Interference Between Surgical Magnetic Drapes and Pacemakers

Electromagnetic Interference Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02617355
• Other study ID #: 11061
• Status: Completed
• Phase: N/A
• First received: November 24, 2015
• Last updated: November 27, 2015
• Start date: October 2011
• Est. completion date: November 2011

Study information

• Verified date: November 2015
• Source: Maisonneuve-Rosemont Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Electromagnetic Interference

Intervention

Device:
• Prototype surgical magnetic drape
New prototype surgical magnetic drape made with bottom-isolated ferrite magnets applied to the patient's thorax
• Green Covidien Magnetic Drape
Green Covidien Magnetic Drape applied to the patient's thorax
• Jac-Cell Medic Reusable Magnetic Pad
Jaa-Cell Medic Reusable Magnetic Pad applied to the patient's thorax
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Maisonneuve-Rosemont Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes