Evaluation of Sensifree's Algorithm for Continuous Blood Pressure Measurements Based on a PPG Sensor's Signal Compared to Invasive Radial Arterial Line
Sponsor study identifier
observational
100
1 country
1
Study Start
November 22, 2019
Actual (reported)Primary Completion
December 9, 2020
Actual (reported)Study Completion
December 9, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 9, 2020
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 22, 2019
Actual (reported)July 29, 2020
Actual (reported)August 12, 2020
Actual (reported)December 9, 2020
Actual (reported)December 9, 2020
Actual (reported)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
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
Patients scheduled for elective surgery involving placement of radial artery A-line for BP monitoring
San Francisco Veterans Affairs Medical Center
San Francisco, California, 94121, United States
Arthur Wallace, MD, PhD
San Francisco Veterans Affairs Medical Center
100 participants (actual enrollment reported by the registry).
First Submitted
July 29, 2020
First Posted
August 12, 2020
Study Start
November 22, 2019
Actual (reported)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.
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Primary Completion
December 9, 2020
Actual (reported)Study Completion
December 9, 2020
Actual (reported)Last Updated
June 7, 2022
Record last verified: 2020-08
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Source: ClinicalTrials.gov.
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