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OpenTrials
Completed

NCT Number: NCT02805322

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

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

Completed

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Key information

Conditions

Healthy Body Temperature Changes Febrile Fever Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cork University Hospital

Cork, Munster, Ireland

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

ARC InstaTemp MD

Device

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

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.

Primary outcomes

  1. 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.

  2. Reproducibility

    Time frame: Baseline measurement of 3 temperature reading

    Overall reproducibility of ARC InstaTemp™ MD Non-Contact InfraRed Thermometry Device.

Sponsors and collaborators

Lead sponsor

ARC Devices

Industry

Collaborators

  • Cork University Hospital

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 20, 2016
Registry last updated
Jun 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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