Monitoring Changes in Blood Pressure

Completed

• Conditions: Blood Pressure
• Interventions: Device: EarlySense (Passive monitoring)

• Registration Number: NCT02641327
• Lead Sponsor: EarlySense Ltd.

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.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-14
• Study First Submitted QC: 2015-12-28
• Study First Posted: 2015-12-29
• Status Verified: 2016-09
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Last Update Submitted: 2016-11-30
• Last Update Posted: 2016-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Age 18 years and up
2. Patients hospitalized that require stabilization of his/ her blood Pressure
3. Is willing to sign the consent form.

Group II: Patients hospitalized in Intensive Care

1. Age 18 years and up in intensive care with arterial line that allows invasive Blood Pressure measurements
2. Patient or next of kin or legal guardian are willing to sign consent form

Exclusion Criteria

1. Age < 18 years
2. Does not sleep on a mattress that allows placing EarlySense sensor under it
3. Patient or next of kin or legal guardian is not willing to sign consent form

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICU	EarlySense (Passive monitoring)	Patients hospitalized in intensive care with arterial line that allow continuous blood pressure measurement
Internal ward	EarlySense (Passive monitoring)	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)

Primary Outcome Measures

Name	Time	Method
Evaluate accuracy: Blood pressure measured by the EarlySense system in comparison with Gold Standard Devices	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

Trial Locations

Locations (1)

Wolfson Hospital; 🇮🇱 Holon, Israel