Spo2
Conditions
Brief summary
This is a prospective, non-randomized data collection study to evaluate the form, fit, and function of INVSENSOR00061.
Interventions
DEVICEMasimo INVSENSOR00061
Masimo INVSENSOR00061 will be used to measure noninvasive SpO2 (Oxygen Saturation )
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
37 Weeks to 18 Months
Healthy volunteers
Yes
Inclusion criteria
* • Subject is a full-term newborn (37 weeks) to 18 months of age.
Exclusion criteria
* • Subject has underdeveloped skin. * Subject has a skin condition and/or deformity at the planned application site, which would preclude sensor placement and measurements. * Subject has an absence or deformities of limbs or severe edema, which would interfere with sensor application or prevent the proper fit of the sensors. * Subject is not suitable for the investigation at the discretion of the Investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SpO2 Accuracy of INVSENSOR00061 | Approximately 15 minutes | SpO2 accuracy will be determined by calculating the Arithmetic Root Mean Square (ARMs) value which will be reported as percent of oxygen saturated hemoglobin. The noninvasive oxygen saturation measurement (SpO2) from the INVSENSOR00061 will be compared to the noninvasive oxygen saturation measurement (SpO2) value from the RD SET Neo sensor. |
| Pulse Rate Accuracy of INVSENSOR00061 | Approximately 15 minutes | Pulse Rate accuracy will be determined by calculating the Arithmetic Root Mean Square (ARMs) value through the comparison of the noninvasive Pulse Rate to the noninvasive Pulse Rate (PR) value obtained from the RD SET Neo sensor which will be reported as beats per minute. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Masimo INVSENSOR00061 Experimental: INVSENSOR00061 All subjects are enrolled into this arm will have noninvasive blood oxygen measurements obtained.
Masimo INVSENSOR00061: Masimo INVSENSOR00061 will be used to measure noninvasive SpO2 (Oxygen Saturation ) | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | Masimo INVSENSOR00061 |
|---|---|
| Age, Categorical <=18 years | 60 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 32 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 38 Participants |
| Region of Enrollment United States | 60 participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 35 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
Pulse Rate Accuracy of INVSENSOR00061
Pulse Rate accuracy will be determined by calculating the Arithmetic Root Mean Square (ARMs) value through the comparison of the noninvasive Pulse Rate to the noninvasive Pulse Rate (PR) value obtained from the RD SET Neo sensor which will be reported as beats per minute.
Time frame: Approximately 15 minutes
Population: 30 subjects were excluded from the analysis and replaced with new participants because of incorrect sensor placement.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Masimo INVSENSOR00061 | Pulse Rate Accuracy of INVSENSOR00061 | 4.45 beats per minute |
Primary
SpO2 Accuracy of INVSENSOR00061
SpO2 accuracy will be determined by calculating the Arithmetic Root Mean Square (ARMs) value which will be reported as percent of oxygen saturated hemoglobin. The noninvasive oxygen saturation measurement (SpO2) from the INVSENSOR00061 will be compared to the noninvasive oxygen saturation measurement (SpO2) value from the RD SET Neo sensor.
Time frame: Approximately 15 minutes
Population: 30 subjects were excluded from the analysis and replaced with new participants because of incorrect sensor placement.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Masimo INVSENSOR00061 | SpO2 Accuracy of INVSENSOR00061 | 0.87 percent of oxygen saturated hemoglobin |