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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1
Wolfson Medical Center
Holon, Israel, 58100