Comparison of the Non-invasive Biobeat Device With an Invasive Arterial Line

Heart Diseases Clinical Trial

Official title:

Comparison of Continuous Blood Pressure Measurement Using the Non-invasive, Wireless Biobeat Monitor With an Invasive Arterial Line

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03603860
• Other study ID #: Biobeat001
• Status: Completed
• Start date: November 5, 2018
• Est. completion date: March 5, 2020

Study information

• Verified date: January 2020
• Source: Biobeat Technologies Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 5, 2020
• Est. primary completion date: February 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients arriving immediately after cardiac surgery to the intensive care unit with an arterial line.

Exclusion Criteria:

• Refusal to participate

• Patients with no arterial line

• Pregnant women

• Individuals under the age of 18 years

• Patients with lack of judgment/mental illness

• Patients working in the Baruch Padeh Medical Center

Related Conditions & MeSH terms

• Blood Pressure
• Heart Diseases

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 Baruch Padeh Medical Center, Poriya	Tiberias	Lower Galilee

Sponsors (2)

Lead Sponsor	Collaborator
Biobeat Technologies Ltd.	The Baruch Padeh Medical Center, Poriya

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