Data Collection of Arterial Line Waveform and BP Values

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.

• 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.

Primary outcomes

• Comparison of BP values between a PPG sensor based device and an arterial line [The length of each procedure, typically up to 8 hours]: 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

Sex: All, ages: 18 Years to 80 Years

Inclusion Criteria:

1. Signed inform consent
2. Age 18 or greater
3. Elective surgery that requires invasive BP monitoring (A-line)

Exclusion Criteria:

1. Emergency surgery
2. A-line not inserted
3. Informed consent not signed

• Arthur Wallace, MD, PhD, Principal investigator, San Francisco Veterans Affairs Medical Center