Fever
Conditions
Brief summary
This is a prospective, non-randomized data collection study to evaluate the performance of the Masimo INVSENSOR00063 in obtaining 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 (NCT05787782, NCT05674344 and NCT05779397).
Interventions
DEVICEMasimo INVSENSOR00063
Masimo INVSENSOR00063 will be used to measure temperature
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
Yes
Inclusion criteria
* Participant age ≥ 1 year * Afebrile or febrile at time of enrollment: For febrile subjects, ≥ 99.5 F/ 37.5 C for sublingual temperature reference; ≥ 100.4 F/ 38 C for temporal artery temperature reference. * English-or Spanish-speaking patient or parent/Legal Guardian
Exclusion criteria
* Participants deemed not suitable for the study at the discretion of the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Temperature Measurements Using Masimo INVSENSOR00063 | About 15-30 minutes | Masimo INVSENSOR00063 temperature measurements will be compared to reference temperature measurements. Accuracy of Masimo INVSENSOR00063 will be measured using clinical bias, limits of agreement and repeatability. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Masimo INVSENSOR00063 All subjects are enrolled into this arm and will have temperature measurements obtained.
Masimo INVSENSOR00063: Masimo INVSENSOR00063 will be used to measure temperature | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | Masimo INVSENSOR00063 |
|---|---|
| Age, Categorical <=18 years | 31 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 38 Participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 60 |
| other Total, other adverse events | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 |
Outcome results
Primary
Accuracy of Temperature Measurements Using Masimo INVSENSOR00063
Masimo INVSENSOR00063 temperature measurements will be compared to reference temperature measurements. Accuracy of Masimo INVSENSOR00063 will be measured using clinical bias, limits of agreement and repeatability.
Time frame: About 15-30 minutes
Population: Data for 1 subject was excluded as they did not complete one round of measurements.~Data for 1 subject was excluded as the data suggested existence of external conditions that interefere with RCT (reference clinical thermometer) or Masimo INVSENSOR00063 measurements.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Masimo INVSENSOR00063 | Accuracy of Temperature Measurements Using Masimo INVSENSOR00063 | Clinical Bias | -0.24 Degrees Celsius |
| Masimo INVSENSOR00063 | Accuracy of Temperature Measurements Using Masimo INVSENSOR00063 | Limits of Agreement | 0.85 Degrees Celsius |
| Masimo INVSENSOR00063 | Accuracy of Temperature Measurements Using Masimo INVSENSOR00063 | Repeatability | 0.05 Degrees Celsius |