Blood Pressure Measurement
Conditions
Brief summary
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
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.
Interventions
Invasive monitoring of blood pressure via catheterization of the radial artery, displaying a continuous pressure waveform and blood pressure values.
PPG fingertip mounted sensor, that measures the oxygen level (oxygen saturation) of the blood and generates a waveform
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.
Sponsors
Sensifree Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed