Temperature
Conditions
Brief summary
This clinical study is to validate temperature performance of the noninvasive Masimo INVSENSOR00048.
Interventions
DEVICEINVSENSOR00048
Noninvasive sensor will be attached to the subjects' skin with a medical grade biodegradable /adhesive, approximately 2 inches below the left clavicle to measure temperature
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Febrile subjects aged 18 years and older who meet the following criteria for screening temperature: * sublingual temperature ≥ 37.5°C (99.5°F), * or axillary temperature ≥ 37.2°C (99.0°F)
Exclusion criteria
* Subjects with medical conditions such as inflammation at the measuring site or taking medications which might skew clinical accuracy validation results (e.g. barbiturates, thyroid preparations, antipsychotics or immunization within prior 7 days) or per the investigator's judgement * 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 |
|---|---|---|
| Primary Outcome | Approximately 90 minutes | The 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 device under test (DUT) and reference thermometer. 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 | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 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 | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
None listed