Calibration and Validation of the Masimo Temperature Device in Febrile Patients

Study Overview
=================
Brief 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 forehead thermometer. 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.

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)

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

Conditions
-----------------
Fever

Intervention / Treatment
-----------------
* Device: Masimo Temperature device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Masimo noninvasive temperature device<br>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. | Device: Masimo Temperature device<br>* Non-invasive temperature device<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 15-30 Minutes |