Clinical Comparison of Electrocardiograms Collected Using an Ambulatory Holter (Orbital)

The objective of the study is to compare electrocardiograms using ambulatory holter monitor with dry electrodes in a harness versus using an ambulatory holter with standard sticky electrodes (Red Dot) on monitored patients within the hospital. Patients will be simultaneously be hooked up to two ambulatory Holter monitors for the period of time to be not less than one hour. One holter will use standard electrodes in a standard electrode distribution. The second holter will use dry electrodes in a derived.

Study Overview

• Status: Completed
• Conditions: Electrocardiography
• Intervention / Treatment: Device: Electrocardiogram holter

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Toledo, Ohio, United States, 43606
      • University of Toledo, Health Science Campus

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

All patients within the hospital either for a procedure or for admission

Description

Inclusion Criteria:

• Any patient within the hospital either for procedure or for admission

Exclusion Criteria:

• Patients who cannot wear a Holter monitor
• Patients undergoing an MRI or have other contraindications for wearing an ambulatory Holter monitor.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients with Electrocardiograms; Any patient within the hospital either for procedure or for admission will be screened. Patients will be simultaneously be hooked up to two ambulatory Holter monitors for the period of time to be not less than one hour. One holter will use standard electrodes in a standard electrode distribution. The second holter will use dry electrodes in a derived; data will be collected for 1-6 hours. After the data is collected the Holters will be removed and the data will be downloaded into the reading software to be scanned.

Device: Electrocardiogram holter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arrythmia	quality of data obtained between harness and holter. Subjective evaluation: -Quality of the data will be rated on a 0 - 10 scale with 0 being unreadable and 10 being excellent	15 minutes

Collaborators and Investigators

• Sponsor: University of Toledo Health Science Campus
• Investigators: Principal Investigator: Jennifer Cummings, MD, The University of Toledo

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: March 3, 2015
• First Submitted That Met QC Criteria: March 3, 2015
• First Posted (Estimate): March 9, 2015

Study Record Updates

• Last Update Posted (Actual): October 7, 2019
• Last Update Submitted That Met QC Criteria: September 16, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Orbital