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.