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
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: 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 September 11, 2014