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Completed

NCT Number: NCT03603860

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Baruch Padeh Medical Center, Poriya

Tiberias, Lower Galilee, 15208, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-invasive monitoring

Device

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

Primary outcomes

  1. Level of accordance between the Biobeat monitor and the 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.

Sponsors and collaborators

Lead sponsor

Biobeat Technologies Ltd.

Industry

Collaborators

  • The Baruch Padeh Medical Center, Poriya

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 27, 2018
Registry last updated
Jul 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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