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

June 15, 2016 updated by: ARC Devices
Quantify the reliability and agreement of estimated core body temperature using the InstaTemp MD™ and other widely marketed reference Thermometers

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

138

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
    • Munster
      • Cork, Munster, Ireland
        • Cork University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline temperature measurement using all relevant interventions
Reproducibility
Time Frame: Baseline measurement of 3 temperature reading
Overall reproducibility of ARC InstaTemp™ MD Non-Contact InfraRed Thermometry Device.
Baseline measurement of 3 temperature reading

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ARC Devices

Collaborators

Cork University Hospital

Investigators

  • Principal Investigator: Joe Eustace, Prof, Cork University Hospital, Ireland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

June 9, 2016

First Submitted That Met QC Criteria

June 15, 2016

First Posted (Estimate)

June 20, 2016

Study Record Updates

Last Update Posted (Estimate)

June 20, 2016

Last Update Submitted That Met QC Criteria

June 15, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARC-CRFC-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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