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Completed

NCT Number: NCT05674344

Calibration and Validation of the Masimo Temperature Device in Febrile Patients

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.

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Key information

Conditions

Fever Body Temperature Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Site 1

Orange, California, 92630, United States

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Masimo Temperature device

Device

Non-invasive temperature device

Primary outcomes

  1. Accuracy of Masimo RAD-GT Temperature Measurments

    Time frame: 15-30 Minutes

    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).

Sponsors and collaborators

Lead sponsor

Masimo Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 6, 2023
Registry last updated
Jul 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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