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

Phase 4

Completed

• Conditions: Febrile; Healthy
• Interventions: Device: Covidien Genius 2 Tympanic Thermometer; Device: ARC InstaTemp MD; Device: Welch Allen SureTemp Plus Sublingual Thermometer

• Registration Number: NCT02805322
• Lead Sponsor: ARC Devices

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2016-04
• Status Verified: 2016-06
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Study First Submitted: 2016-06-09
• Study First Submitted QC: 2016-06-15
• Last Update Submitted: 2016-06-15
• Study First Posted: 2016-06-20
• Last Update Posted: 2016-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

1. Any age
2. Either gender
3. Attending ED, outpatients or inpatient Departments of Cork University Hospital Campus
4. Provision of informed consent or in case of minor's provision of age appropriate assent with informed consent of parent (legal guardian).

Exclusion Criteria

1. Those who in the opinion of the researcher are too agitated, distressed or who are otherwise unable to cooperate with study procedures
2. Those who forehead cannot be fully exposed to the ambient conditions for at least 15 minutes
3. Those with signs or recent history of inflammation or infection of the forehead or at the Reference Clinical Test site
4. Subjects currently using cooling blankets or fans.
5. Subjects currently receiving treatment with thyroxine, barbiturates, antipsychotics, corticosteroids, alcoholic intoxication, documented illicit drug use or immunizations In the previous 5 days
6. Any recent hot or cold drinks prior to a sub-lingual reading (i.e. 15min before measurement)
7. Those participating in a clinical trial of an investigational medicinal product

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tympanic and/or Sublingual Temperature	Covidien Genius 2 Tympanic Thermometer	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
Temporal Temperature Measurement	ARC InstaTemp MD	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	Welch Allen SureTemp Plus Sublingual Thermometer	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

Primary Outcome Measures

Name	Time	Method
Reproducibility	Baseline measurement of 3 temperature reading	Overall reproducibility of ARC InstaTemp™ MD Non-Contact InfraRed Thermometry Device.
Mean Bias	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.

Trial Locations

Locations (1)

Cork University Hospital; 🇮🇪 Cork, Munster, Ireland