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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-06-30

Brief Summary

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

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Detailed Description

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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

Conditions

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Healthy Febrile

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Temporal Temperature Measurement

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

Group Type EXPERIMENTAL

ARC InstaTemp MD

Intervention Type DEVICE

Measurement of Body Temperature using an Infrared Non-Touch Thermometer - Experimental arm.

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

Group Type ACTIVE_COMPARATOR

Covidien Genius 2 Tympanic Thermometer

Intervention Type DEVICE

Measurement of Tympanic Temperature using a standard approved method - Control arm.

Welch Allen SureTemp Plus Sublingual Thermometer

Intervention Type DEVICE

Measurement of Sublingual Temperature using a standard approved method - Control arm.

Interventions

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ARC InstaTemp MD

Measurement of Body Temperature using an Infrared Non-Touch Thermometer - Experimental arm.

Intervention Type DEVICE

Covidien Genius 2 Tympanic Thermometer

Measurement of Tympanic Temperature using a standard approved method - Control arm.

Intervention Type DEVICE

Welch Allen SureTemp Plus Sublingual Thermometer

Measurement of Sublingual Temperature using a standard approved method - Control arm.

Intervention Type DEVICE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes