Evaluation of EverOn™ System in Medical / Surgical Ward

NCT00640718 | Withdrawn DMC

• 1 other identifier: ES-MRK-PROT1.1
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

heart and respiratory monitoring

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults hospitalized in medical surgical units and are willing to sign consent form

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• EarlySense Ltd.: lead

Study Sites (1)

MetroWest Medical Center

Framingham, Massachusetts, 01702-9167, United States

Location

Related Links

• Institute for Health Care Improvement (IHI)

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 17, 2008
• First Posted: March 21, 2008
• Study Start: March 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: May 1, 2010
• Last Updated: July 19, 2016

Record last verified: 2008-03

Locations

US (1)