Clinical trial NCT03147534: Comparison of Thermometry in Canada for Pediatrics
Official title: Comparison of the InstaTemp MD® Infrared Thermometer With Standard Thermometry in Canadian Routine Clinical Practice
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Healthy
Febrile Illness
Lead sponsor: ARC Devices
Sponsor class: INDUSTRY
First posted: 2017-05-10
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 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 outcomes:
measure: 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.
timeFrame: 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.
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Center for Pediatric Excellence
state: Ontario
city: Laval
country: Canada
facility: Agoo Children's Health and Wellness Centre
state: Quebec
Study officials:
affiliation: Center for Pediatric Excellence
name: Judy van Stralen, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References: