Status:

COMPLETED

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

Lead Sponsor:

Sensifree Ltd.

Conditions:

Blood Pressure Measurement

Eligibility:

All Genders

18-80 years

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 ca...

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 u...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

June 19 2018

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

March 31 2021

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT04132453

Start Date

June 19 2018

End Date

March 31 2021

Last Update

June 9 2022

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Wolfson Medical Center

Holon, Israel, 58100