Evaluation of SpO2 Performance
Conditions
Brief summary
This is a prospective, non-randomized, single arm study design to evaluate SpO2 performance of the RD SET Neo investigational pulse oximeter sensors in the neonatal population using convenience sampling in a clinical environment. The initial subjects under Protocol Version 1 were enrolled as part of a feasibility study to verify the design changes to the sensor are correct. The study protocol was amended with Protocol Version 2 to enroll a group of subjects that will be used to evaluate clinical performance for submission to regulatory agencies.
Interventions
DEVICERD SET Neo SpO2
All subjects are enrolled in the experimental group and receive the RD SET Neo SpO2 sensor.
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 * Weight \<3kg * Subjects admitted with standard of care (SOC) 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 * Deformities of limbs, absence of feet, sever edema, and other at the discretion of the Principal Investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Oxygen Saturation (SpO2) Measurement by RMS Calculation | up to 8 hours | Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the root mean square (RMS) error value. In order to obtain the RMS value, the blood oxygen saturation measurement form a laboratory pulse Co-Oximeter is subtracted from the pulse oximeter oxygen saturation measurement for each sample, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the RMS Error value. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| RD SET Neo SpO2 All subjects enrolled in the study will receive the investigational sensor (RD SET Neo SpO2) for evaluation of SpO2.
RD SET Neo SpO2: All subjects are enrolled in the experimental group and receive the RD SET Neo SpO2 sensor. | 28 |
| Total | 28 |
Baseline characteristics
| Characteristic | RD SET Neo SpO2 |
|---|---|
| Age, Categorical <=18 years | 28 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 | 3 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 | 10 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 28 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 28 |
| other Total, other adverse events | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
Primary
Accuracy of Oxygen Saturation (SpO2) Measurement by RMS Calculation
Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the root mean square (RMS) error value. In order to obtain the RMS value, the blood oxygen saturation measurement form a laboratory pulse Co-Oximeter is subtracted from the pulse oximeter oxygen saturation measurement for each sample, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the RMS Error value.
Time frame: up to 8 hours
Population: Subject 7 \& 11: Protocol deviation Subject 19 \& 26: Outlier data points Subject 5: Removed per ISO standard for SpO2 equal to 100.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RD SET Neo SpO2 | Accuracy of Oxygen Saturation (SpO2) Measurement by RMS Calculation | 2.1 percent of oxygen saturated hemoglobin |