Comparison of a Novel Non-Invasive, Non-Touch Infrared Thermometer With Routine Thermometry in Routine Clinical Practice

Study Overview
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Brief Summary
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Quantify the reliability and agreement of estimated core body temperature using the InstaTemp MD™ and other widely marketed reference Thermometers

Detailed Description
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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

Official Title
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Comparison of a Novel Non-Invasive, Non-Touch Infrared Thermometer With Routine Thermometry in Routine Clinical Practice

Conditions
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Healthy, Febrile

Intervention / Treatment
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* Device: ARC InstaTemp MD
* Device: Covidien Genius 2 Tympanic Thermometer
* Device: Welch Allen SureTemp Plus Sublingual Thermometer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any age 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Temporal Temperature Measurement<br>Infrared Temporal Temperature Measurement using the ARC InstaTemp MD in three different age groups with a specified percentage reporting as febrile. | Device: ARC InstaTemp MD<br>* Measurement of Body Temperature using an Infrared Non-Touch Thermometer - Experimental arm.<br>|
| Active Comparator: Tympanic and/or Sublingual Temperature<br>Tympanic and/or Sublingual Temperature Measurement using one or both of two widely used reference clinical thermometers in three different age groups with a specified percentage reporting as febrile. Choice between Tympanic and/or Sublingual is determined based on standard of care in study site Reference Thermometer 1 - Covidien Genius 2 Tympanic Thermometer Reference Thermometer 2 - Welch Allen SureTemp Plus Sublingual Thermometer | Device: Covidien Genius 2 Tympanic Thermometer<br>* Measurement of Tympanic Temperature using a standard approved method - Control arm.<br>Device: Welch Allen SureTemp Plus Sublingual Thermometer<br>* Measurement of Sublingual Temperature using a standard approved method - Control arm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Bias | 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. | Baseline temperature measurement using all relevant interventions | 
| Reproducibility | Overall reproducibility of ARC InstaTemp™ MD Non-Contact InfraRed Thermometry Device. | Baseline measurement of 3 temperature reading |