. Any age 2. Either gender 3. Attending ED, outpatients or inpatient Departments of Cork University Hospital Campus 4. Provision of informed consent or in case of minor's provision of age appropriate assent with informed consent of parent (legal guardian).
Exclusion criteria
1. Those who in the opinion of the researcher are too agitated, distressed or who are otherwise unable to cooperate with study procedures 2. Those who forehead cannot be fully exposed to the ambient conditions for at least 15 minutes 3. Those with signs or recent history of inflammation or infection of the forehead or at the Reference Clinical Test site 4. Subjects currently using cooling blankets or fans. 5. Subjects currently receiving treatment with thyroxine, barbiturates, antipsychotics, corticosteroids, alcoholic intoxication, documented illicit drug use or immunizations In the previous 5 days 6. Any recent hot or cold drinks prior to a sub-lingual reading (i.e. 15min before measurement) 7. Those participating in a clinical trial of an investigational medicinal product
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Bias | 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. |
| Reproducibility | Baseline measurement of 3 temperature reading | Overall reproducibility of ARC InstaTemp™ MD Non-Contact InfraRed Thermometry Device. |
Countries
Ireland
Outcome results
None listed