Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04635371
Enrollment
70
Registered
2020-11-19
Start date
2020-11-20
Completion date
2021-06-30
Last updated
2021-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Cardiac Event, Acute Cardiac Failure, Acute Cardiac Pulmonary Edema

Keywords

Acute Catdiac Events; Remote Patient Monitoring

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.

Interventions

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.

Sponsors

Biobeat Technologies Ltd.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Detection of cardio-respiratory changesThrough 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

MeasureTime frameDescription
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.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026