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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05674344
Other study ID # CHOC0008
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2022
Est. completion date March 2, 2023

Study information

Verified date June 2023
Source Masimo Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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)


Recruitment information / eligibility

Status Completed
Enrollment 170
Est. completion date March 2, 2023
Est. primary completion date March 2, 2023
Accepts healthy volunteers No
Gender All
Age group 1 Year and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Masimo Temperature device
Non-invasive temperature device

Locations

Country Name City State
United States Site 1 Orange California

Sponsors (1)

Lead Sponsor Collaborator
Masimo Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Accuracy of Masimo RAD-GT Temperature Measurments The accuracy of the Masimo Rad-GT sensor will be determined by calculating the clinical bias (?cb), limits of agreement (LA), and repeatability (sr). The temperature measurements from Masimo Rad-GT will be compared to the reference temperature measurements (degrees Celsius). 15-30 Minutes
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