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

NCT04132453 | Completed FDA Device

• 1 other identifier: CLI-0003.04
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure Measurement

Outcome Measures

Primary Outcomes (1)

• Comparison of waveforms and BP values between PPG sensor and arterial line

  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

  3 months after last patient enrolled

Interventions

Arterial catheterization kit DEVICE

Invasive monitoring of blood pressure via catheterization of the radial artery, displaying a continuous pressure waveform

GE Datex-Ohmeda Finger Clip Pulse Oximeter Sensor DEVICE

PPG based, fingertip mounted sensor, that measures the oxygen level (oxygen saturation) of the blood and generates a waveform

NIBP Cuff (GE Healthcare) DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for elective surgery involving placement of radial artery A-line for BP monitoring

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sensifree Ltd.: lead

Study Sites (1)

Wolfson Medical Center

Holon, 58100, Israel

Location

Study Officials

• Inbal Dabush-Elisha, MD

  Wolfson Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 18, 2019
• Study Start: June 19, 2018
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: June 9, 2022

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)