FeverNCT05674344

Calibration and Validation of the Masimo Temperature Device in Febrile Patients

A study testing Masimo Temperature device in people with Fever, run by Masimo Corporation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The goal of this clinical trial is to test the performance of the Masimo noninvasive temperature device in patients with fever. The main question it aims to answer is whether the Masimo temperature device is comparable to standard methods of taking temperature such as inserting a probe under the tongue or using a… Read more about this study

Who is it for?: Ages 1 year and older
Conditions the study is for: Fever
What is being tested?: Masimo Temperature device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 170 participants
Where: 1 siteUnited States
Study dates: 1 Dec 2022to 2 Mar 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 year and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Patients age ≥ 1year old
Febrile at time of enrollment: ≥ 99.5oF/37.5oC for patients ages 1-5 years; ≥ 100.4oF/38oC for patients older than 5 years old.
English- or Spanish-speaking patient or parent/LAR

Who cannot join

Patients deemed not suitable for the study at the discretion of the investigator
Patients who are rated as a 1 or 2 Emergency Severity Index

Trial locations and contacts

1 site in 1 country.

United States1 site

Site 1
Orange, California, 92630

Other trials in United States

About this study

Official title: Calibration and Validation of the Masimo Rad-G With Temperature Device in Febrile Patients

Participants will be asked to sit still while rounds of measurements are taken using the Masimo temperature device and the reference temperature device. Researchers will compare the measurements taken with the Masimo device with the measurements taken with the reference device.

Read the detailed description

Individual sites are only representative of a subset of the overall population, per ISO 80601-2-56:2017(Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement), and therefore clinical bias and limits of agreement should not be evaluated for the subsets. Publication of results should include repeatability from individual sites and the combined clinical bias and limits of agreement (NCT05787782, NCT05674344, and NCT05779397)

Conditions: Fever
Being tested: Masimo Temperature device
Medical subject headings: Fever

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Masimo Temperature deviceDevice
Non-invasive temperature device

Study groups in NCT05674344
Study group	Role	What they receive
Masimo noninvasive temperature device	Experimental	All subjects who qualify for the trial and participate in data collection will have temperature taken using the Masimo noninvasive temperature device and the reference temperature device. Receives: Device: Masimo Temperature device

What is being measured

The primary outcome is the main question the study is designed to answer.

Accuracy of Masimo RAD-GT Temperature Measurments
The accuracy of the Masimo Rad-GT sensor will be determined by calculating the clinical bias (Δcb), limits of agreement (LA), and repeatability (σr). The temperature measurements from Masimo Rad-GT will be compared to the reference temperature measurements (degrees Celsius).
Measured: 15-30 Minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 20222 Mar 2023

First posted6 Jan 2023
Study start1 Dec 2022
Primary completion2 Mar 2023
Study completion2 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for FeverStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 170 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05674344
Sponsor's protocol ID: CHOC0008
Status last verified: Jun 2023
First submitted: 21 Dec 2022
Last updated: 25 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Fever trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Calibration and Validation of the Masimo Rad-G With Temperature Device in Febrile Patients
ClinicalTrials.gov ID: NCT05674344
Acronym / sponsor ID: CHOC0008
Conditions: Fever
Study type: Interventional
Recruitment status: Completed
Enrolment: 170 participants (actual)
Lead sponsor: Masimo CorporationIndustry (pharma, biotech, devices)
Study start: 1 Dec 2022 (actual)
Primary completion: 2 Mar 2023 (actual)
Study completion: 2 Mar 2023 (actual)
First posted: 6 Jan 2023 (actual)
Results: Posted 25 Jul 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Masimo noninvasive temperature device	Experimental	Device: Masimo Temperature deviceAll subjects who qualify for the trial and participate in data collection will have temperature taken using the Masimo noninvasive temperature device and the reference temperature device.

Who may qualify

Ages: 1 year and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Patients age ≥ 1year old
Febrile at time of enrollment: ≥ 99.5oF/37.5oC for patients ages 1-5 years; ≥ 100.4oF/38oC for patients older than 5 years old.
English- or Spanish-speaking patient or parent/LAR

Key exclusion criteria (2 listed)

Patients deemed not suitable for the study at the discretion of the investigator
Patients who are rated as a 1 or 2 Emergency Severity Index

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
Masimo Temperature deviceNon-invasive temperature device	Device	Masimo noninvasive temperature device

Primary outcome

Accuracy of Masimo RAD-GT Temperature Measurments
Time frame: 15-30 Minutes
The accuracy of the Masimo Rad-GT sensor will be determined by calculating the clinical bias (Δcb), limits of agreement (LA), and repeatability (σr). The temperature measurements from Masimo Rad-GT will be compared to the reference temperature measurements (degrees Celsius).

Results and safety

Results posted to the registry on 25 Jul 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Masimo Noninvasive Temperature Device	170	146

Primary outcome: Accuracy of Masimo RAD-GT Temperature Measurments

Time frame: 15-30 Minutes. Number. Unit: Degrees Celsius

Measure	Masimo Noninvasive Temperature Device n = 39
Clinical Bias	-0.24
Limits of Agreement	0.85
Repeatability	0.09

Population analysed: Subject 1 to 91 were part of the calibration phase of the study (91 subjects) and data was excluded from analysis. 14 excluded due to screen fails. Subject 92 to 170 (79 subjects) were part of the validation phase of the study. 10 screen fails. 4: Any subject who does not complete at least one full round of measurements. 26: Any subject whose data suggests existence of external conditions that interfere with RCT (reference clinical thermometer) or Rad-GT measurements.

Adverse events

Time frame: Approximately 15-30 minutes during data collection. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Masimo Noninvasive Temperature Device	0 of 170 (0%)	0 of 170 (0%)	0 of 170

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
NCT05787782, Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile SubejctsLink provided by the sponsor.
NCT05779397, Clinical Performance of Masimo Rad-GTLink provided by the sponsor.

Related trials for Fever

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Masimo Temperature device in people with Fever, run by Masimo Corporation at 1 site in United States.

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 3 inclusion and 2 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: finished, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

Yes. Results are posted in the registry (first posted 25 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Accuracy of Masimo RAD-GT Temperature Measurments (time frame: 15-30 Minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05674344.

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 25 Jul 2023.