Back to resultsCalibration and Validation of the Masimo Temperature Device in Febrile Patients
Primary Purpose
Fever
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Masimo Temperature device
Sponsored by
About this trial
This is an interventional other trial for Fever
Eligibility Criteria
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
Sites / Locations
- Site 1
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Masimo noninvasive temperature device
Arm 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.
Outcomes
Primary Outcome Measures
Accuracy of Masimo RAD-GT Temperature Measurments
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05674344
Brief Title
Calibration and Validation of the Masimo Temperature Device in Febrile Patients
Official Title
Calibration and Validation of the Masimo Rad-G With Temperature Device in Febrile Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
March 2, 2023 (Actual)
Study Completion Date
March 2, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masimo Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
Brief 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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fever
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
170 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Masimo noninvasive temperature device
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Masimo Temperature device
Intervention Description
Non-invasive temperature device
Primary Outcome Measure Information:
Title
Accuracy of Masimo RAD-GT Temperature Measurments
Description
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).
Time Frame
15-30 Minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Site 1
City
Orange
State/Province
California
ZIP/Postal Code
92630
Country
United States
12. IPD Sharing Statement
Links:
URL
https://clinicaltrials.gov/ct2/show/NCT05787782?term=koei0004&draw=2&rank=1
Description
NCT05787782, Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subejcts
URL
http://clinicaltrials.gov/ct2/show/NCT05779397?term=CIP-1064&draw=2&rank=1
Description
NCT05779397, Clinical Performance of Masimo Rad-GT
Learn more about this trial
Calibration and Validation of the Masimo Temperature Device in Febrile Patients
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