Comparison of Thermometry in Canada for Pediatrics (CIT-CRCP)

Comparison of the InstaTemp MD® Infrared Thermometer With Standard Thermometry in Canadian Routine Clinical Practice

Compare and assess the accuracy and reliability of the InstaTemp MD® device to techniques presently in use for measuring temperature in infants and children in a Canadian clinical setting.

Study Overview

• Status: Withdrawn
• Conditions: Healthy; Febrile Illness
• Intervention / Treatment: Device: InstaTemp MD; Device: "Welch Allyn", rectal; Device: Covidien, tympanic; Device: "Welch Allyn", oral

Detailed Description

This study is designed as a multi-center study. This study will involve collecting temperatures on patients using the InstaTemp MD® device and the traditional method used in the clinical setting. Reliability and agreement of the InstaTemp MD® will be compared to the current Canadian Paediatric Society's definitely recommended methods of temperature measurement in certain age cohorts of infants and children.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K2G1W2
      • Center for Pediatric Excellence
  • Quebec
    • Laval, Quebec, Canada, H7P 0H9
      • Agoo Children's Health and Wellness Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 10 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children Age 1 month to ≤ 10 years old
• Male or female
• Subject's parent or legal guardian over the age of 18 years must sign an informed consent form before any study-related procedures are performed
• Subjects who in the opinion of the investigator (or as required by the ethics committee) have the capacity to understand and sign an assent form, must provide written assent

Exclusion Criteria:

• Subjects who in the opinion of the researcher are too agitated, distressed or who are otherwise unable to cooperate with study procedures
• Subjects whose forehead cannot be fully exposed to the ambient condidtions for at least 15 minutes.
• Subjects 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 with tubes in their ear(s) cannot participate in the tympanic comparison, but this is not exclusionary for InstaTemp MD and definitive comparator (e.g. rectal or oral) measurements.
• Subjects currently receiving treatment with thyroxine, barbiturates, antipsychotics, cortico-steroids (oral iv, or topically applied to forehead)
• Subjects currently alcohol intoxicated
• Subjects with documented illicit durg use in the previous 5 days
• Subjects that have had any hot or cold drinks within 15 minutes prior to a sublingual reading
• Subject is taking any medication that in the opinion of the investigator may alter the temperature of the child
• Subjects participating in a clinical trial of an investigational medicinal product within the last 30 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Children Age 1 month to 2 years; Collecting temperatures on patients using the ARC InstaTemp MD and a "Welch Allyn" rectal thermometer.	Device: InstaTemp MD; The InstaTemp MD is a hand held electronic infrared thermometer that is intended to accurately measure human body temperature without contact with the human body.; Device: "Welch Allyn", rectal; The "Welch Allyn" rectal thermometer is intended to measure human body temperature.
ACTIVE_COMPARATOR: Children > 2 to 5 years; Collecting temperatures on patients using the ARC InstaTemp MD, the "Welch Allyn" rectal and Covidien tympanic thermometer.	Device: InstaTemp MD; The InstaTemp MD is a hand held electronic infrared thermometer that is intended to accurately measure human body temperature without contact with the human body.; Device: "Welch Allyn", rectal; The "Welch Allyn" rectal thermometer is intended to measure human body temperature.; Device: Covidien, tympanic; The Covidien tympanic thermometer is intended to measure human body temperature.
ACTIVE_COMPARATOR: Children > 5 to ≤ 10 years; Collecting temperatures on patients using the ARC InstaTemp MD, the "Welch Allyn" oral and the Covidien tympanic thermometer.	Device: InstaTemp MD; The InstaTemp MD is a hand held electronic infrared thermometer that is intended to accurately measure human body temperature without contact with the human body.; Device: Covidien, tympanic; The Covidien tympanic thermometer is intended to measure human body temperature.; Device: "Welch Allyn", oral; The "Welch Allyn" oral thermometer is intended to measure human body temperature.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Temperature measurements using "Welch Allyn" (oral/rectal), Covidien (tympanic) and ARC InstaTempMD (non-touch, infrared) in degrees Celcius and will be compared with three consecutive measurements with each thermometer.	Compare the compendia thermometers in each age range to the InstaTemp MD to determine average clinical bias.	Participant will only be required to attend one visit which will last up to a maximum of 30 minutes for the duration of the study.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Comparison Analysis. Temperature measurements using "Welch Allyn" (oral/recta.), Covidien (tympanic) and ARC InstaTemp MD (non-touch, infrared) in degrees Celcius and will be compared with three consecutive measurements with each thermometer.	To determine the precision of the InstaTemp MD compared to the compendia thermometers based on three consecutive measurements with each thermometer.	Participant will only be required to attend one visit which will last up to a maximum of 30 minutes for the duration of the study.

Collaborators and Investigators

• Sponsor: ARC Devices
• Investigators: Principal Investigator: Judy van Stralen, MD FRCPC, Center for Pediatric Excellence

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2017
• Primary Completion (ACTUAL): May 8, 2018
• Study Completion (ACTUAL): May 8, 2018

Study Registration Dates

• First Submitted: April 19, 2017
• First Submitted That Met QC Criteria: May 8, 2017
• First Posted (ACTUAL): May 10, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 14, 2021
• Last Update Submitted That Met QC Criteria: January 12, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Body Temperature Changes; Heat Stress Disorders; Hyperthermia; Fever
• Other Study ID Numbers: CIT-CRCP-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes