Evaluation of EverOn™ - A Contact-Free System for Measuring Heart Rate, Respiratory Rate and Motion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
EarlySense Ltd.
ClinicalTrials.gov Identifier:
NCT00875602
First received: April 2, 2009
Last updated: October 11, 2012
Last verified: October 2012
  Purpose

Evaluattion of continuous monitoring device on patients Risk during hospitalization and nurse satisfaction level.


Condition Intervention
Post Surgical Pat., Medical Patients, Respiratory Failure, Cardiac Arrest, Death
Device: EverOn (EarlySense) contactless monitoring device

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of EverOn™ - A Contact-Free System for Measuring Heart Rate, Respiratory Rate and Motion

Resource links provided by NLM:


Further study details as provided by EarlySense Ltd.:

Primary Outcome Measures:
  • Evidence of benefit to caregivers and patients [ Time Frame: 12 month ] [ Designated as safety issue: No ]

Enrollment: 2314
Study Start Date: April 2009
Study Completion Date: September 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control
before-after (retrospective) and concurrent controls as comparators with a prospective intervention group
Active Comparator: Study unit
Hospitalized patients in the study group will be continously monitored / supervised by the contact-free device
Device: EverOn (EarlySense) contactless monitoring device
Hospitalized patients on the study unit are monitored by a contactless device

Detailed Description:

To assess the effects of continuous patient monitoring using a contactless monitor in a medical-surgical unit on transfers and length of stay at higher level of care units

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hospitalized patients

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00875602

Locations
United States, California
CHMC
Los Angeles, California, United States, 90015
Sponsors and Collaborators
EarlySense Ltd.
Investigators
Principal Investigator: Harvey V Brown, MD CHW
  More Information

No publications provided

Responsible Party: EarlySense Ltd.
ClinicalTrials.gov Identifier: NCT00875602     History of Changes
Other Study ID Numbers: CHW ES-MRK-PROT-6
Study First Received: April 2, 2009
Last Updated: October 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by EarlySense Ltd.:
All hospitalized patients in a general Med/ Surg unit

Additional relevant MeSH terms:
Heart Arrest
Respiratory Insufficiency
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014