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In this study, the concentration of hemoglobin within the subject's blood will be reduced in a controlled manner by administering fluids intravenously. The accuracy of two noninvasive hemoglobin sensors will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group- Sensor 1 | Experimental | All subjects are enrolled into the test group and receive the Rainbow adhesive adult/pediatric sensors. |
|
| Group- Sensor 2 | Experimental | All subjects are enrolled into the test group and receive the Rainbow adhesive adult/neonatal sensors. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rainbow adhesive adult/pediatric sensor | Device |
| ||
| Rainbow adhesive adult/neonatal sensor |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of Noninvasive Sensors 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. The accuracy results from both sensors will be assessed for equivalence | 1-5 hours |
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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 | Rainbow Adhesive Adult/Pediatric Sensor | All subjects are enrolled into the test group and receive the Rainbow adhesive adult/pediatric sensors. |
| FG001 | Rainbow Adhesive Adult/Neonatal Sensor | All subjects are enrolled into the test group and receive the Rainbow adhesive adult/neonatal sensors. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rainbow Adhesive Adult/Pediatric and Adult/Neonatal Sensors | All subjects are enrolled into the test group and receive the Rainbow adhesive sensors (adult/pediatric and adult/neonatal sensors). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 Noninvasive Sensors 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. The accuracy results from both sensors will be assessed for equivalence | 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 | Rainbow Adhesive Adult/Pediatric and Adult/Neonatal Sensors | All subjects are enrolled into the test group and receive the Rainbow adhesive sensors (adult/pediatric and adult/neonatal). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tala Harake | Masimo | studies@masimo.com |
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| Device |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| 0 |
| 44 |
| 0 |
| 44 |
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