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This study is designed to measure the trending accuracy of a noninvasive measurement of cerebral oxygen saturation. One Large sensor (adult sensor) and one INVSENSOR00009 will be placed on the subject's forehead. The values obtained by the INVSENSOR00009 will be compared to the values collected with the adult sensor.Data will be collected from healthy adult subjects while undergoing a desaturation procedure wherein the concentration of oxygen inhaled is slowly reduced until the subject's arterial oxygen saturation is approximately 70%. The subject will then be returned to inhaling room air.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INVSENSOR00009 Sensor | Experimental | All subjects who are enrolled into the test group and participate in data collection receive both the INVSENSOR00009 and the control sensor simultaneously on the forehead. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INVSENSOR00009 | Device | All subjects who are enrolled into the test group and participate in data collection receive both the INVSENSOR00009 and the control sensor simultaneously on the forehead. |
| Measure | Description | Time Frame |
|---|---|---|
| Trending Regional Oxygen Saturation Accuracy of the INVSENSOR00009 Relative to the Control Sensor by Arms Calculation | Trending ARMs accuracy is defined as root mean squared relative error of all data points of all subjects. Accuracy of the sensors will be determined by comparing regional oxygen saturation (rSO2) readings from INVSENSOR00009 and control sensor and calculating the Arithmetic root mean square (ARMS) 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 | INVSENSOR00009 Sensor | All subjects who are enrolled into the test group and participate in data collection receive both the INVSENSOR00009 and the control sensor simultaneously on the forehead. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | INVSENSOR00009 Sensor | All subjects who are enrolled into the test group and participate in data collection receive both the INVSENSOR00009 and the control sensor simultaneously on the forehead. |
| 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 | One subject was withdrawn prior to completing study procedures. One subject did not meet criteria for data analysis. |
| 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 | Trending Regional Oxygen Saturation Accuracy of the INVSENSOR00009 Relative to the Control Sensor by Arms Calculation | Trending ARMs accuracy is defined as root mean squared relative error of all data points of all subjects. Accuracy of the sensors will be determined by comparing regional oxygen saturation (rSO2) readings from INVSENSOR00009 and control sensor and calculating the Arithmetic root mean square (ARMS) value. | Posted | Number | % tissue oxygen saturation | 1-5 hours |
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1 to 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 | INVSENSOR00009 Sensor | All subjects who are enrolled into the test group and participate in data collection receive both the INVSENSOR00009 and the control sensor simultaneously on the forehead. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tala Harake | Masimo Corporation | 949-297-7137 | studies@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 | Nov 21, 2017 | Jul 3, 2019 | Prot_SAP_000.pdf |
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| Count of Participants |
| Participants |
|
| Sex: Female, Male | One subject was withdrawn prior to completing study procedures. One subject did not meet criteria for data analysis. | Count of Participants | Participants |
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| Race/Ethnicity, Customized | One subject was withdrawn prior to completing study procedures. One subject did not meet criteria for data analysis. | Count of Participants | Participants |
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| Region of Enrollment | One subject was withdrawn prior to completing study procedures. One subject did not meet criteria for data analysis. | Count of Participants | Participants |
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| Counts |
|---|
| Participants |
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| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
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