Monitoring Patients With Acute Cardiac Disease Using a Wireless, Wearable, Non-invasive Monitor

July 4, 2021 updated by: Biobeat Technologies Ltd.

Monitoring Patients With Acute Cardiac Disease Using a Wireless, Wearable, Non-invasive PPG-based Monitor in the Cardiac ICU

A prospective observational study in patients admitted with an acute cardiac disease, in which the PPG-based device will be attached to them on admission, for frequent monitoring of their vitals during hospitalization and interventional procedures. in parallel to currently-used and approved devices. Data will be crossed with gathered clinical and laboratory data, to study the device's ability to detect acute hemodynamic and respiratory changes during hospitalization, and gathering workflow information from the nursing staff.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Holon, Israel, 58100
        • The Edith Wolfson Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

200 men and women admitted to the cardiac ICU with acute caridac event.

Description

Inclusion Criteria:

  • Men and women aged 18 years and above admitted to the Cardiac ICU due to an acute cardiac event.

Exclusion Criteria:

  • Pregnant women, subjects under the age of 18 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of cardio-respiratory changes
Time Frame: Through study completion, an average of 1 year.
Detection of acute cardio-respiratory/hemodynamic changes during hospitalization and during interventional procedures conducted in the cardiac ICU.
Through study completion, an average of 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Workflow assessment.
Time Frame: Through study completion, an average of 1 year.
Nursing staff will be asked - using questionnaires - to assess whether the use of these devices helps in reducing burden of work and increase other interactions with the patients.
Through study completion, an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biobeat Technologies Ltd.

Investigators

  • Principal Investigator: Ronen Rubinshtein, MD, The Edith Wolfson Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2020

Primary Completion (Actual)

June 15, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

November 8, 2020

First Submitted That Met QC Criteria

November 12, 2020

First Posted (Actual)

November 19, 2020

Study Record Updates

Last Update Posted (Actual)

July 7, 2021

Last Update Submitted That Met QC Criteria

July 4, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPGCICUWOMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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