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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
Sponsor:
Information provided by (Responsible Party):
Sensifree Ltd.

Study Description
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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.

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)

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 Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Groups and Cohorts
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Intervention Details:
  • 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.

Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled for elective surgery involving placement of radial artery A-line for BP monitoring
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Anusha Badathala, MBBS 4152214810 ext 23732 Anusha.Badathala@ncire.org

Locations
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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         
Sponsors and Collaborators
Sensifree Ltd.
Investigators
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Principal Investigator: Arthur Wallace, MD, PhD San Francisco Veterans Affairs Medical Center
More Information
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Responsible Party: Sensifree Ltd.
ClinicalTrials.gov Identifier: NCT04510753    
Other Study ID Numbers: CLN-30-0054
First Posted: August 12, 2020    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No