Evaluation of EverOn™ System in Medical / Surgical Ward

Respiratory Patients Clinical Trial

Official title:

Evaluation of EarlySense EverOn™ System in Medical / Surgical Ward

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00640718
• Other study ID #: ES-MRK-PROT1.1
• Status: Withdrawn
• Phase: N/A
• First received: March 17, 2008
• Last updated: July 17, 2016
• Start date: March 2008
• Est. completion date: May 2010

Study information

• Verified date: March 2008
• Source: EarlySense Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2010
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	MetroWest Medical Center	Framingham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
EarlySense Ltd.

Country where clinical trial is conducted

United States, 

External Links

•   Institute for Health Care Improvement (IHI)