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临床试验/NCT00542854
NCT00542854已完成不适用

A Pilot Study on the Effects of Digital Music Players on Implantable Cardioverter Defibrillators and Pacemakers in Pediatrics and Congenital Heart Disease

Boston Children's Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2007年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Change in pacemaker sensing thresholds, pacing thresholds, telemetry interference or pacemaker inhibition.

研究概览

简要总结

Unlike phones, which are commonly held to the ear, music is now available via portable MP3 players and they can be held almost anywhere. Thaker et al state that Apple iPods cause pacemaker interference in 50% of their patients, with over-sensing in 20% of patients, telemetry interference in 29% of patients and pacemaker inhibition in 1.2% of patients. The mean age for their sample was 76.1 years +/- 8.6 years. We anticipate that a higher proportion of teenagers and children who have pacemakers use portable MP3 players than in the elderly adult population.We will include the first 100 patients with pacemakers and ICDs who consent for the prospective observational study a single tertiary care center. We intend to conduct a descriptive study, tabulating the number of times that a pacemaker or ICD has changes in the sensing thresholds, pacing thresholds, telemetry interference or pacemaker inhibition when exposed to a series of portable MP3 players at various distances. In addition, we will describe the nature and quantitative differences of those changes.

详细描述

Since pacemakers and implantable cardioverter defibrillators (ICDs) have been used, there have been questions about what external sources interference could alter their functioning or event recording properties. Because these devices are often intended to be life-saving, their proper functioning is of critical importance.

The literature documents a number of common sources of possible interference. Interference with MRI and electrocautery have been observed (1, 2). Outside the hospital, store security devices and personal digital assistants (PDAs) have been evaluated (3, 4). In 1997, Hayes et al published a randomized, prospective trial concluding that cellular telephones impacted the functioning of pacemakers, but that they did not seem to have any effect at any significant distance (5). They showed that a phone being used at the ear was sufficiently far away to prevent a health risk and recommended that phones not be put in shirt pockets or used near the device.

Unlike phones, which are commonly held to the ear, music is now available via portable MP3 players and they can be held almost anywhere. Thaker et al state that Apple iPods cause pacemaker interference in 50% of their patients, with over-sensing in 20% of patients, telemetry interference in 29% of patients and pacemaker inhibition in 1.2% of patients (6). The mean age for their sample was 76.1 years +/- 8.6 years. We anticipate that a higher proportion of teenagers and kids who have pacemakers use portable MP3 players than in the elderly adult population.

Design Prospective observational study a single tertiary care center.

Subjects

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

年龄范围
4 Years 至 55 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children and adults with congenital heart disease who have an implanted pacemaker or defibrillator

排除标准

  • Age less than 4 or inability to communicate adequately with study team

结局指标

主要结局

Change in pacemaker sensing thresholds, pacing thresholds, telemetry interference or pacemaker inhibition.

时间窗: 10 minutes

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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