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

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

• Level of accordance between the Biobeat monitor and the arterial line [Time frame: 4 hours per individual]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

Israel · 1 center

• The Sheba Medical Center, Tel Hashomer — Ramat Gan

Publications

• Hellou E, Jamal T, Zuroff E, Kalhor P, Delgado-Lelievre M, Manzato M, Lerman LO, Lerman A, Kachel E, Zoghby Z. Performance of a cuffless photoplethysmography-based device for continuous monitoring of blood pressure after cardiac surgery: a preliminary validation study. J Hum Hypertens. 2025 Dec;39(12):894-902. doi: 10.1038/s41371-025-01082-w. Epub 2025 Oct 18. PMID 41109863

Identifiers

NCT: NCT04071015 · Biobeat003

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗