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

Comparison of Continuous Non-Invasive Blood Pressure Measurement Using the Wireless Cuffless Biobeat Monitor 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.

Study Overview

• Status: Recruiting
• Conditions: Heart Diseases; Blood Pressure
• Intervention / Treatment: Device: Non-invasive monitoring

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Arik Eisenkraft, MD, MHA; Phone Number: +972-52-9210896; Email: dr.arik@bio-beat.gov
• Study Contact Backup: Name: Arik Ben-Ishay; Phone Number: +972-53-5287768; Email: arik@bio-beat.com

Study Locations

• Israel
  • Ramat Gan, Israel, 526560
    • Recruiting
    • The Sheba Medical Center, Tel Hashomer
    • Contact: Erez Kachel, MD; Phone Number: +972-52-6668274; Email: erezk@bezeqint.net
    • Contact: Ofir Kagan; Phone Number: +972-54-5607132; Email: Ofir.Kagan@sheba.health.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

20 patients immediately after cardiac surgery arriving to the intensive care unit, and connected to an arterial line and or a Swan Ganz catheter transducer. Usually the arterial line is left for 24 hours. Right after arrival and once connected to an arterial line, the participants will be connected to the Biobeat monitor (both wristwatch or a patch). Vital signs will be monitored for 4 hours, and recorded every 15 minutes, for comparison. After 4 hours, the Biobeat monitor will be disconnected.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of accordance between the Biobeat monitor and the arterial line	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.	4 hours per individual

Collaborators and Investigators

• Sponsor: Biobeat Technologies Ltd.
• Collaborators: The Chaim Sheba Medical Center
• Investigators: Principal Investigator: Erez Kachel, MD, The Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2020
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: August 25, 2019
• First Submitted That Met QC Criteria: August 26, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: cardiac surgery; blood pressure; vital signs; non-invasive monitoring
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: Biobeat003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The investigators would probably share the results showing the level of agreement between the two measurement methods, but it will not be an individual data, rather the whole group, without any personal data included.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No