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

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ClinicalTrials.gov Identifier: NCT02805322
Recruitment Status : Completed
First Posted : June 20, 2016
Last Update Posted : June 20, 2016
Sponsor:
Collaborator:
Cork University Hospital
Information provided by (Responsible Party):
ARC Devices

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

Condition or disease Intervention/treatment Phase
Healthy Febrile Device: ARC InstaTemp MD Device: Covidien Genius 2 Tympanic Thermometer Device: Welch Allen SureTemp Plus Sublingual Thermometer Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Comparison of a Novel Non-Invasive, Non-Touch Infrared Thermometer With Routine Thermometry in Routine Clinical Practice
Study Start Date : April 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

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.




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805322


Locations
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Ireland
Cork University Hospital
Cork, Munster, Ireland
Sponsors and Collaborators
ARC Devices
Cork University Hospital
Investigators
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Principal Investigator: Joe Eustace, Prof Cork University Hospital, Ireland
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Responsible Party: ARC Devices
ClinicalTrials.gov Identifier: NCT02805322    
Other Study ID Numbers: ARC-CRFC-03
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: June 20, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Fever
Body Temperature Changes