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

Acute Cardiac Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04635371
• Other study ID #: PPGCICUWOMC
• Status: Completed
• Start date: November 20, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: July 2021
• Source: Biobeat Technologies Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 30, 2021
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Cardiac Event
• Acute Cardiac Failure
• Acute Cardiac Pulmonary Edema
• Heart Diseases
• Heart Failure
• Pulmonary Edema

Intervention

Device:
• Non-invasive Monitoring
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.

Locations

Country	Name	City	State
Israel	The Edith Wolfson Medical Center	Holon

Sponsors (1)

Lead Sponsor	Collaborator
Biobeat Technologies Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of cardio-respiratory changes	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	Workflow assessment.	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.