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

ARC Devices

Status and phase: Completed; Phase 4

Conditions: Healthy; Febrile

Treatments: Device: Covidien Genius 2 Tympanic Thermometer; Device: ARC InstaTemp MD; Device: Welch Allen SureTemp Plus Sublingual Thermometer

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02805322

ARC-CRFC-03

Details and patient eligibility

About

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

Full 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

Enrollment: 138 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

138 participants in 2 patient groups

Temporal Temperature Measurement

Experimental group

Description:

Infrared Temporal Temperature Measurement using the ARC InstaTemp MD in three different age groups with a specified percentage reporting as febrile.

Treatment:

Device: ARC InstaTemp MD

Tympanic and/or Sublingual Temperature

Active Comparator group

Description:

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

Treatment:

Device: Welch Allen SureTemp Plus Sublingual Thermometer

Device: Covidien Genius 2 Tympanic Thermometer