The Baruch Padeh Medical Center, Poriya
Tiberias, Lower Galilee, 15208, Israel
NCT Number: NCT03603860
In this clinical study the investigators will compare blood pressure measurements obtained using the non-invasive, continuous and wireless Biobeat monitoring device (a wrist watch or a patch configuration) to an invasive arterial line (radial or femoral) in 30 patients immediately after cardiac surgery, at the intensive care unit.
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Notify Me18 year and older
All sexes
Observational
Tiberias, Lower Galilee, 15208, Israel
The Biobeat non-invasive, continuous and wireless monitoring device is based on photoplethysmograph 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. The study population includes 30 patients undergoing cardiac surgery. As per local protocol, each one of the participants will come out from the operating room with an arterial line. Once in the intensive care unit, the investigators will attach the Biobeat non-invasive monitor (either wrist watch or 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Comparing blood pressure measurement using the Biobeat non-invasive monitor to arterial line
Time frame: 4 hours per individual
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.
Biobeat Technologies Ltd.
Industry
Comparison of Continuous Blood Pressure Measurement Using the Non-invasive, Wireless Biobeat Monitor With an Invasive Arterial Line
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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