Interference Between Surgical Magnetic Drapes and Pacemakers

Not Applicable

Completed

• Conditions: Electromagnetic Interference
• Interventions: 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"

• Registration Number: NCT02617355
• Lead Sponsor: Maisonneuve-Rosemont Hospital

Brief Summary

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

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 Timeline

• Study Start: 2011-10
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2015-11
• Study First Submitted: 2015-11-24
• Study First Submitted QC: 2015-11-27
• Last Update Submitted: 2015-11-27
• Study First Posted: 2015-11-30
• Last Update Posted: 2015-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prototype vs Covidien magnetic drape	Green Covidien Magnetic Drape	New prototype surgical magnetic drape made with bottom-isolated ferrite magnets applied to the patient's thorax vs Covidien magnetic drape
Prototype vs 4 commercial drapes	DeRoyal Magnetic Pad size 20" x 16"	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"
Prototype vs Covidien magnetic drape	Prototype surgical magnetic drape	New prototype surgical magnetic drape made with bottom-isolated ferrite magnets applied to the patient's thorax vs Covidien magnetic drape
Prototype vs 4 commercial drapes	Green Covidien Magnetic Drape	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"
Prototype vs 4 commercial drapes	Prototype surgical magnetic drape	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"
Prototype vs 4 commercial drapes	Jac-Cell Medic Reusable Magnetic Pad	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"
Prototype vs 4 commercial drapes	DeRoyal Magnetic Pad size 10" x 16"	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"

Primary Outcome Measures

Name	Time	Method
Percentage of magnetic interference	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.