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

NCT04635371 | Completed FDA Device

• 1 other identifier: PPGCICUWOMC
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Cardiac Event; Acute Cardiac Failure; Acute Cardiac Pulmonary Edema

Keywords

Acute Catdiac Events; Remote Patient Monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Workflow assessment.

  Through study completion, an average of 1 year.

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Biobeat Technologies Ltd.: lead

Study Sites (1)

The Edith Wolfson Medical Center

Holon, 58100, Israel

Location

Study Officials

• Ronen Rubinshtein, MD

  The Edith Wolfson Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2020
• First Posted: November 19, 2020
• Study Start: November 20, 2020
• Primary Completion: June 15, 2021
• Study Completion: June 30, 2021
• Last Updated: July 7, 2021

Record last verified: 2021-07

Locations

IL (1)