Data Collection of Arterial Line Waveform and BP Values

Sensifree

Status: Completed

Conditions: Blood Pressure Measurement

Treatments: Device: GE Datex-Ohmeda Finger Clip Pulse Oximeter Sensor; Device: Arterial catheterization kit; Device: NIBP Cuff (GE Healthcare)

Study type: Observational

Funder types: Industry

Identifiers

NCT04510753

CLN-30-0054

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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