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

Completed

• Conditions: Acute Cardiac Pulmonary Edema; Acute Cardiac Event; Acute Cardiac Failure

• Registration Number: NCT04635371
• Lead Sponsor: Biobeat Technologies Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-08
• Study First Submitted QC: 2020-11-12
• Study First Posted: 2020-11-19
• Study Start: 2020-11-20
• Primary Completion: 2021-06-15
• Study Completion: 2021-06-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-04
• Last Update Posted: 2021-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection of cardio-respiratory changes	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 Outcome Measures

Name	Time	Method
Workflow assessment.	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.

Trial Locations

Locations (1)

The Edith Wolfson Medical Center; 🇮🇱 Holon, Israel