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临床试验/NCT01572246
NCT01572246已完成不适用

Effects of Surgical Monopolar Electrocautery and Optimal Electrosurgery Unit Return Pad Placement on Implantable Cardioverter Defibrillators Protocol

Oregon Health and Science University1 个研究点 分布在 1 个国家目标入组 167 人开始时间: 2012年5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
167
试验地点
1
主要终点
Incidence of electromagnetic interference (EMI)

研究概览

简要总结

This observational protocol will evaluate the effects of monopolar electrocautery (ME) on implantable cardioverter defibrillators (ICDs) in patients undergoing surgery. ME can cause electromagnetic interference (EMI) leading to ICD damage or inadvertent ICD discharge (shocks). Recommended practice calls for the preoperative reprogramming of ICDs when ME will be used to prevent patients from receiving inadvertent shocks. This requires the presence of someone trained in ICD programming, but a trained person is not always readily available.

In this study the investigators will reprogram ICDs prior to surgery according to current practice, but will also record what would have happened had the ICD reprogramming not occurred ("detection on" but "therapy off"). In addition, the investigators will evaluate the effect of the location of the electrosurgery unit (ESU) return pad on the incidence of EMI. The investigators hypothesize that directing the current return path away from the ICD will result in lower EMI rates than previously described.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult individuals of both genders, 18 years of age and older
  • For patients undergoing surgery about the waist, previous implantation of a functioning Boston Scientific or Medtronic ICD
  • For patients undergoing surgery below the waist, previous implantation of a functioning Boston Scientific, Medtronic, St. Jude Medical, or Biotronik ICD
  • Signed informed consent

排除标准

  • Surgery involving the ICD pocket (generator change out procedure)
  • Surgery or procedures exclusively involving bipolar electrocautery (such as ophthalmic surgery)
  • Patients undergoing surgery above the waist with ICDs not manufactured by Medtronic or Boston Scientific (other ICDs do not allow reprogramming to allow EMI detection without the potential for inadvertent ICD discharge)

结局指标

主要结局

Incidence of electromagnetic interference (EMI)

时间窗: During surgery on day of enrollment

Evaluation of occurence of EMI when monopolar electrocautery is used in surgical procedures when the patient has an existing ICD.

次要结局

  • Incidence of unexpected preoperative ICD-related problems(Up to 6 months prior to date of surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter Schulman

Assistant Professor

Oregon Health and Science University

研究点 (1)

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