Interference Between Surgical Magnetic Drapes and Pacemakers

Maisonneuve-Rosemont Hospital

Status: Completed

Conditions: Electromagnetic Interference

Treatments: Device: Green Covidien Magnetic Drape; Device: DeRoyal Magnetic Pad size 10" x 16"; Device: Prototype surgical magnetic drape; Device: DeRoyal Magnetic Pad size 20" x 16"; Device: Jac-Cell Medic Reusable Magnetic Pad

Study type: Interventional

Funder types: Other

Identifiers

NCT02617355

11061

Details and patient eligibility

About

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.

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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47 participants in 2 patient groups

Prototype vs Covidien magnetic drape

Other group

Description:

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

Treatment:

Device: Green Covidien Magnetic Drape

Device: Prototype surgical magnetic drape

Prototype vs 4 commercial drapes

Other group

Description:

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"

Treatment:

Device: DeRoyal Magnetic Pad size 10" x 16"

Device: Green Covidien Magnetic Drape

Device: DeRoyal Magnetic Pad size 20" x 16"

Device: Prototype surgical magnetic drape

Device: Jac-Cell Medic Reusable Magnetic Pad