Protocol for Evaluation of EarlySense: A Contact-less Device for Monitoring Changes in Blood Pressure
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Blood Pressure
- Sponsor
- EarlySense Ltd.
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Evaluate accuracy: Blood pressure measured by the EarlySense system in comparison with Gold Standard Devices
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Evaluate accuracy: Blood pressure measured by the EarlySense system in comparison with Gold Standard Devices
Time Frame: 3 months
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