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Completed

NCT Number: NCT02617355

Interference Between Surgical Magnetic Drapes and Pacemakers

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.

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Key information

Conditions

Electromagnetic Interference

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prototype surgical magnetic drape

Device

New prototype surgical magnetic drape made with bottom-isolated ferrite magnets applied to the patient's thorax

Green Covidien Magnetic Drape

Device

Green Covidien Magnetic Drape applied to the patient's thorax

Jac-Cell Medic Reusable Magnetic Pad

Device

Jaa-Cell Medic Reusable Magnetic Pad applied to the patient's thorax

DeRoyal Magnetic Pad size 20" x 16"

Device

Magnetic Instrument Pad #25-002, size 20" x 16", DeRoyal Industries Inc applied to the patient's thorax

DeRoyal Magnetic Pad size 10" x 16"

Device

Magnetic Instrument Pad #25-001, size 10" x 16", DeRoyal Industries Inc applied to the patient's thorax

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Maisonneuve-Rosemont Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Nov 30, 2015
Registry last updated
Nov 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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