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Monitoring Changes in Blood Pressure

NCT ID: NCT02641327

Last Updated: 2016-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-11-30

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.

Conditions

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Blood Pressure

Keywords

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Inhospital patients

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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)

EarlySense (Passive monitoring)

Intervention Type DEVICE

Passive contact-free monitoring

ICU

Patients hospitalized in intensive care with arterial line that allow continuous blood pressure measurement

EarlySense (Passive monitoring)

Intervention Type DEVICE

Passive contact-free monitoring

Interventions

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EarlySense (Passive monitoring)

Passive contact-free monitoring

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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EarlySense Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Wolfson Hospital

Holon, , Israel

Site Status

Countries

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Israel

Other Identifiers

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ES-CLC-2015_Prot_1_BP

Identifier Type: -

Identifier Source: org_study_id