Early Identification of Clinical Deterioration Using a Wearable Monitoring Device

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

410 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-06

Study Completion Date

2021-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Clinical Deterioration Hemodynamic Instability

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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non-invasive monitoring

Prospective monitoring with retrospective big-data analysis

Intervention Type DEVICE

Other Intervention Names

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BB-613PW

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No