Healthy
Conditions
Brief summary
In this study, the concentration of hemoglobin was measured using noninvasive pulse oximeter sensors and compared against the hemoglobin measurement from the subject's blood sample under controlled conditions. Data collected in the study was in the sub-range of 11-17 g/dL in the device's 8-17 g/dL specification range. The purpose of the study was to evaluate a change in the sensor component and to assess performance equivalence in the sub-range. The performance of non-invasive hemoglobin is not uniform across the accuracy range.
Interventions
DEVICERainbow DCI and R1-25 sensor
Noninvasive Measurement of SpHb
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects must understand and consent to be in the study. * American Society of Anesthesiology Class 1 (Healthy subjects without any systemic disease at all).
Exclusion criteria
* Subjects who have any systemic disease at all. * Subjects who do not understand the study and the risks. * Smokers. * Subjects who are pregnant. * Subjects having either signs or history or peripheral ischemia. Others deemed ineligible by the clinical staff.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sub-Range Performance Equivalence of Rainbow DCI and R1-25 Sensors by ARMS Calculation | 1-5 hours per subject | Sub-range performance equivalence was determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter sensor to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value.In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the pulse oximeter hemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of these differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test Group All subjects are enrolled into the test group and all subjects received both the Rainbow DCI and R1-25 sensor. | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | Test Group |
|---|---|
| Age, Customized 26-65 years | 18 participants |
| Region of Enrollment United States | 18 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
Sub-Range Performance Equivalence of Rainbow DCI and R1-25 Sensors by ARMS Calculation
Sub-range performance equivalence was determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter sensor to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value.In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the pulse oximeter hemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of these differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.
Time frame: 1-5 hours per subject
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test Group | Sub-Range Performance Equivalence of Rainbow DCI and R1-25 Sensors by ARMS Calculation | Rainbow DCI | 1.2 g/dL |
| Test Group | Sub-Range Performance Equivalence of Rainbow DCI and R1-25 Sensors by ARMS Calculation | R1-25 | 1.2 g/dL |