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| Name | Class |
|---|---|
| Cork University Hospital | OTHER |
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Quantify the reliability and agreement of estimated core body temperature using the InstaTemp MDâ„¢ and other widely marketed reference Thermometers
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 MDâ„¢ Non-Touch thermometer when compared to other widely marketed reference Thermometers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Temporal Temperature Measurement | Experimental | Infrared Temporal Temperature Measurement using the ARC InstaTemp MD in three different age groups with a specified percentage reporting as febrile. |
|
| Tympanic and/or Sublingual Temperature | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARC InstaTemp MD | Device | Measurement of Body Temperature using an Infrared Non-Touch Thermometer - Experimental arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Bias | Mean Bias (95% Levels of agreement) between ARC InstaTempâ„¢ 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 InstaTempâ„¢ MD Non-Contact InfraRed Thermometry Device. | Baseline measurement of 3 temperature reading |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joe Eustace, Prof | Cork University Hospital, Ireland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cork University Hospital | Cork | Munster | Ireland |
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| Covidien Genius 2 Tympanic Thermometer | Device | Measurement of Tympanic Temperature using a standard approved method - Control arm. |
|
| Welch Allen SureTemp Plus Sublingual Thermometer | Device | Measurement of Sublingual Temperature using a standard approved method - Control arm. |
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| ID | Term |
|---|---|
| D005334 | Fever |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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