Monitoring Changes in Blood Pressure

Study Overview
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Brief Summary
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The study objective is to assess the accuracy of Earlysense contactless monitoring to detect changes in blood pressure vs. Gold reference method / devices including ambulatory blood pressure monitoring device (ABPM) or invasive blood pressure monitoring for patients who have arterial line as part of their standard clinical care.

Detailed Description
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The study objective is to collect data to assess the accuracy and reliability of Earlysense contactless monitoring for blood pressure monitoring vs. gold reference methods such as ABPM (Ambulatory blood pressure measurement) for patients hospitalized in Internal Medicine department and vs. Arterial Line measurements for patients hospitalized in ICU. In addition the collected data will be used to further enhance and improve the existing algorithms.

Official Title
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Protocol for Evaluation of EarlySense: A Contact-less Device for Monitoring Changes in Blood Pressure

Conditions
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Blood Pressure

Intervention / Treatment
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* Device: EarlySense (Passive monitoring)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years and up Patients hospitalized that require stabilization of his/ her blood Pressure Is willing to sign the consent form. Group II: Patients hospitalized in Intensive Care Age 18 years and up in intensive care with arterial line that allows invasive Blood Pressure measurements Patient or next of kin or legal guardian are willing to sign consent form Exclusion Criteria: Age < 18 years Does not sleep on a mattress that allows placing EarlySense sensor under it Patient or next of kin or legal guardian is not willing to sign consent form

Ages Eligible for Study
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Minimum Age: 18 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Internal ward<br>Patients hospitalized in Internal Medicine unit with unstable blood pressure that need regulation/ stabilization of their blood pressure (e.g., CHF, post surgical, hypotension or Hypertension patients, patients with kidney failure, heart disease, stroke) | Device: EarlySense (Passive monitoring)<br>* Passive contact-free monitoring<br>|
| ICU<br>Patients hospitalized in intensive care with arterial line that allow continuous blood pressure measurement | Device: EarlySense (Passive monitoring)<br>* Passive contact-free monitoring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate accuracy: Blood pressure measured by the EarlySense system in comparison with Gold Standard Devices | Determine the accuracy of the EarlySense system to measure blood pressure in a contactless way: we would like to see what were the BP measurements in the Gold Standard Devices, compares to what the EarlySense System was measuring at the same time | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inhospital patients