Comparison of a Novel Non-Invasive, Non-Touch Infrared Thermometer With Routine Thermometry in Routine Clinical Practice
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|ClinicalTrials.gov Identifier: NCT02805322|
Recruitment Status : Completed
First Posted : June 20, 2016
Last Update Posted : June 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|Healthy Febrile||Device: ARC InstaTemp MD Device: Covidien Genius 2 Tympanic Thermometer Device: Welch Allen SureTemp Plus Sublingual Thermometer||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||138 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of a Novel Non-Invasive, Non-Touch Infrared Thermometer With Routine Thermometry in Routine Clinical Practice|
|Study Start Date :||April 2016|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
Experimental: Temporal Temperature Measurement
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
Measurement of Body Temperature using an Infrared Non-Touch Thermometer - Experimental arm.
Active Comparator: Tympanic and/or Sublingual Temperature
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
Measurement of Tympanic Temperature using a standard approved method - Control arm.
Device: Welch Allen SureTemp Plus Sublingual Thermometer
Measurement of Sublingual Temperature using a standard approved method - Control arm.
- 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.
- Reproducibility [ Time Frame: Baseline measurement of 3 temperature reading ]Overall reproducibility of ARC InstaTemp™ MD Non-Contact InfraRed Thermometry Device.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805322
|Cork University Hospital|
|Cork, Munster, Ireland|
|Principal Investigator:||Joe Eustace, Prof||Cork University Hospital, Ireland|