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The study goal is to establish the correlation of hemoglobin values determined by the noninvasive pulse oximetry-determined hemoglobin (SpHb) system with hemoglobin as measured by other validated devices. The study will also evaluation oxygen reserve index (ORI) to correlate with partial pressure of oxygen (PaO2), and to evaluate pleth variability index (PVI) with stroke volume variation (SVV) or pulse pressure variation (PPV) values.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | Experimental | All subjects will be enrolled into the test group and will receive Masimo Pulse CO-Oximeter for measurement of various physiological parameters. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Masimo Pulse CO-Oximeter | Device | Noninvasive pulse oximeter with various features for measurement of hemoglobin, pleth variability index, and oxygen reserve index |
|
| Measure | Description | Time Frame |
|---|---|---|
| Noninvasive Pulse Oximetry-determined SpHb Bias | Accuracy of SpHb will be determined by comparing it to the hemoglobin value obtained from a reference blood sample and calculating the accuracy root mean square (Arms) error value. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from SpHb 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. | Duration of study participation is up to three days. |
| Correlation of PVI Measurement Compared With PPV or SVV | Correlation of PVI measurement compared with pulse pressure variation PPV or stroke volume variation (SVV) measurement from arterial catheter | Duration of study participation is up to three days. |
| Correlation of "ORI" With Partial Pressure of Oxygen (PaO2) "PaO2" Measurement From Blood Gas Analysis | Concordance will be determined by comparing the trending ability of the Oxygen Reserve Index (ORI) measurement of the sensor with that of Partial Pressure of Oxygen in Blood (PaO2). | Duration of study participation is up to three days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Medical Center | Loma Linda | California | 92354 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Group | All subjects will be enrolled into the test group and will receive Masimo Pulse CO-Oximeter for measurement of various physiological parameters. Masimo Pulse CO-Oximeter: Noninvasive pulse oximeter with various features for measurement of hemoglobin, pleth variability index, and oxygen reserve index |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Group | All subjects will be enrolled into the test group and will receive Masimo Pulse CO-Oximeter for measurement of various physiological parameters. Masimo Pulse CO-Oximeter: Noninvasive pulse oximeter with various features for measurement of hemoglobin, pleth variability index, and oxygen reserve index |
| 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 | There were four subjects that did not complete the study. |
| 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 | Noninvasive Pulse Oximetry-determined SpHb Bias | Accuracy of SpHb will be determined by comparing it to the hemoglobin value obtained from a reference blood sample and calculating the accuracy root mean square (Arms) error value. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from SpHb 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. | A total of 12 subjects were excluded from data analysis Subjects were excluded from data analysis for different reasons. Reason 1: Blood sample could not be analyzed because received out of analyzer required time window Reason 2: Sensor data is not available Reason 3: No time matched sensor and blood sample data pair for analysis Reason 4: Reference tHb error. tHb difference >1g/dL between different methods | Posted | Number | g/dL | Duration of study participation is up to three days. |
|
Adverse events were monitored throughout study duration, which was up to three days.
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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 into the test group and will receive Masimo Pulse CO-Oximeter for measurement of various physiological parameters. Masimo Pulse CO-Oximeter: Noninvasive pulse oximeter with various features for measurement of hemoglobin, pleth variability index, and oxygen reserve index |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cristina Johnson | Masimo Corporation | (949) 297-7000 | clinicalresearchdept@masimo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 10, 2016 | Aug 20, 2021 | Prot_SAP_000.pdf |
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| Count of Participants |
| Participants |
|
| Sex: Female, Male | Please see reasons provided above. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Please see reasoning above. | Number | participants |
|
| OG000 |
| Test Group |
All subjects will be enrolled into the test group and will receive Masimo Pulse CO-Oximeter for measurement of various physiological parameters. Masimo Pulse CO-Oximeter: Noninvasive pulse oximeter with various features for measurement of hemoglobin, pleth variability index, and oxygen reserve index |
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| Primary | Correlation of PVI Measurement Compared With PPV or SVV | Correlation of PVI measurement compared with pulse pressure variation PPV or stroke volume variation (SVV) measurement from arterial catheter | There was no reference SVV or PPV data available for PVI data analysis. | Posted | Duration of study participation is up to three days. |
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| Primary | Correlation of "ORI" With Partial Pressure of Oxygen (PaO2) "PaO2" Measurement From Blood Gas Analysis | Concordance will be determined by comparing the trending ability of the Oxygen Reserve Index (ORI) measurement of the sensor with that of Partial Pressure of Oxygen in Blood (PaO2). | Data from 8 subjects were obtained. At least two samples per subject are required to compare ORI trending ability; however, only 1 sample was obtained from each subject which precluded conduct of any data analysis. | Posted | Duration of study participation is up to three days. |
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