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A study to test the accuracy of SpO2 sensors with various patient monitors, co-oximeters, and modules.
The U-TruSignal with different sensors is feasible for noninvasive and continuous SpO2 monitoring and meets the specified measurement accuracy when compared to a co-oximetry gold reference.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulse oximetry monitoring | Experimental | The U-TruSignal with different sensors is feasible for noninvasive and continuous SpO2 monitoring and meets the specified measurement accuracy when compared to a co-oximetry gold reference. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulse oximetry | Device | Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy Root Mean Square (ARMS) | The Accuracy Root Mean Square (ARMS) calculation is used to measure accuracy of the test SpO2 device compared to reference SpO2 device. A scatterplot is created with the forehead sensor saturation on the y-axis and the measured blood saturation on the x-axis. The line of identity is drawn representing the ideal points, meaning that the forehead sensor saturation is always the same as the blood saturation. The dispersion of the actual data points around the line of identity can be measured using a statistical calculation called Arithmetic Root Mean Square (ARMS). The smaller ARMs the closer the data points lie around the line of identity, representing a more accurate sensor as accurate and appropriate. Data analysis follows ISO 80601-2-61, 2011, Annex EE and the FDA Guidance Document for Pulse Oximeters (FDA Draft Guidance, July 19, 2007). | 60 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Conner | GEHC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinimark | Louisville | Colorado | 80027 | United States |
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The first subject was enrolled on June19, 2012 and the last subject was enrolled on February 15, 2013. The study was conducted at Clinimark, a human performance laboratory that tests physiological monitoring devices.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pulse Oximetry Monitoring | Pulse oximetry : Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
63 subjects were enrolled. Data from 51 subjects was used for analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pulse Oximetry Monitoring | Pulse Oximetry Monitoring Single Arm |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Accuracy Root Mean Square (ARMS) | The Accuracy Root Mean Square (ARMS) calculation is used to measure accuracy of the test SpO2 device compared to reference SpO2 device. A scatterplot is created with the forehead sensor saturation on the y-axis and the measured blood saturation on the x-axis. The line of identity is drawn representing the ideal points, meaning that the forehead sensor saturation is always the same as the blood saturation. The dispersion of the actual data points around the line of identity can be measured using a statistical calculation called Arithmetic Root Mean Square (ARMS). The smaller ARMs the closer the data points lie around the line of identity, representing a more accurate sensor as accurate and appropriate. Data analysis follows ISO 80601-2-61, 2011, Annex EE and the FDA Guidance Document for Pulse Oximeters (FDA Draft Guidance, July 19, 2007). | The data analyzed was SpO2 data pairs using different U-Trusginal SpO2 sensors, patient monitors, co-oximeters, and various modules. Multiple data pairs were collected from each study participant, but not all sensors, patient monitors, co-oximeters and module configurations were used with each participant. | Posted | Mean | Full Range | Accuracy Root Mean Square | 60 minutes | Number of Data Pairs | Number of Data Pairs |
1 month
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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 | TS-AAW Sensor + 3900 Oximeter | Pulse oximetry : Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Conner | GEHealthcare | 414-477-8374 | Jeffrey.Conner@ge.com |
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| ID | Term |
|---|---|
| D010092 | Oximetry |
| ID | Term |
|---|---|
| D001784 | Blood Gas Analysis |
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| SpO2 | Mean | Standard Deviation | % oxygen |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Pulse Oximetry Monitoring Using SpO@ Sensors | Pulse oximetry measurement using different U-Trusginal SpO2 sensors, patient monitors, co-oximeters, and various modules. |
|
|
| 0 |
| 63 |
| 0 |
| 63 |
| 0 |
| 63 |
| EG001 | TS-AAW Sensor + B40 Patient Monitor | Pulse oximetry : Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules. | 0 | 63 | 0 | 63 | 0 | 63 |
| EG002 | TS-AAW Sensor + Carescape V100 With TruSignal V2 SpO2 Board | Pulse oximetry : Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules. | 0 | 63 | 0 | 63 | 0 | 63 |
| EG003 | TS-AAW Sensor + Carescape V100 | Pulse oximetry : Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules. | 0 | 63 | 0 | 63 | 0 | 63 |
| EG004 | TS-AAW Sensor + EPRESTN | Pulse oximetry : Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules. | 0 | 63 | 0 | 63 | 0 | 63 |
| EG005 | TS-AAW Sensor + M-NESTPR | Pulse oximetry : Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules. | 0 | 63 | 0 | 63 | 0 | 63 |
| EG006 | TS-AAW Sensor + M-OSAT | Pulse oximetry : Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules. | 0 | 63 | 0 | 63 | 0 | 63 |
| EG007 | TS-AAW Sensor + TruSat | Pulse oximetry : Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules. | 0 | 63 | 0 | 63 | 0 | 63 |
| EG008 | TS-AAW Sensor + TuffSat | Pulse oximetry : Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules. | 0 | 63 | 0 | 63 | 0 | 63 |
| EG009 | TS-SA-D Sensor + Carescape V100 With TruSignal V2 SpO2 Board | Pulse oximetry : Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules. | 0 | 63 | 0 | 63 | 0 | 63 |
The sponsor cannot require changes to the PI's disclosure, with the exception of requesting the removal of sponsor's confidential information. The study results themselves are not considered confidential information. Sponsor cannot extend the embargo beyond 60 days unless the PI's disclosure contains patentable subject matter, in which an embargo beyond 60 days may be necessary to allow for the filing of a patent application
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D008919 | Investigative Techniques |