Calibration and Validation of the Masimo Temperature Device in Febrile Patients
NCT ID: NCT05674344
Last Updated: 2023-07-25
Study Results
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View full resultsBasic Information
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COMPLETED
NA
170 participants
INTERVENTIONAL
2022-12-01
2023-03-02
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
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.
Masimo Temperature device
Non-invasive temperature device
Interventions
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Masimo Temperature device
Non-invasive temperature device
Eligibility Criteria
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Inclusion Criteria
* 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 who are rated as a 1 or 2 Emergency Severity Index
1 Year
ALL
No
Sponsors
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Masimo Corporation
INDUSTRY
Responsible Party
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Locations
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Site 1
Orange, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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NCT05787782, Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subejcts
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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