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Continuous Blood Pressure and Waveform Measurements Comparison Between Invasive Arterial Line and PPG Sensor

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ClinicalTrials.gov Identifier: NCT04132453
Recruitment Status : Recruiting
First Posted : October 18, 2019
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
Sensifree Ltd.

Brief Summary:
The purpose of this study is to compare blood pressure values (systolic, diastolic, mean arterial pressure) and waveform as recorded by a radial arterial line catheter to the waveform and values as calculated by the Sensifree's algorithm from a PPG sensor from a variety group of patients during elective surgeries.

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:

Before induction of anesthesia, an arterial line will be inserted to the patient radial artery using a designated short, stiff tubing kit according to catheter IFU (Instructions for Use), preferably under US guidance. Removal of air bubbles from the catheter-transducer system is mandatory prior to connecting the tubing to the catheter.

Study nurse will connect a Sensifree laptop with designated data acquisition software (Medicollector BEDSIDE) to the multi-parameter monitor communication port and start the recording of invasive blood pressure and pulse oximeter pleth (PPG sensor) per software IFU. Prior to connecting the arterial line system to the patient, a calibration (flush test) will be done and recorded. During the study, any deterioration in the waveform recorded by the intra-arterial catheter will be noted and appropriate corrective measures will be taken as soon as possible (e.g., flushing or adjusting the position of the catheter).

Preferable NIBP (Non Invasive Blood Pressure) measurement rate will be every 10 minutes, unless the medical procedure requires otherwise.

Calibration procedure will be repeated every 60 +/- 5 minutes and at the end of the surgery. Recording will take place for the duration of the surgery.

NIBP cuff will be placed over the arterial-line arm, NIBP air hose will be replaced with an air hose supplied by Sensifree and the pressure gauge in it will be connected to Sensifree laptop via analog to digital converter in order to capture the data.

Medication used during the surgery will be listed and documented in the CRF (Case Report Form) including drugs name, dose, time and method of administration.

Offline data analysis will compare the blood pressure values as calculated by the Sensifree's algorithm based on the PPG signal, to the values obtained from the arterial line. The comparison results will be measured against the accuracy performance requirements per ISO 81060-2.

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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 : June 19, 2018
Estimated Primary Completion Date : January 5, 2020
Estimated Study Completion Date : January 5, 2020

Intervention Details:
  • Device: Arterial catheterization kit
    Invasive monitoring of blood pressure via catheterization of the radial artery, displaying a continuous pressure waveform
  • Device: GE Datex-Ohmeda Finger Clip Pulse Oximeter Sensor
    PPG based, 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.


Primary Outcome Measures :
  1. Comparison of waveforms and BP values between PPG sensor and arterial line [ Time Frame: 3 months after last patient enrolled ]
    Blood pressure waveform will be acquired from the PPG while blood pressure waveform and values (systolic, diastolic, mean) will be acquired from A-line. PPG data will be analyzed by the Sensifree's algorithm and compared to the A-line measurement results according to ISO 81060-2 accuracy specifications



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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:

  • Signed inform consent
  • Age 18-20
  • Elective surgery that requires invasive BP monitoring (A-line)

Exclusion Criteria:

  • Emergency surgery
  • Subject has a condition that might prevent BP fluctuations
  • Subject is taking medicine that might prevent BP fluctuations
  • Arterial line not placed in the radial artery
  • Flush test has inadequate frequency response pre-trial
  • Subject's arterial line contralateral hand is not available for PPG sensor placement
  • Subject has 50% or more pacemaker dependency

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): NCT04132453


Contacts
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Contact: Inbal Dabush-Elisha, MD 972547401116 amarilisbell@gmail.com
Contact: Michal De-Wolff 97235028346 michald@wmc.gov.il

Locations
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Israel
Wolfson Medical Center Recruiting
Holon, Israel, 58100
Contact: Michal De-Wolff    97235028346    michald@wmc.gov.il   
Principal Investigator: Inbal Dabush Elisha, MD         
Sponsors and Collaborators
Sensifree Ltd.
Investigators
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Principal Investigator: Inbal Dabush-Elisha, MD Wolfson Medical Center

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Responsible Party: Sensifree Ltd.
ClinicalTrials.gov Identifier: NCT04132453    
Other Study ID Numbers: CLI-0003.04
First Posted: October 18, 2019    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019
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
Product Manufactured in and Exported from the U.S.: No