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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children Age 1 month to 2 years | Active Comparator | Collecting temperatures on patients using the ARC InstaTemp MD and a "Welch Allyn" rectal thermometer. |
|
| Children > 2 to 5 years | Active Comparator | Collecting temperatures on patients using the ARC InstaTemp MD, the "Welch Allyn" rectal and Covidien tympanic thermometer. |
|
| Children > 5 to ≤ 10 years | Active Comparator | Collecting temperatures on patients using the ARC InstaTemp MD, the "Welch Allyn" oral and the Covidien tympanic thermometer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| InstaTemp MD | Device | 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judy van Stralen, MD FRCPC | Center for Pediatric Excellence | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Pediatric Excellence | Ottawa | Ontario | K2G1W2 | Canada | ||
| Agoo Children's Health and Wellness Centre |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 22, 2017 | Jan 12, 2021 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D000285 | Administration, Rectal |
| ID | Term |
|---|---|
| D058956 | Administration, Mucosal |
| D000287 | Administration, Topical |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
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| "Welch Allyn", rectal | Device | The "Welch Allyn" rectal thermometer is intended to measure human body temperature. |
|
| "Welch Allyn", oral | Device | The "Welch Allyn" oral thermometer is intended to measure human body temperature. |
|
| Covidien, tympanic | Device | The Covidien tympanic thermometer is intended to measure human body temperature. |
|
| Laval |
| Quebec |
| H7P 0H9 |
| Canada |
| D013812 | Therapeutics |