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

NCT03603860 | Completed

• 1 other identifier: Biobeat001
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Blood Pressure; Heart Diseases

Keywords

vital signs; blood pressure; cardiac surgery; non-invasive monitoring

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Non-invasive monitoring DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

30 patients immediately after cardiac surgery arriving to the intensive care unit, and connected to an arterial line 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 (either wrist watch 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biobeat Technologies Ltd.: lead
• The Baruch Padeh Medical Center, Poriya: collaborator

Study Sites (1)

The Baruch Padeh Medical Center, Poriya

Tiberias, Lower Galilee, 15208, Israel

Location

Related Publications (2)

• Eisenkraft A, Goldstein N, Ben Ishay A, Fons M, Tabi M, Sherman AD, Merin R, Nachman D. Clinical validation of a wearable respiratory rate device: A brief report. Chron Respir Dis. 2023 Jan-Dec;20:14799731231198865. doi: 10.1177/14799731231198865.

  PMID: 37612250 DERIVED

• Kachel E, Constantini K, Nachman D, Carasso S, Littman R, Eisenkraft A, Gepner Y. A Pilot Study of Blood Pressure Monitoring After Cardiac Surgery Using a Wearable, Non-invasive Sensor. Front Med (Lausanne). 2021 Aug 5;8:693926. doi: 10.3389/fmed.2021.693926. eCollection 2021.

  PMID: 34422859 DERIVED

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Erez Kachel, MD

  The Baruch Padeh Medical Center, Poriya, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: July 27, 2018
• Study Start: November 5, 2018
• Primary Completion: February 5, 2020
• Study Completion: March 5, 2020
• Last Updated: July 9, 2020

Record last verified: 2020-01

Locations

IL (1)