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

NCT04071015 | Recruiting FDA Device

• 1 other identifier: Biobeat003
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Blood Pressure; Heart Diseases

Keywords

vital signs; blood pressure; cardiac surgery; non-invasive monitoring

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Non-invasive monitoring DEVICE

Comparing blood pressure measurement using the Biobeat non-invasive monitor to arterial line.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Biobeat Technologies Ltd.: lead
• The Chaim Sheba Medical Center: collaborator

Study Sites (1)

The Sheba Medical Center, Tel Hashomer

Ramat Gan, 526560, Israel

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Erez Kachel, MD

  The Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arik Eisenkraft, MD, MHA

CONTACT

+972-52-9210896; dr.arik@bio-beat.gov

Arik Ben-Ishay

CONTACT

+972-53-5287768; arik@bio-beat.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2019
• First Posted: August 28, 2019
• Study Start: June 15, 2020
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

IL (1)