Data Collection of Arterial Line Waveform and BP Values

Completed

• Conditions: Blood Pressure Measurement

• Registration Number: NCT04510753
• Lead Sponsor: Sensifree Ltd.

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.

Study Timeline

• Study Start: 2019-11-22
• Study First Submitted: 2020-07-29
• Status Verified: 2020-08
• Study First Submitted QC: 2020-08-10
• Study First Posted: 2020-08-12
• Primary Completion: 2020-12-09
• Study Completion: 2020-12-09
• Last Update Submitted: 2022-06-06
• Last Update Posted: 2022-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

San Francisco Veterans Affairs Medical Center; 🇺🇸 San Francisco, California, United States