NCT05674344

Calibration and Validation of the Masimo Temperature Device in Febrile Patients

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: Masimo Corporation · Industry
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

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)

Conditions

• Fever

Interventions

Type	Name	Description
DEVICE	Masimo Temperature device	Non-invasive temperature device

Timeline

• Start date: 2022-12-01
• Primary completion: 2023-03-02
• Completion: 2023-03-02
• First posted: 2023-01-06
• Last updated: 2023-07-25
• Results posted: 2023-07-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study