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

NCT04132453 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2022-06-09

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Sensifree Ltd.

    lead INDUSTRY

Principal Investigators

  • Inbal Dabush-Elisha, MD · Wolfson Medical Center

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-19
Primary Completion
2021-03-31
Completion
2021-03-31
FDA Device
Yes

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04132453 on ClinicalTrials.gov