HealthyCIT-CRCPNCT03147534
Comparison of Thermometry in Canada for Pediatrics
A study testing InstaTemp MD, "Welch Allyn", rectal and "Welch Allyn", oral in people with Healthy and Febrile Illness, run by ARC Devices at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 1 month to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Febrile Illness
- What is being tested?
- InstaTemp MD, "Welch Allyn", rectal and "Welch Allyn", oral
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Feb 2017to 8 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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 locations and contacts
2 sites in 1 country.
Canada2 sites
Agoo Children's Health and Wellness Centre
Laval, Quebec, H7P 0H9
Center for Pediatric Excellence
Ottawa, Ontario, K2G1W2
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy, Febrile Illness
- Being tested
- InstaTemp MD, "Welch Allyn", rectal, "Welch Allyn", oral, Covidien, tympanic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InstaTemp MDDevice
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", rectalDevice
The "Welch Allyn" rectal thermometer is intended to measure human body temperature.
"Welch Allyn", oralDevice
The "Welch Allyn" oral thermometer is intended to measure human body temperature.
Covidien, tympanicDevice
The Covidien tympanic thermometer is intended to measure human body temperature.
| Study group | Role | What they receive |
|---|---|---|
| Children Age 1 month to 2 years | Active comparator | Collecting temperatures on patients using the ARC InstaTemp MD and a "Welch Allyn" rectal thermometer. Receives: Device: InstaTemp MD; Device: "Welch Allyn", rectal |
| Children > 2 to 5 years | Active comparator | Collecting temperatures on patients using the ARC InstaTemp MD, the "Welch Allyn" rectal and Covidien tympanic thermometer. Receives: Device: InstaTemp MD; Device: "Welch Allyn", rectal; Device: Covidien, tympanic |
| Children > 5 to ≤ 10 years | Active comparator | Collecting temperatures on patients using the ARC InstaTemp MD, the "Welch Allyn" oral and the Covidien tympanic thermometer. Receives: Device: InstaTemp MD; Device: "Welch Allyn", oral; Device: Covidien, tympanic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (1)
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start1 Feb 2017
- Primary completion8 May 2018
- Study completion8 May 2018
Why it stopped: Not able to recruit patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARC Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Judy van Stralen, MD FRCPC, Principal investigator, Center for Pediatric Excellence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03147534
- Sponsor's protocol ID
- CIT-CRCP-001
- Acronym
- CIT-CRCP
- Status last verified
- Jan 2021
- First submitted
- 19 Apr 2017
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the InstaTemp MD® Infrared Thermometer With Standard Thermometry in Canadian Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT03147534
- Acronym / sponsor ID
- CIT-CRCP / CIT-CRCP-001
- Conditions
- Healthy, Febrile Illness
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not able to recruit patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ARC DevicesIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 8 May 2018 (actual)
- Study completion
- 8 May 2018 (actual)
- First posted
- 10 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Children Age 1 month to 2 years | Active comparator | Device: InstaTemp MD, Device: "Welch Allyn", rectalCollecting temperatures on patients using the ARC InstaTemp MD and a "Welch Allyn" rectal thermometer. |
| Children > 2 to 5 years | Active comparator | Device: InstaTemp MD, Device: "Welch Allyn", rectal, Device: Covidien, tympanicCollecting temperatures on patients using the ARC InstaTemp MD, the "Welch Allyn" rectal and Covidien tympanic thermometer. |
| Children > 5 to ≤ 10 years | Active comparator | Device: InstaTemp MD, Device: "Welch Allyn", oral, Device: Covidien, tympanicCollecting temperatures on patients using the ARC InstaTemp MD, the "Welch Allyn" oral and the Covidien tympanic thermometer. |
Who may qualify
- Ages
- 1 month to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InstaTemp MDThe 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 | Children > 2 to 5 years, Children > 5 to ≤ 10 years, Children Age 1 month to 2 years |
| "Welch Allyn", rectalThe "Welch Allyn" rectal thermometer is intended to measure human body temperature. | Device | Children > 2 to 5 years, Children Age 1 month to 2 years |
| "Welch Allyn", oralThe "Welch Allyn" oral thermometer is intended to measure human body temperature. | Device | Children > 5 to ≤ 10 years |
| Covidien, tympanicThe Covidien tympanic thermometer is intended to measure human body temperature. | Device | Children > 2 to 5 years, Children > 5 to ≤ 10 years |
Primary outcome
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.
Time frame: 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.
1 secondary outcome
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.
Time frame: 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judy van Stralen, MD FRCPC principal investigator
Center for Pediatric Excellence
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InstaTemp MD, "Welch Allyn", rectal and "Welch Allyn", oral in people with Healthy and Febrile Illness, run by ARC Devices at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2021.