Data Collection of Arterial Line Waveform and BP Values

Blood Pressure Measurement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04510753
• Other study ID #: CLN-30-0054
• Status: Completed
• Start date: November 22, 2019
• Est. completion date: December 9, 2020

Study information

• Verified date: August 2020
• Source: Sensifree Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 9, 2020
• Est. primary completion date: December 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure Measurement

Intervention

Device:
• Arterial catheterization kit
Invasive monitoring of blood pressure via catheterization of the radial artery, displaying a continuous pressure waveform and blood pressure values.
• 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
• 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.

Locations

Country	Name	City	State
United States	San Francisco Veterans Affairs Medical Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Sensifree Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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