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In this study, the concentration of hemoglobin was measured using noninvasive pulse oximeter sensors and compared against the hemoglobin measurement from the subject's blood sample under controlled conditions. Data collected in the study was in the sub-range of 11-17 g/dL in the device's 8-17 g/dL specification range.
The purpose of the study was to evaluate a change in the sensor component and to assess performance equivalence in the sub-range. The performance of non-invasive hemoglobin is not uniform across the accuracy range.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group | Experimental | All subjects are enrolled into the test group and all subjects received both the Rainbow DCI and R1-25 sensor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rainbow DCI and R1-25 sensor | Device | Noninvasive Measurement of SpHb |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sub-Range Performance Equivalence of Rainbow DCI and R1-25 Sensors by ARMS Calculation | Sub-range performance equivalence was determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter sensor 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 these 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 | Irvine | California | 92618 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Group | All subjects are enrolled into the test group and all subjects received both the Rainbow DCI and R1-25 sensor. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Group | All subjects are enrolled into the test group and all subjects received both the Rainbow DCI and R1-25 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, Customized | Number |
| 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 | Sub-Range Performance Equivalence of Rainbow DCI and R1-25 Sensors by ARMS Calculation | Sub-range performance equivalence was determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter sensor 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 these 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 | Test Group | All subjects are enrolled into the test group and all subjects received both the Rainbow DCI and R1-25 sensor. |
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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 |
|
| Region of Enrollment | Number | participants |
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| 0 |
| 18 |
| 0 |
| 18 |
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