Calibration and Validation of the Masimo Temperature Device in Febrile Patients

Masimo

Status: Completed

Conditions: Fever

Treatments: Device: Masimo Temperature device

Study type: Interventional

Funder types: Industry

Identifiers

NCT05674344

CHOC0008

Details and patient eligibility

About

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.

Full 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)

Enrollment: 170 patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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170 participants in 1 patient group

Masimo noninvasive temperature device

Experimental group

Description:

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.

Treatment:

Device: Masimo Temperature device