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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04220359

Enrollment

410

Registered

2020-01-07

Start date

2020-07-06

Completion date

2021-04-30

Last updated

2021-05-25

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

Conditions

Clinical Deterioration, Hemodynamic Instability

Keywords

vital signs, clinical deterioration, early prediction, non-invasive monitoring

Brief 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.

Interventions

DEVICEnon-invasive monitoring

Prospective monitoring with retrospective big-data analysis

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

Inclusion criteria

* Males and females 18 years old and above admitted to the internal medicine department * On admission, the primary investigator assess their risk to deteriorate during the first 72 hours after admission as reasonably high * The patient is assigned to a monitoring bed within the department * The patient has signed an informed consent form

Exclusion criteria

* Lack of informed consent * It is known in advance that the patient cannot take part in the study for a 72-hours period (e.g. a patient that will be taken to surgery within the next 24 hours) * Technical inability to attach the Biobeat patch (BB-613PW) to the patients chest

Design outcomes

Primary

Measure	Time frame	Description
Monitoring blood pressure changes in high-risk patients	72 hours per individual	The investigators will record blood pressure measurements using a non-invasive wireless monitoring device working continuously for 72 hours in high-risk patients.

Secondary

Measure	Time frame	Description
Monitoring early heart rate changes in high-risk patients	72 hours per individual	The investigators will record heart rate using a non-invasive wireless monitoring device working continuously for 72 hours in high-risk patients.
Monitoring respiratory rate changes in high-risk patients	72 hours per individual	The investigators will record respiratory rate using a non-invasive wireless monitoring device working continuously for 72 hours in high-risk patients.
Monitoring blood oxygen saturation changes in high-risk patients	72 hours per individual	The investigators will record blood oxygen saturation using a non-invasive wireless monitoring device working continuously for 72 hours in high-risk patients.
Monitoring stroke volume changes in high-risk patients	72 hours per individual	The investigators will record stroke volume measurements using a non-invasive wireless monitoring device working continuously for 72 hours in high-risk patients.
Monitoring cardiac output changes in high-risk patients	72 hours per individual	The investigators will record cardiac output measurements using a non-invasive wireless monitoring device working continuously for 72 hours in high-risk patients.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026