Trial Outcomes & Findings for Calibration and Validation of the Masimo Temperature Device in Febrile Patients (NCT NCT05674344)

Last Updated: 2023-07-25

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

170 participants

Primary outcome timeframe

15-30 Minutes

Results posted on

2023-07-25

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	170
Overall Study COMPLETED	146
Overall Study NOT COMPLETED	24

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Screen Fail	21
Overall Study Incomplete study procedures	3

Baseline Characteristics

Calibration and Validation of the Masimo Temperature Device in Febrile Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Masimo Noninvasive Temperature Device n=170 Participants 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
Age, Categorical <=18 years	170 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	90 Participants n=5 Participants
Sex: Female, Male Male	80 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	126 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	41 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	12 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	92 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	65 Participants n=5 Participants
Region of Enrollment United States	170 participants n=5 Participants

PRIMARY outcome

Timeframe: 15-30 Minutes

Population: Subject 1 to 91 were part of the calibration phase of the study (91 subjects) and data was excluded from analysis. 14 excluded due to screen fails. Subject 92 to 170 (79 subjects) were part of the validation phase of the study. 10 screen fails. 4: Any subject who does not complete at least one full round of measurements. 26: Any subject whose data suggests existence of external conditions that interfere with RCT (reference clinical thermometer) or Rad-GT measurements.

Outcome measures

Outcome measures
Measure	Masimo Noninvasive Temperature Device n=39 Participants 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
Accuracy of Masimo RAD-GT Temperature Measurments Clinical Bias	-0.24 Degrees Celsius
Accuracy of Masimo RAD-GT Temperature Measurments Limits of Agreement	0.85 Degrees Celsius
Accuracy of Masimo RAD-GT Temperature Measurments Repeatability	0.09 Degrees Celsius

Adverse Events

Masimo Noninvasive Temperature Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chelsea Frank

Masimo Corporation

Phone: (949) 297-7000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60