Evaluation of EverOn™ System in Medical / Surgical Ward

NCT ID: NCT00640718

Last Updated: 2016-07-19

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

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Study Completion Date

2010-05-31

Brief Summary

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The EverOn™ system developed by EarlySense, Ltd., the sponsor of this study, is intended to assist hospitals to better address and improve recognition and response to changes in a patient's condition.

The system, monitors the patient while in bed consists of a contact-free sensor that is placed under the bed mattress and identifies respiratory and heart rates, degree of patient's movement or agitation while in bed as well as patient's actual exit out of the bed. The EverOn system does not require a physical contact with the patient, eliminating the need for any direct contact electrodes, leads, cuffs or nasal cannulae.

Detailed Description

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Conditions

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Post Operative Patient Patients Requiring PCA Respiratory Patients Patients in Risk of Fall

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Age above 18 years.
2. Patients not monitored continuously by telemetry, vital sign monitor or oximetry.
3. Patients not requiring special mattresses (e.g. airflow).
4. The patient or a legal guardian is ready to sign the Informed Consent.

Exclusion Criteria

1. Patients that at the judgment of the staff in the evaluating unit, are not able to communicate coherently and respond to nurses' questions.
2. Patients monitored continuously by telemetry, vital sign monitor or oximetry.
3. Patients requiring special mattresses.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 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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EarlySense Ltd

Locations

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MetroWest Medical Center

Framingham, Massachusetts, United States

Site Status

Countries

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United States

Related Links

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http://www.ihi.org/ihi

Institute for Health Care Improvement (IHI)

Other Identifiers

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ES-MRK-PROT1.1

Identifier Type: -

Identifier Source: org_study_id

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