Interference Between Surgical Magnetic Drapes and Pacemakers

November 27, 2015 updated by: Valerie Zaphiratos, Maisonneuve-Rosemont Hospital

Interference Between Surgical Magnetic Drapes and Pacemakers: An Observational Study Comparing Commercially Available Devices and a New Magnetically Isolated Drape

This study is designed to compare a new prototype surgical magnetic drape made with bottom-isolated ferrite magnets to 4 commercially available surgical magnetic drapes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Magnetic fields may potentially interfere with the function of cardiovascular implantable electronic devices. Sterile magnetic drapes used to hold surgical instruments are often placed on the patient's thorax, and they are likely to interfere with the function of these devices.

This study compares the magnetic interference of a new prototype surgical magnetic drape made with bottom-isolated ferrite magnets to the Covidien magnetic drape and 3 other commercially available surgical magnetic drapes.

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with a pacemaker
  • 18 years or older

Exclusion Criteria:

  • Patients with implantable cardioverter-defibrillator (ICD)
  • Patients in whom the magnet rate cardiac rhythm is indistinguishable from their baseline rhythm
  • Refusal/Inability to consent
  • Language other than French or English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Prototype vs Covidien magnetic drape
New prototype surgical magnetic drape made with bottom-isolated ferrite magnets applied to the patient's thorax vs Covidien magnetic drape
Device: Prototype surgical magnetic drape
New prototype surgical magnetic drape made with bottom-isolated ferrite magnets applied to the patient's thorax
Device: Green Covidien Magnetic Drape
Green Covidien Magnetic Drape applied to the patient's thorax
OTHER: Prototype vs 4 commercial drapes

New prototype surgical magnetic drape made with bottom-isolated ferrite magnets applied to the patient's thorax vs 4 commercially available magnetic drapes:

Green Covidien Magnetic Drape Jac-Cell Medic Reusable Magnetic Pad DeRoyal Magnetic Pad size 10" x 16" DeRoyal Magnetic Pad size 20" x 16"
Device: Prototype surgical magnetic drape
New prototype surgical magnetic drape made with bottom-isolated ferrite magnets applied to the patient's thorax
Device: Green Covidien Magnetic Drape
Green Covidien Magnetic Drape applied to the patient's thorax
Device: Jac-Cell Medic Reusable Magnetic Pad
Jaa-Cell Medic Reusable Magnetic Pad applied to the patient's thorax
Device: DeRoyal Magnetic Pad size 20" x 16"
Magnetic Instrument Pad #25-002, size 20" x 16", DeRoyal Industries Inc applied to the patient's thorax
Device: DeRoyal Magnetic Pad size 10" x 16"
Magnetic Instrument Pad #25-001, size 10" x 16", DeRoyal Industries Inc applied to the patient's thorax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of magnetic interference
Time Frame: Within 2 minutes after placement of surgical magnetic drape to the patient's chest

Percentage of patients experiencing magnetic interference with the application of each surgical magnetic drape.

Magnetic interference defined as a cardiac rhythm change to asynchronous and identical to that produced by a round magnet rhythm over the pacemaker.
Within 2 minutes after placement of surgical magnetic drape to the patient's chest

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maisonneuve-Rosemont Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ACTUAL)

November 1, 2011

Study Completion (ACTUAL)

November 1, 2011

Study Registration Dates

First Submitted

November 24, 2015

First Submitted That Met QC Criteria

November 27, 2015

First Posted (ESTIMATE)

November 30, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

November 30, 2015

Last Update Submitted That Met QC Criteria

November 27, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 11061

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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