Calibration and Validation of the Masimo Temperature Device in Febrile Patients

NCT ID: NCT05674344

Last Updated: 2023-07-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2023-03-02

Brief Summary

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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

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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

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Fever

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Masimo noninvasive temperature device

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.

Group Type EXPERIMENTAL

Masimo Temperature device

Intervention Type DEVICE

Non-invasive temperature device

Interventions

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Masimo Temperature device

Non-invasive temperature device

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Masimo Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Site 1

Orange, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://clinicaltrials.gov/ct2/show/NCT05787782?term=koei0004&draw=2&rank=1

NCT05787782, Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subejcts

http://clinicaltrials.gov/ct2/show/NCT05779397?term=CIP-1064&draw=2&rank=1

NCT05779397, Clinical Performance of Masimo Rad-GT

Other Identifiers

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CHOC0008

Identifier Type: -

Identifier Source: org_study_id

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