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In this study, the level of methemoglobin (HbMet) will be increased in a controlled manner by administering sodium nitrite intravenously in healthy volunteers. The accuracy of the noninvasive HbMet measurement by a Pulse Oximeter Sensor will be assessed by comparison to blood measurements from a laboratory analyzer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R2-25 Sensor | Experimental | All subjects will be enrolled in the test group and will receive R2-25 Pulse Oximeter Sensor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulse Oximeter Sensor | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of Methemoglobin Measurement by Arms Calculation | Accuracy willl be determined by comparing the noninvasive blood methemoglobin measurement (expressed as a percentage of total hemoglobin) of the pulse oximeter to that 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 methemoglobin value is subtracted from the pulse oximeter methemoglobin 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of San Francisco | San Francisco | California | 94117 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | R2-25 Sensor | All subjects will be enrolled in the test group and will receive R2-25 Pulse Oximeter Sensor Pulse Oximeter Sensor |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | R2-25 Sensor | All subjects will be enrolled in the test group and will receive R2-25 Pulse Oximeter Sensor 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 Methemoglobin Measurement by Arms Calculation | Accuracy willl be determined by comparing the noninvasive blood methemoglobin measurement (expressed as a percentage of total hemoglobin) of the pulse oximeter to that 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 methemoglobin value is subtracted from the pulse oximeter methemoglobin 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 | percentage of total hemoglobin | 1-5 hours |
|
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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 | R2-25 Sensor | All subjects will be enrolled in the test group and will receive R2-25 Pulse Oximeter Sensor 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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| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
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