Data Collection of Arterial Line Waveform and BP Values

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of Sensifree's Algorithm for Continuous Blood Pressure Measurements Based on a PPG Sensor's Signal Compared to Invasive Radial Arterial Line

Conditions
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Blood Pressure Measurement

Intervention / Treatment
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* Device: Arterial catheterization kit
* Device: GE Datex-Ohmeda Finger Clip Pulse Oximeter Sensor
* Device: NIBP Cuff (GE Healthcare)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed inform consent Age 18 or greater Elective surgery that requires invasive BP monitoring (A-line) Exclusion Criteria: Emergency surgery A-line not inserted Informed consent not signed

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Arterial catheterization kit|Invasive monitoring of blood pressure via catheterization of the radial artery, displaying a continuous pressure waveform and blood pressure values.|
|Device: GE Datex-Ohmeda Finger Clip Pulse Oximeter Sensor|PPG fingertip mounted sensor, that measures the oxygen level (oxygen saturation) of the blood and generates a waveform|
|Device: NIBP Cuff (GE Healthcare)|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |