Fever, Healthy
Conditions
Brief summary
The objective of this clinical study is to validate temperature performance of the noninvasive Masimo INVSENSOR00048.
Interventions
DEVICEMasimo INVSENSOR00048
Masimo INVSENSOR00048 will be used to collect temperature measurements.
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Afebrile subjects of all ages, or febrile subjects of all ages who meet the following criteria for screening temperature: * sublingual temperature ≥ 37.5°C (99.5°F), * rectal temperature ≥ 38.0°C (100.4°F), * or axillary temperature ≥ 37.2°C (99.0°F) * If subject is \< 18 years old, parents or legally authorized representatives (LAR) have provided informed consent and have signed all necessary related documents
Exclusion criteria
* Subjects with medical conditions such as inflammation at the measuring site or taking medications e.g. barbiturates, thyroid preparations, antipsychotics, or immunization within prior 7 days, which might skew clinical accuracy validation results such as, per the investigator's judgement * Subjects unable to provide informed consent or assent, as appropriate * Subjects with conditions at or around site of sensor placement or skin abnormalities affecting the sensor placement area such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown that would prevent monitoring of physiological parameters during the study * Subjects with known allergies to adhesive material used in medical equipment * Subjects with medical conditions which, in the judgment of the investigator, renders them inappropriate for participation in this study * Excluded at the Principal Investigator's discretion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Performance of Masimo INVSENSOR00048 | Approximately 90 minutes | The outcome measure is determination of the Masimo INVSENSOR00048 temperature performance by comparing the Clinical Bias and Limits of Agreement (LOA) between the corresponding adjustment mode temperature of the INVSENSOR00048 and reference thermometer in degrees celsius. Clincal Bias is defined as mean difference between output temperatires of a clinical thermometer and a reference clinical thermometer for the intended reference body site with specified limitis of agreement when measured from selected group of subjects . Limits of agreement is defined as the magnitude of a potential disagreement between outputs of two clinical thermometers equal to double the standard deviation of output temperate differences when used on the same human subject . |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 109 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 10 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 21 Participants |
| Race (NIH/OMB) White | 66 Participants |
| Sex: Female, Male Female | 71 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 180 |
| other Total, other adverse events | 1 / 180 |
| serious Total, serious adverse events | 0 / 180 |
Outcome results
None listed