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Clinical Trials/NCT04220359
NCT04220359
Completed
Not Applicable

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

Biobeat Technologies Ltd.1 site in 1 country410 target enrollmentJuly 6, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Clinical Deterioration
Sponsor
Biobeat Technologies Ltd.
Enrollment
410
Locations
1
Primary Endpoint
Monitoring blood pressure changes in high-risk patients
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 6, 2020
End Date
April 30, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Monitoring blood pressure changes in high-risk patients

Time Frame: 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 Outcomes

  • Monitoring cardiac output changes in high-risk patients(72 hours per individual)
  • Monitoring early heart rate changes in high-risk patients(72 hours per individual)
  • Monitoring stroke volume changes in high-risk patients(72 hours per individual)
  • Monitoring blood oxygen saturation changes in high-risk patients(72 hours per individual)
  • Monitoring respiratory rate changes in high-risk patients(72 hours per individual)

Study Sites (1)

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