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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 12-17 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 will be enrolled in the test group and will receive both R1-25 and R2-25 Pulse Oximeter Sensors |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| R1-25 and R2-25 Pulse Oximeter Sensor | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sub-Range Performance Equivalence of R2-25 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 |
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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 | Test Group | All subjects will be enrolled in the test group and will receive both R1-25 and R2-25 Pulse Oximeter Sensors |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Group | All subjects will be enrolled in the test group and will receive both R1-25 and R2-25 Pulse Oximeter Sensors |
| 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 | Sub-Range Performance Equivalence of R2-25 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 |
|
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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 will be enrolled in the test group and will receive both R1-25 and R2-25 Pulse Oximeter Sensors |
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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 | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| 0 |
| 21 |
| 0 |
| 21 |
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