N/A N=170 Other

Calibration and Validation of the Masimo Temperature Device in Febrile Patients

Fever

Bottom Line

View on ClinicalTrials.gov: NCT05674344 ↗

Enrolled (actual)

170

Serious AEs

0.0%

Results posted

Jul 2023

Primary outcome: Primary: Accuracy of Masimo RAD-GT Temperature Measurments — -0.24; 0.85; 0.09 Degrees Celsius

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Masimo Temperature device (Device)
Age: Pediatric, Adult, Older Adult · 1+ yrs
Sex: All
Sponsor: Masimo Corporation
Primary completion: Mar 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Accuracy of Masimo RAD-GT Temperature Measurments	-0.24; 0.85; 0.09	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05674344). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.