Calibration and Validation of the Masimo Temperature Device in Febrile Patients

Fever Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05674344
• Other study ID #: CHOC0008
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Fever
• Hyperthermia

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

External Links

•   NCT05779397, Clinical Performance of Masimo Rad-GT
•   NCT05787782, Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subejcts