Comparison of the Non-invasive Biobeat Device With an Invasive Arterial Line

Comparison of Continuous Blood Pressure Measurement Using the Non-invasive, Wireless Biobeat Monitor With an Invasive Arterial Line

In this clinical study the investigators will compare blood pressure measurements obtained using the non-invasive, continuous and wireless Biobeat monitoring device (a wrist watch or a patch configuration) to an invasive arterial line (radial or femoral) in 30 patients immediately after cardiac surgery, at the intensive care unit.

Study Overview

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

Detailed Description

The Biobeat non-invasive, continuous and wireless monitoring device is based on photoplethysmograph 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. The study population includes 30 patients undergoing cardiac surgery. As per local protocol, each one of the participants will come out from the operating room with an arterial line. Once in the intensive care unit, the investigators will attach the Biobeat non-invasive monitor (either wrist watch or 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 (Actual): 18

Contacts and Locations

Study Locations

• Israel
  • Lower Galilee
    • Tiberias, Lower Galilee, Israel, 15208
      • The Baruch Padeh Medical Center, Poriya

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

30 patients immediately after cardiac surgery arriving to the intensive care unit, and connected to an arterial line 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 (either wrist watch 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:

• Patients arriving immediately after cardiac surgery to the intensive care unit with an arterial line.

Exclusion Criteria:

• Refusal to participate
• Patients with no arterial line
• Pregnant women
• Individuals under the age of 18 years
• Patients with lack of judgment/mental illness
• Patients working in the Baruch Padeh Medical Center

Study Plan

How is the study designed?

Design Details

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

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 Baruch Padeh Medical Center, Poriya
• Investigators: Principal Investigator: Erez Kachel, MD, The BARUCH PADEH Medical Center, Poriya, ISRAEL

Publications and helpful links

General Publications

• Kachel E, Constantini K, Nachman D, Carasso S, Littman R, Eisenkraft A, Gepner Y. A Pilot Study of Blood Pressure Monitoring After Cardiac Surgery Using a Wearable, Non-invasive Sensor. Front Med (Lausanne). 2021 Aug 5;8:693926. doi: 10.3389/fmed.2021.693926. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2018
• Primary Completion (Actual): February 5, 2020
• Study Completion (Actual): March 5, 2020

Study Registration Dates

• First Submitted: July 19, 2018
• First Submitted That Met QC Criteria: July 26, 2018
• First Posted (Actual): July 27, 2018

Study Record Updates

• Last Update Posted (Actual): July 9, 2020
• Last Update Submitted That Met QC Criteria: July 8, 2020
• Last Verified: January 1, 2020

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: Biobeat001

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: No