Comparison of a Novel Non-Invasive, Non-Touch Infrared Thermometer With Routine Thermometry in Routine Clinical Practice
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- ARC Devices
- Enrollment
- 138
- Locations
- 1
- Primary Endpoint
- Reproducibility
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •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).
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Reproducibility
Time Frame: Baseline measurement of 3 temperature reading
Overall reproducibility of ARC InstaTemp™ MD Non-Contact InfraRed Thermometry Device.
Mean Bias
Time Frame: 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.