Monitoring Changes in Blood Pressure

November 30, 2016 updated by: EarlySense Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Holon, Israel
        • Wolfson Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients from 2 groups will be recruited:

  1. 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)
  2. Patients hospitalized in intensive care with arterial line that allow continuous blood pressure measurement

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Internal ward
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)
Passive contact-free monitoring
ICU
Patients hospitalized in intensive care with arterial line that allow continuous blood pressure measurement
Device: EarlySense (Passive monitoring)
Passive contact-free monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EarlySense Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

December 14, 2015

First Submitted That Met QC Criteria

December 28, 2015

First Posted (Estimate)

December 29, 2015

Study Record Updates

Last Update Posted (Estimate)

December 1, 2016

Last Update Submitted That Met QC Criteria

November 30, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ES-CLC-2015_Prot_1_BP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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