Early Identification of Clinical Deterioration Using a Wearable Monitoring Device

Study Overview
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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.

Official Title
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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

Conditions
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Clinical Deterioration, Hemodynamic Instability

Intervention / Treatment
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* Device: non-invasive monitoring


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: non-invasive monitoring|Prospective monitoring with retrospective big-data analysis|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vital signs, clinical deterioration, early prediction, non-invasive monitoring