Healthy
Conditions
Brief summary
The objective of this study is to evaluate the form, fit, and function of INVSENSOR00061 when used on newborn and infant subjects 0-18 months.
Interventions
DEVICEINVSENSOR00061
Noninvasive pulse oximetry and pulse rate device
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Months to 18 Months
Healthy volunteers
Yes
Inclusion criteria
* Subject is a full-term newborn (37 weeks) - up to 18 months of age. * The parent(s) or guardian(s) of minor subjects are able to read and communicate in English and understand the study and the risks involved.
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 has any medical condition which in the judgment of the investigator and/or study staff, renders them ineligible for participation in this study or subject is deemed ineligible by the discretion of the investigator/study staff.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| INVSENSOR00061 SpO2 Accuracy | 2 hours | The SpO2 accuracy of INVSENSOR00061 was determined by calculating the accuracy root mean squared (Arms) difference between the measured values (SpO2i) to the reference values (SpO2ref\_i) in accordance with ISO-80601-2-61. Arms= √(∑(i=1 to n) ((SpO2\_i-SpO2ref\_i )\^2 ))/n |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test Subjects All subjects who are enrolled into the test group and received the noninvasive INVENSOR00061.
INVSENSOR00061: Noninvasive pulse oximetry and pulse rate device | 52 |
| Total | 52 |
Baseline characteristics
| Characteristic | Test Subjects |
|---|---|
| Age, Categorical <=18 years | 52 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 21 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Region of Enrollment United States | 52 participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 53 |
| other Total, other adverse events | 0 / 53 |
| serious Total, serious adverse events | 0 / 53 |
Outcome results
Primary
INVSENSOR00061 SpO2 Accuracy
The SpO2 accuracy of INVSENSOR00061 was determined by calculating the accuracy root mean squared (Arms) difference between the measured values (SpO2i) to the reference values (SpO2ref\_i) in accordance with ISO-80601-2-61. Arms= √(∑(i=1 to n) ((SpO2\_i-SpO2ref\_i )\^2 ))/n
Time frame: 2 hours
Population: 11 subjects not included in analysis due to incorrect sensor placement. 29 subjects not included in analysis due to absence of reference sensor used to calculate Arms.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test Subjects | INVSENSOR00061 SpO2 Accuracy | 1.02 % of SpO2 |