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The study will collect cerebral oximetry data from pediatric and neonatal subjects using the Masimo O3 regional oximetry device, for the purposes of device calibration and validation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | Experimental | All subjects are enrolled in the test group and receive an O3 regional oximeter sensor during their scheduled, general cardiac catheterization procedure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| O3 regional oximeter sensor | Device | Noninvasive sensor that is placed on the forehead for measurement of oxygenation in the area under the sensor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of Sensor by Arms Calculation of Percent rSO2 | The continuous measurements of regional oxygen saturation (rSO2) was compared against its reference cerebral oxygen saturation which is measured by a combination of arterial and jugular venous blood oxygen saturation. Absolute accuracy was determined by the root-mean-squared error (Arms). The Arms error value is calculated as the square root of the sum of the squares of mean bias and estimated standard deviation of bias. The bias is defined as the difference of the rSO2 and its blood reference. | One visit; up to 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | O3 Regional Oximeter Sensors | All subjects are enrolled in the test group and receive O3 regional oximeter sensors during their scheduled, general cardiac catheterization procedure. O3 regional oximeter sensors: Noninvasive sensors are placed on the forehead for measurement of oxygenation in the area under the sensor |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The subjects included for the analysis are within the desired calibration range, with no sensor placement issues in the data collection time period.
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| ID | Title | Description |
|---|---|---|
| BG000 | O3 Regional Oximeter Sensors | All subjects are enrolled in the test group and receive the O3 regional oximeter sensor during their scheduled, general cardiac catheterization procedure. O3 regional oximeter sensor: Noninvasive sensors are placed on the forehead for measurement of oxygenation in the area under the sensor. |
| 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 Sensor by Arms Calculation of Percent rSO2 | The continuous measurements of regional oxygen saturation (rSO2) was compared against its reference cerebral oxygen saturation which is measured by a combination of arterial and jugular venous blood oxygen saturation. Absolute accuracy was determined by the root-mean-squared error (Arms). The Arms error value is calculated as the square root of the sum of the squares of mean bias and estimated standard deviation of bias. The bias is defined as the difference of the rSO2 and its blood reference. | Posted | Number | %rSO2 | One visit; up to 4 hours |
|
For each subject, adverse event data were collected up to 2 days after subject's single visit participation in the study.
Subjects were observed during the procedure, as well as contacted via phone call up to 2 days after the procedure to gather adverse event information.
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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 | O3 Regional Oximeter Sensors | All subjects are enrolled in the test group and receive an O3 regional oximeter sensor during their scheduled, general cardiac catheterization procedure. O3 regional oximeter sensor: Noninvasive sensor that is placed on the forehead for measurement of oxygenation in the area under the sensor |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild rash, localized to sensor location | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vikram Ramakanth | Masimo Corporation | 1 (949) 297-7416 | 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 | Yes | No | No | Study Protocol | Dec 2, 2014 | May 9, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 9, 2018 | May 9, 2018 | SAP_001.pdf |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 44 |
| 0 |
| 44 |
| 2 |
| 44 |
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