Comparison of Thermometry in Canada for Pediatrics

Study Overview
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Brief Summary
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Compare and assess the accuracy and reliability of the InstaTemp MD® device to techniques presently in use for measuring temperature in infants and children in a Canadian clinical setting.

Detailed Description
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This study is designed as a multi-center study. This study will involve collecting temperatures on patients using the InstaTemp MD® device and the traditional method used in the clinical setting. Reliability and agreement of the InstaTemp MD® will be compared to the current Canadian Paediatric Society's definitely recommended methods of temperature measurement in certain age cohorts of infants and children.

Official Title
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Comparison of the InstaTemp MD® Infrared Thermometer With Standard Thermometry in Canadian Routine Clinical Practice

Conditions
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Healthy, Febrile Illness

Intervention / Treatment
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* Device: InstaTemp MD
* Device: Welch Allyn, rectal
* Device: Welch Allyn, oral
* Device: Covidien, tympanic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children Age 1 month to ≤ 10 years old Male or female Subject's parent or legal guardian over the age of 18 years must sign an informed consent form before any study-related procedures are performed Subjects who in the opinion of the investigator (or as required by the ethics committee) have the capacity to understand and sign an assent form, must provide written assent Exclusion Criteria: Subjects who in the opinion of the researcher are too agitated, distressed or who are otherwise unable to cooperate with study procedures Subjects whose forehead cannot be fully exposed to the ambient condidtions for at least 15 minutes. Subjects 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 with tubes in their ear(s) cannot participate in the tympanic comparison, but this is not exclusionary for InstaTemp MD and definitive comparator (e.g. rectal or oral) measurements. Subjects currently receiving treatment with thyroxine, barbiturates, antipsychotics, cortico-steroids (oral iv, or topically applied to forehead) Subjects currently alcohol intoxicated Subjects with documented illicit durg use in the previous 5 days Subjects that have had any hot or cold drinks within 15 minutes prior to a sublingual reading Subject is taking any medication that in the opinion of the investigator may alter the temperature of the child Subjects participating in a clinical trial of an investigational medicinal product within the last 30 days.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 10 Years

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Children Age 1 month to 2 years<br>Collecting temperatures on patients using the ARC InstaTemp MD and a Welch Allyn rectal thermometer. | Device: InstaTemp MD<br>* The InstaTemp MD is a hand held electronic infrared thermometer that is intended to accurately measure human body temperature without contact with the human body.<br>Device: Welch Allyn, rectal<br>* The Welch Allyn rectal thermometer is intended to measure human body temperature.<br>|
| Active Comparator: Children > 2 to 5 years<br>Collecting temperatures on patients using the ARC InstaTemp MD, the Welch Allyn rectal and Covidien tympanic thermometer. | Device: InstaTemp MD<br>* The InstaTemp MD is a hand held electronic infrared thermometer that is intended to accurately measure human body temperature without contact with the human body.<br>Device: Welch Allyn, rectal<br>* The Welch Allyn rectal thermometer is intended to measure human body temperature.<br>Device: Covidien, tympanic<br>* The Covidien tympanic thermometer is intended to measure human body temperature.<br>|
| Active Comparator: Children > 5 to ≤ 10 years<br>Collecting temperatures on patients using the ARC InstaTemp MD, the Welch Allyn oral and the Covidien tympanic thermometer. | Device: InstaTemp MD<br>* The InstaTemp MD is a hand held electronic infrared thermometer that is intended to accurately measure human body temperature without contact with the human body.<br>Device: Welch Allyn, oral<br>* The Welch Allyn oral thermometer is intended to measure human body temperature.<br>Device: Covidien, tympanic<br>* The Covidien tympanic thermometer is intended to measure human body temperature.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Temperature measurements using Welch Allyn (oral/rectal), Covidien (tympanic) and ARC InstaTempMD (non-touch, infrared) in degrees Celcius and will be compared with three consecutive measurements with each thermometer. | Compare the compendia thermometers in each age range to the InstaTemp MD to determine average clinical bias. | Participant will only be required to attend one visit which will last up to a maximum of 30 minutes for the duration of the study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Comparison Analysis. Temperature measurements using Welch Allyn (oral/recta.), Covidien (tympanic) and ARC InstaTemp MD (non-touch, infrared) in degrees Celcius and will be compared with three consecutive measurements with each thermometer. | To determine the precision of the InstaTemp MD compared to the compendia thermometers based on three consecutive measurements with each thermometer. | Participant will only be required to attend one visit which will last up to a maximum of 30 minutes for the duration of the study. |