Comparison of a Novel 12-Lead Wireless Electrocardiogram (ECG) and a Standard Wired ECG

This study has been completed.
Sponsor:
Collaborator:
Oklahoma State University Center for Health Sciences
Information provided by:
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00998842
First received: October 20, 2009
Last updated: November 3, 2009
Last verified: October 2009
  Purpose

To determine if there is a difference between wireless ECG and wired ECG findings.


Condition Intervention
Healthy
Device: Recom Model 100
Device: GE 5000 ECG Monitor System

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of a Novel 12-Lead Wireless ECG and a Standard Wired ECG

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • ECG recordings from the wireless system will be equivalent to recordings from the standard wired system. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: October 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
healthy subjects
five male, five female, ages 18-64
Device: Recom Model 100
Battery Operated, Ambulatory, Digital Wireless ECG Monitor System
Device: GE 5000 ECG Monitor System
Wired ECG system

Detailed Description:

The aim of the study is to compare ECG recordings from the Signalife Fidelity 100 Wireless 12-lead ECG Monitor System to that of the GE 5000 Wired 12-lead ECG Monitor System during rest and while walking. We hypothesize that ECG recordings from the wireless system will be equivalent to recordings from the standard wired system.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy individuals Age 18-64

Criteria

Inclusion Criteria:

  • Healthy individuals, AND
  • Age 18-64

Exclusion Criteria:

  • Pregnant women,
  • Prisoners,
  • Have known cardiovascular disease, OR
  • Do not pass the PAR-Q and/or show baseline ECG abnormalities.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00998842

Locations
United States, Oklahoma
Family Medicine Clinic
Tulsa, Oklahoma, United States, 74120
Sponsors and Collaborators
University of Oklahoma
Oklahoma State University Center for Health Sciences
  More Information

No publications provided

Responsible Party: Thomas Allen, DO, University of Oklahoma
ClinicalTrials.gov Identifier: NCT00998842     History of Changes
Other Study ID Numbers: OU IRB 14853
Study First Received: October 20, 2009
Last Updated: November 3, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Oklahoma:
ECG
EKG
healthy subjects
electrocardiography, ambulatory

ClinicalTrials.gov processed this record on April 17, 2014