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

NCT02805322 | Completed Phase 4

• 1 other identifier: ARC-CRFC-03
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy; Febrile

Outcome Measures

Primary Outcomes (2)

• Mean Bias

  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

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

  Baseline measurement of 3 temperature reading

Study Arms (2)

Temporal Temperature Measurement

EXPERIMENTAL

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

Tympanic and/or Sublingual Temperature

ACTIVE COMPARATOR

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; Device: Welch Allen SureTemp Plus Sublingual Thermometer

Interventions

ARC InstaTemp MD DEVICE

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

Temporal Temperature Measurement

Covidien Genius 2 Tympanic Thermometer DEVICE

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

Tympanic and/or Sublingual Temperature

Welch Allen SureTemp Plus Sublingual Thermometer DEVICE

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

Tympanic and/or Sublingual Temperature

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• ARC Devices: lead
• Cork University Hospital: collaborator

Study Sites (1)

Cork University Hospital

Cork, Munster, Ireland

Location

MeSH Terms

Conditions

Fever

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joe Eustace, Prof

  Cork University Hospital, Ireland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: June 20, 2016
• Study Start: April 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 20, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)