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

Heart Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04071015
• Other study ID #: Biobeat003
• Status: Recruiting
• Start date: June 15, 2020
• Est. completion date: December 2023

Study information

• Verified date: February 2022
• Source: Biobeat Technologies Ltd.
• Contact: Arik Eisenkraft, MD, MHA
• Phone: +972-52-9210896
• Email: dr.arik[@]bio-beat.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Heart Diseases

Intervention

Device:
• Non-invasive monitoring
Comparing blood pressure measurement using the Biobeat non-invasive monitor to arterial line.

Locations

Country	Name	City	State
Israel	The Sheba Medical Center, Tel Hashomer	Ramat Gan

Sponsors (2)

Lead Sponsor	Collaborator
Biobeat Technologies Ltd.	The Chaim Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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