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NCT Number: NCT04071015

Comparison of Non-Invasive Blood Pressure (NIBP) Using the Biobeat Device with an Invasive Arterial Line Catheter

In this clinical study the investigators will compare blood pressure measurements obtained using the non-invasive, wireless Biobeat monitoring device (both a wrist watch and a patch configuration) to an invasive arterial line catheter (radial or femoral) and a Swan Ganz Catheter in 20 patients immediately after cardiac surgery, at the cardiac intensive care unit.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

The Biobeat non-invasive, wireless monitoring device is based on reflective photoplethysmograph (PPG) technology. It measures several vital signs, including blood pressure, stroke volume, pulse rate, pulse pressure, heart rate variability, respiratory rate, saturation, cardiac output, cardiac index, and more. The data is transmitted to Biobeat's application (in both Apple and Google Play), and is available on the individual's cellular phone, tablet, or as a full monitoring system in a hospital department. The aim of this study is to compare the Biobeat monitor with the invasive method of blood pressure measurement, an arterial line, and a Swan Ganz catheter for measurements of cardiac output and stroke volume. The study population includes 20 patients undergoing cardiac surgery. As per local protocol, each one of the participants will come out from the operating room with an arterial line, some will also have a Swan Ganz catheter. Once in the intensive care unit, the investigators will attach the Biobeat non-invasive monitor (both a wristwatch and a patch), these two configurations are identical in terms of the monitoring system), and monitor the participants for 4 hours. Though both methods are continuous, the investigators will record the vital signs every 15 minutes during the 4 hours of the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years old and above patients of both sexes arriving immediately after cardiac surgery to the intensive care unit with a radial/femoral arterial line and or a Swan Ganz catheter and in need for blood pressure monitoring.

Exclusion criteria

  • Refusal to participate
  • Patients with no need or no technical capability to have an arterial line
  • Pregnant women
  • Individuals under the age of 18 years
  • Patients with lack of judgment/mental illness
  • Patients working in the Sheba Medical Center

Treatment and study plan

Non-invasive monitoring

Device

Comparing blood pressure measurement using the Biobeat non-invasive monitor to arterial line.

Primary outcomes

  1. Level of accordance between the Biobeat monitor and the arterial line

    Time frame: 4 hours per individual

    Comparing blood pressure measurements of the Biobeat device with those of the arterial line. Both systolic blood pressure and diastolic blood pressure will be assessed during the study period.

Study contacts

Contact information is provided by the study sponsor or research team.

Arik Ben-Ishay

CONTACT

[email protected]

+972-53-5287768

Arik Eisenkraft, MD, MHA

CONTACT

[email protected]

+972-52-9210896

Sponsors and collaborators

Lead sponsor

Biobeat Technologies Ltd.

Industry

Collaborators

  • The Chaim Sheba Medical Center

Registry information

Official study title

Comparison of Continuous Non-Invasive Blood Pressure Measurement Using the Wireless Cuffless Biobeat Monitor with an Invasive Arterial Line Catheter

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Aug 28, 2019
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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