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

ARC Devices

Status: Withdrawn

Conditions: Healthy; Febrile Illness

Treatments: Device: Covidien, tympanic; Device: "Welch Allyn", rectal; Device: InstaTemp MD; Device: "Welch Allyn", oral

Study type: Interventional

Funder types: Industry

Identifiers

NCT03147534

CIT-CRCP-001

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 1 month to 10 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Children Age 1 month to 2 years

Active Comparator group

Description:

Collecting temperatures on patients using the ARC InstaTemp MD and a "Welch Allyn" rectal thermometer.

Treatment:

Device: "Welch Allyn", rectal

Device: InstaTemp MD

Children > 2 to 5 years

Active Comparator group

Description:

Collecting temperatures on patients using the ARC InstaTemp MD, the "Welch Allyn" rectal and Covidien tympanic thermometer.

Treatment:

Device: Covidien, tympanic

Device: "Welch Allyn", rectal

Device: InstaTemp MD

Children > 5 to ≤ 10 years

Active Comparator group

Description:

Collecting temperatures on patients using the ARC InstaTemp MD, the "Welch Allyn" oral and the Covidien tympanic thermometer.

Treatment:

Device: Covidien, tympanic

Device: "Welch Allyn", oral

Device: InstaTemp MD