NCT04510753

Data Collection of Arterial Line Waveform and BP Values

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Sensifree Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Blood Pressure Measurement

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-11-22
• Primary completion: 2020-12-09
• Completion: 2020-12-09
• First posted: 2020-08-12
• Last updated: 2022-06-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study