Healthy
Conditions
Brief summary
In this study, the concentration of hemoglobin will be measured using a noninvasive pulse oximeter sensor and compared with the hemoglobin value from a blood sample of the volunteer. The accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.
Interventions
DEVICERainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Greater than 18 years old * Healthy
Exclusion criteria
* Do not understand the study and the risks involved * Deemed ineligible by study test personnel
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of SpHb on R1-25 by Arms Calculation | 1-5 hours per subject | Accuracy will be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter 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 the 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 |
|---|---|
| R1-25 Sensor All subjects will be enrolled in the test group and will receive Rainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor
Rainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | R1-25 Sensor |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
Accuracy of SpHb on R1-25 by Arms Calculation
Accuracy will be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter 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 the 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 | Value (NUMBER) |
|---|---|---|
| R1-25 Sensor | Accuracy of SpHb on R1-25 by Arms Calculation | 1.0 g/dL |