Oxygen Saturation
Conditions
Keywords
Oxygen Saturation, SpO2
Brief summary
This clinical investigation is to collect data to provide additional support for form, fit, and function of INVSENSOR00045 in the neonatal clinical environment when used by hospital's personnel and reference co-oximeter.
Interventions
DEVICEINVSENSOR00045
Noninvasive sensor will be fitted to the subject's hand, foot, or toe to measure oxygen saturation and pulse rate.
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Months
Healthy volunteers
Yes
Inclusion criteria
* Less than or equal to 1 month of age * Gestational age greater than 23 weeks * Weight less than or equal to 5 kg * Subjects with standard of care arterial blood sampling line already in place
Exclusion criteria
* Subjects with underdeveloped skin * Subjects with abnormalities at the planned application sites that would interfere with system measurements * Subjects with known allergic reactions to foam/rubber products and adhesive tape * Subjects with axillary arterial lines * Deformities of the limbs, absence of the feet, severe edema, and other at the discretion of the Principal Investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Form, Fit and Function of INVSENSOR00045. | Up to 8 hours per subject. | To observe form, fit, and function of the INVSENSOR00045 sensors in the neonatal population with convenience sampling in a clinical environment. Data collected using the sensors will be compared to the reference values (RMS). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| INVSENSOR00045 All subjects are enrolled into the test group and are fitted with a non-invasive pulse oximetry sensor called INVSENSOR00045 during their stay at the hospital.
INVSENSOR00045: Noninvasive sensor will be fitted to the subject's hand, foot, or toe to measure oxygen saturation and pulse rate. | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | INVSENSOR00045 |
|---|---|
| Age, Categorical <=18 years | 7 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Race/Ethnicity, Customized Hispanic, Latino, or Spanish Origin | 3 participants |
| Race/Ethnicity, Customized Non-Hispanic, Latino or Spanish Origin | 2 participants |
| Race/Ethnicity, Customized Not Reported | 2 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 | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 7 |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
Form, Fit and Function of INVSENSOR00045.
To observe form, fit, and function of the INVSENSOR00045 sensors in the neonatal population with convenience sampling in a clinical environment. Data collected using the sensors will be compared to the reference values (RMS).
Time frame: Up to 8 hours per subject.
Population: Data was obtained from all participants and there were no signal quality issues. The study was terminated early and the sample size was insufficient to statistically compare data collected to the reference values. Hence, the root mean square error (RMS) could not be computed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| INVSENSOR00045 | Form, Fit and Function of INVSENSOR00045. | 0 number of issues with form/fit &function |