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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04071015
Other study ID # Biobeat003
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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