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OpenTrials
Completed

NCT Number: NCT04635371

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

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.

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Key information

Conditions

Acute Cardiac Event Acute Cardiac Failure Acute Cardiac Pulmonary Edema

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Edith Wolfson Medical Center

Holon, 58100, Israel

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Non-invasive monitoring

Device

Wearable, wireless, non-invasive chest-patch devices will be attached to the patients following recruitment and aigning an informed consent form, and from that moment on, vitals will be collected automatically and analyzed retrospectively.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Biobeat Technologies Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 19, 2020
Registry last updated
Jul 7, 2021

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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