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In this study, the accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory hematology analyzer. Blood samples are collected from healthy volunteers who are enrolled in either a blood draw procedure or a hemodilution procedure wherein blood is repeatedly sampled as the concentration of hemoglobin is reduced in a controlled manner by administering fluids intravenously.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Noninvasive Hemoglobin Sensor | Experimental | All subjects are enrolled into the test group and all subjects received the Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI, DCIP) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemoglobin Sensor ((Rainbow Reusable DCI, DCIP)) | Device | Measurement of Noninvasive Hemoglobin (SpHb) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of Sensor 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. | 1-5 hours |
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A. Hemodilution Test Procedure
Inclusion Criteria:
Exclusion Criteria
B. Blood Draw Test Procedure
Inclusion Criteria:
-Subjects must understand and consent to be in the study.
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masimo Corporation | Irvine | California | 92618 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Noninvasive Hemoglobin Sensor | All subjects are enrolled into the test group and all subjects received the Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI, DCIP) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Noninvasive Hemoglobin Sensor | All subjects are enrolled into the test group and all subjects received the Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI, DCIP) |
| Units | Counts |
|---|---|
| Participants |
|
| 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 Sensor 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. | Posted | Number | g/dL | 1-5 hours | data points | data points |
|
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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 | Noninvasive Hemoglobin Sensor | All subjects are enrolled into the test group and all subjects received the Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI, DCIP) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tala Harake | Masimo | studies@masimo.com |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| data points |
|
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| 0 |
| 354 |
| 0 |
| 354 |
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