Data Collection of Arterial Line Waveform and BP Values
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|ClinicalTrials.gov Identifier: NCT04510753|
Recruitment Status : Recruiting
First Posted : August 12, 2020
Last Update Posted : August 12, 2020
|Condition or disease||Intervention/treatment|
|Blood Pressure Measurement||Device: Arterial catheterization kit Device: GE Datex-Ohmeda Finger Clip Pulse Oximeter Sensor Device: NIBP Cuff (GE Healthcare)|
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 Type :||Observational|
|Estimated Enrollment :||100 participants|
|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|
|Actual Study Start Date :||November 22, 2019|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
- 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.
- Comparison of BP values between a PPG sensor based device and an arterial line [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04510753
|Contact: Anusha Badathala, MBBS||4152214810 ext 23732||Anusha.Badathala@ncire.org|
|United States, California|
|San Francisco Veterans Affairs Medical Center||Recruiting|
|San Francisco, California, United States, 94121|
|Contact: Anusha Badathala, MBBS 415-221-4810 ext 22798 Anusha.Badathala@ncire.org|
|Principal Investigator: Arthur Wallace, MD, PhD|
|Principal Investigator:||Arthur Wallace, MD, PhD||San Francisco Veterans Affairs Medical Center|