PhysioGlove Versus Clinic Electrocardiogram Comparison (CommwellPG)

Reliability of Outpatient Electrocardiogram Recordings in Patients Refered for a Cardiology Consultation

Comparison of the quality of the outpatient clinic electrocardiogram performed on patients sent to a cardiology consultation with a standard cable and the PhysioGlove-ES electrocardiograms performed in the cardiology clinic.

Study Overview

• Status: Unknown
• Conditions: Patients With Normal ECG; Patients With Pathological ECG

Detailed Description

The correct performance of a 12 lead electrocardiogram depends on the correct placement of the electrocardiogram electrodes in internationally agreed upon anatomic locations on the patient's limbs and chest. This process requires specific training and diligence on the part of the electrocardiogram performer. The literature points towards a progressive quality degradation of the electrocardiogram performance probably due to the delegation of it's performance to lesser trained individuals. This study is attempting to ascertain the quality of the electrocardiogram recordings performed in non-specialized out patient clinics.

For this purpose we will compare outpatient electrocardiograms of patients referred to a cardiological consultation with electrocardiogram's acquired using a conventional electrocardiogram cable as well as the PhysioGlove-ES by the well training cardiology clinic personnel.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Israel
  • Natanya, Israel
    • Clalit- Cardiology consult clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult male and female patients

Description

Inclusion Criteria: all consenting male and female patients age 18-95 -

Exclusion Criteria:

1. All patients using shirt-sizes under small mand over extra-large
2. all patients with severe chest malformations or open wounds or contagious skin infections involving the chest and/or arms -

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the technical and diagnostic quality of outpatient clinic electrocardiogram with the on-site (cardiology consultation clinic) performed electrocardiograms	The cardiology clinic electrocardiogram will be compared to the out-patient electrocardiogram brought by the patient to the cardiology consultant	Each patient will be tested once while visiting the cardiology consultation clinic. No further patient follow-up is planed. Data collection and evaluation is estimated at 6-9 months from study initiation

Collaborators and Investigators

• Sponsor: Meir Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Anticipated): November 1, 2011
• Study Completion (Anticipated): March 1, 2012

Study Registration Dates

• First Submitted: July 24, 2011
• First Submitted That Met QC Criteria: July 31, 2011
• First Posted (Estimate): August 2, 2011

Study Record Updates

• Last Update Posted (Estimate): August 2, 2011
• Last Update Submitted That Met QC Criteria: July 31, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Other Study ID Numbers: Commwell PG 101