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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R1-25 Sensor | Experimental | All subjects will be enrolled in the test group and will receive Rainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1-5 hours per subject |
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Inclusion Criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masimo Clinical Lab | Irvine | California | 92618 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | g/dL | 1-5 hours per subject |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | R1-25 Sensor | All subjects will be enrolled in the test group and will receive Rainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vikram Ramakanth | Masimo | clinicalresearchdept@masimo.com |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
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| Participants |
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| 25 |
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| 25 |
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