Interference Between Surgical Magnetic Drapes and Pacemakers: An Observational Study Comparing Commercially Available Devices and a New Magnetically Isolated Drape
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 主要终点
- Percentage of magnetic interference
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a pacemaker
- •18 years or older
排除标准
- •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
结局指标
主要结局
Percentage of magnetic interference
时间窗: 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.
次要结局
未报告次要终点
研究者
Valerie Zaphiratos
Clinical associate Professor
Maisonneuve-Rosemont Hospital