NCT04071015

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Biobeat Technologies Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Blood Pressure
• Heart Diseases

Interventions

Type	Name	Description
DEVICE	Non-invasive monitoring	Comparing blood pressure measurement using the Biobeat non-invasive monitor to arterial line.

Timeline

• Start date: 2020-06-15
• Primary completion: 2026-11-01
• Completion: 2026-12-01
• First posted: 2019-08-28
• Last updated: 2025-03-26

Locations

1 site across 1 country: Israel

Regulatory

• FDA-regulated device study