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Evaluation of EverOn™ System in Medical / Surgical Ward

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
EarlySense Ltd.
ClinicalTrials.gov Identifier:
NCT00640718
First received: March 17, 2008
Last updated: July 17, 2016
Last verified: March 2008
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of EarlySense EverOn™ System in Medical / Surgical Ward

Further study details as provided by EarlySense Ltd.:

Enrollment: 0
Study Start Date: March 2008
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adults hospitalized in medical surgical units and are willing to sign consent form
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640718

Locations
United States, Massachusetts
MetroWest Medical Center
Framingham, Massachusetts, United States, 01702-9167
Sponsors and Collaborators
EarlySense Ltd.
  More Information

Additional Information:
Responsible Party: Dalia Argaman, EarlySense Ltd
ClinicalTrials.gov Identifier: NCT00640718     History of Changes
Other Study ID Numbers: ES-MRK-PROT1.1 
Study First Received: March 17, 2008
Last Updated: July 17, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by EarlySense Ltd.:
heart and respiratory monitoring

ClinicalTrials.gov processed this record on September 26, 2016