NCT04220359

Early Identification of Clinical Deterioration Using a Wearable Monitoring Device

Early Identification of Hospitalized Patients at High-risk for Clinical Deterioration During the First 72-hours in an Internal Medicine Department. A Prospective, Continuous, Physiologic Big-data-analysis Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 410 (actual)
• Sponsor: Biobeat Technologies Ltd. · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This study aims to provide myriad of physiological parameters in patients admitted in an internal medicine department, and which are defined as being in an increased risk of clinical deterioration within the first 72-hours after admission. The investigators will also conduct a retrospective comparison between physiological changes in patients who did deteriorate to those who did not. This will form the basis for the development of an algorithm for early prediction and warning of physiological and clinical deterioration during the first 72-hours of admission.

Conditions

• Clinical Deterioration
• Hemodynamic Instability

Interventions

Type	Name	Description
DEVICE	non-invasive monitoring	Prospective monitoring with retrospective big-data analysis

Timeline

• Start date: 2020-07-06
• Primary completion: 2021-04-15
• Completion: 2021-04-30
• First posted: 2020-01-07
• Last updated: 2021-05-25

Locations

1 site across 1 country: Israel

Regulatory

• FDA-regulated device study