Healthy
Conditions
Brief summary
The study is designed to validate the clinical performance of Masimo Rad-GT in the accuracy of temperature measurements.
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 (NCT05779397, NCT05787782, and NCT05674344).
Interventions
DEVICEMasimo RAD-GT
Non-contact infrared thermometry device
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject is 18 to 80 years of age. * Subjects are able to read and communicate in English as well as understand the study and the risks involved.
Exclusion criteria
* Subject is pregnant or nursing. * Subject has a known neurological and/or psychiatric disorder (e.g., schizophrenia, bipolar disorder, Multiple Sclerosis, Huntington's disease) that interferes with the subject's level of consciousness. \* * Subject has any medical condition which in the judgment of the investigator and/or study staff, renders them ineligible for participation in this study or subject is deemed ineligible by the discretion of the investigator/study staff. (\* = Per study staff discretion)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Masimo Rad-GT Temperature Measurements (Degrees Celsius) | 1-3 hours | 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
Pre-assignment details
Of the 68 enrolled participants, 68 completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Rad-GT All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo RAD-GT
Masimo RAD-GT: Non-contact infrared thermometry device | 68 |
| Total | 68 |
Baseline characteristics
| Characteristic | Rad-GT |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 68 Participants |
| Race/Ethnicity, Customized Ethnicity Asian or Pacific Islander | 23 Participants |
| Race/Ethnicity, Customized Ethnicity Caucasian | 32 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic | 5 Participants |
| Race/Ethnicity, Customized Ethnicity More than one | 2 Participants |
| Race/Ethnicity, Customized Ethnicity Other | 6 Participants |
| Region of Enrollment United States | 68 Participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 68 |
| other Total, other adverse events | 0 / 68 |
| serious Total, serious adverse events | 0 / 68 |
Outcome results
Primary
Accuracy of Masimo Rad-GT Temperature Measurements (Degrees Celsius)
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: 1-3 hours
Population: Data for 7 subjects was excluded as they did not complete at least one full one round of measurements.~Data for 37 subjects was excluded as the data suggested existence of external conditions that interfere with RCT (reference clinical thermometer) or Rad-GT measurements.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rad-GT | Accuracy of Masimo Rad-GT Temperature Measurements (Degrees Celsius) | Clinical Bias | -0.24 Degrees Celsius |
| Rad-GT | Accuracy of Masimo Rad-GT Temperature Measurements (Degrees Celsius) | Limits of Agreement | 0.85 Degrees Celsius |
| Rad-GT | Accuracy of Masimo Rad-GT Temperature Measurements (Degrees Celsius) | Repeatability | 0.04 Degrees Celsius |