Comparison of Thermometry in Canada for Pediatrics

Not Applicable

Withdrawn

• Conditions: Febrile Illness; Healthy
• Interventions: Device: InstaTemp MD; Device: "Welch Allyn", rectal; Device: "Welch Allyn", oral; Device: Covidien, tympanic

• Registration Number: NCT03147534
• Lead Sponsor: ARC Devices

Brief Summary

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.

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 Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2017-04-19
• Study First Submitted QC: 2017-05-08
• Study First Posted: 2017-05-10
• Primary Completion: 2018-05-08
• Study Completion: 2018-05-08
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-12
• Last Update Posted: 2021-01-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Children Age 1 month to 2 years	"Welch Allyn", rectal	Collecting temperatures on patients using the ARC InstaTemp MD and a "Welch Allyn" rectal thermometer.
Children > 5 to ≤ 10 years	Covidien, tympanic	Collecting temperatures on patients using the ARC InstaTemp MD, the "Welch Allyn" oral and the Covidien tympanic thermometer.
Children > 2 to 5 years	InstaTemp MD	Collecting temperatures on patients using the ARC InstaTemp MD, the "Welch Allyn" rectal and Covidien tympanic thermometer.
Children > 2 to 5 years	"Welch Allyn", rectal	Collecting temperatures on patients using the ARC InstaTemp MD, the "Welch Allyn" rectal and Covidien tympanic thermometer.
Children > 5 to ≤ 10 years	InstaTemp MD	Collecting temperatures on patients using the ARC InstaTemp MD, the "Welch Allyn" oral and the Covidien tympanic thermometer.
Children > 5 to ≤ 10 years	"Welch Allyn", oral	Collecting temperatures on patients using the ARC InstaTemp MD, the "Welch Allyn" oral and the Covidien tympanic thermometer.
Children Age 1 month to 2 years	InstaTemp MD	Collecting temperatures on patients using the ARC InstaTemp MD and a "Welch Allyn" rectal thermometer.
Children > 2 to 5 years	Covidien, tympanic	Collecting temperatures on patients using the ARC InstaTemp MD, the "Welch Allyn" rectal and Covidien tympanic thermometer.

Primary Outcome Measures

Name	Time	Method
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.	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.	Compare the compendia thermometers in each age range to the InstaTemp MD to determine average clinical bias.

Secondary Outcome Measures

Name	Time	Method
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.	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.	To determine the precision of the InstaTemp MD compared to the compendia thermometers based on three consecutive measurements with each thermometer.

Trial Locations

Locations (2)

Agoo Children's Health and Wellness Centre; 🇨🇦 Laval, Quebec, Canada

Center for Pediatric Excellence; 🇨🇦 Ottawa, Ontario, Canada