Interference Between Surgical Magnetic Drapes and Pacemakers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Electromagnetic Interference

Intervention / Treatment
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* Device: Prototype surgical magnetic drape
* Device: Green Covidien Magnetic Drape
* Device: Jac-Cell Medic Reusable Magnetic Pad
* Device: DeRoyal Magnetic Pad size 20 x 16
* Device: DeRoyal Magnetic Pad size 10 x 16


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Prototype vs Covidien magnetic drape<br>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<br>* New prototype surgical magnetic drape made with bottom-isolated ferrite magnets applied to the patient's thorax<br>Device: Green Covidien Magnetic Drape<br>* Green Covidien Magnetic Drape applied to the patient's thorax<br>|
| Other: Prototype vs 4 commercial drapes<br>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<br>* New prototype surgical magnetic drape made with bottom-isolated ferrite magnets applied to the patient's thorax<br>Device: Green Covidien Magnetic Drape<br>* Green Covidien Magnetic Drape applied to the patient's thorax<br>Device: Jac-Cell Medic Reusable Magnetic Pad<br>* Jaa-Cell Medic Reusable Magnetic Pad applied to the patient's thorax<br>Device: DeRoyal Magnetic Pad size 20 x 16<br>* Magnetic Instrument Pad #25-002, size 20 x 16, DeRoyal Industries Inc applied to the patient's thorax<br>Device: DeRoyal Magnetic Pad size 10 x 16<br>* Magnetic Instrument Pad #25-001, size 10 x 16, DeRoyal Industries Inc applied to the patient's thorax<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of magnetic interference | 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 |