Comparison of Thermometry in Canada for Pediatrics

Healthy Clinical Trial

— CIT-CRCP  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03147534
• Other study ID #: CIT-CRCP-001
• Status: Withdrawn
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: May 8, 2018

Study information

• Verified date: January 2021
• Source: ARC Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 8, 2018
• Est. primary completion date: May 8, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Febrile Illness
• Fever
• Healthy

Intervention

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.
• "Welch Allyn", rectal
The "Welch Allyn" rectal thermometer is intended to measure human body temperature.
• "Welch Allyn", oral
The "Welch Allyn" oral thermometer is intended to measure human body temperature.
• Covidien, tympanic
The Covidien tympanic thermometer is intended to measure human body temperature.

Locations

Country	Name	City	State
Canada	Agoo Children's Health and Wellness Centre	Laval	Quebec
Canada	Center for Pediatric Excellence	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
ARC Devices

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.