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Collect continuous systolic and diastolic blood pressure values and waveforms as recorded by an arterial line catheter and by non-invasive blood pressure (NIBP) and to collect Photoplethysmogram Pulse Oximetry (PPG) waveform in order to optimize the Sensifree algorithm.
Sensifree is developing a continuous non-invasive blood pressure measurement system, that uses a fingertip PPG sensor as a signal source. The system provides systolic, diastolic and mean arterial pressure values, for use in hospitals and other clinical settings. The PPG waveform is analyzed by a proprietary software algorithm, calculating BP values.
The current best method to obtain similar information is by using an Arterial line catheter which will serve as a reference device. In this study, the sponsor aims to prospectively collect continuous radial arterial line & PPG waveforms, as well as NIBP data over the period of the surgery in order to test and refine the algorithm.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arterial catheterization kit | Device | Invasive monitoring of blood pressure via catheterization of the radial artery, displaying a continuous pressure waveform and blood pressure values. | ||
| GE Datex-Ohmeda Finger Clip Pulse Oximeter Sensor | Device | PPG fingertip mounted sensor, that measures the oxygen level (oxygen saturation) of the blood and generates a waveform | ||
| NIBP Cuff (GE Healthcare) | Device | A blood pressure cuff is used to measure blood pressure. The cuff has an inflatable rubber bladder that is typically fastened around the arm. A pressure meter indicates the cuff's pressure. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of BP values between a PPG sensor based device and an arterial line | PPG signal will be acquired from the PPG sensor, while blood pressure values (systolic, diastolic, mean) will be acquired from A-line. PPG signal will be analyzed by the Sensifree's algorithm and compared to the A-line BP measurement results according to ISO 81060-2 accuracy specifications | The length of each procedure, typically up to 8 hours |
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Inclusion Criteria:
Exclusion Criteria:
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Patients scheduled for elective surgery involving placement of radial artery A-line for BP monitoring
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| Name | Affiliation | Role |
|---|---|---|
| Arthur Wallace, MD, PhD | San Francisco Veterans Affairs Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco Veterans Affairs Medical Center | San Francisco | California | 94121 | United States |
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