Fever
Conditions
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)
Interventions
DEVICEMasimo Temperature device
Non-invasive temperature device
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Masimo RAD-GT Temperature Measurments | 15-30 Minutes | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 170 |
| Total | 170 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Incomplete study procedures | 3 |
| Overall Study | Screen Fail | 21 |
Baseline characteristics
| Characteristic | Masimo Noninvasive Temperature Device |
|---|---|
| Age, Categorical <=18 years | 170 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 126 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 12 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 65 Participants |
| Race (NIH/OMB) White | 92 Participants |
| Region of Enrollment United States | 170 participants |
| Sex: Female, Male Female | 90 Participants |
| Sex: Female, Male Male | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 170 |
| other Total, other adverse events | 0 / 170 |
| serious Total, serious adverse events | 0 / 170 |
Outcome results
Primary
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).
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Masimo Noninvasive Temperature Device | Accuracy of Masimo RAD-GT Temperature Measurments | Clinical Bias | -0.24 Degrees Celsius |
| Masimo Noninvasive Temperature Device | Accuracy of Masimo RAD-GT Temperature Measurments | Limits of Agreement | 0.85 Degrees Celsius |
| Masimo Noninvasive Temperature Device | Accuracy of Masimo RAD-GT Temperature Measurments | Repeatability | 0.09 Degrees Celsius |