Clinical trial NCT04071015: Comparison of Non-Invasive Blood Pressure (NIBP) Using the Biobeat Device with an Invasive Arterial Line Catheter
Official title: Comparison of Continuous Non-Invasive Blood Pressure Measurement Using the Wireless Cuffless Biobeat Monitor with an Invasive Arterial Line Catheter
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Blood Pressure
Heart Diseases
Keywords: vital signs
blood pressure
cardiac surgery
non-invasive monitoring
Lead sponsor: Biobeat Technologies Ltd.
Sponsor class: INDUSTRY
Collaborators: name: The Chaim Sheba Medical Center
First posted: 2019-08-28
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20 patients immediately after cardiac surgery arriving to the intensive care unit, and connected to an arterial line and or a Swan Ganz catheter transducer. Usually the arterial line is left for 24 hours. Right after arrival and once connected to an arterial line, the participants will be connected to the Biobeat monitor (both wristwatch or a patch). Vital signs will be monitored for 4 hours, and recorded every 15 minutes, for comparison. After 4 hours, the Biobeat monitor will be disconnected.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Level of accordance between the Biobeat monitor and the arterial line
timeFrame: 4 hours per individual
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: The Sheba Medical Center, Tel Hashomer
Study officials:
affiliation: The Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel
name: Erez Kachel, MD
role: PRINCIPAL_INVESTIGATOR
References: