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临床试验/NCT03271619
NCT03271619已完成不适用

Electrical Safety of Rescuers in Contact With Patients During Implanted Cardioverter Defibrillator Discharge

University Hospital Southampton NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2014年2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
25
试验地点
1
主要终点
Surface current during defibrillation

研究概览

简要总结

Patients at risk of developing life-threatening heart rhythms may require the implantation of a small device called a cardioverter-defibrillator (ICD), which constantly monitors the heart rhythm and delivers an electrical shock to the heart when indicated, in order to return the heart back to a normal rhythm. Many thousands of these devices have been implanted and are electrically active in patients who collapse and need resuscitation.

When a patient with an ICD collapses, the device may discharge without warning while a rescuer is performing external chest compressions (cardiac massage). Conventional ICDs placed below the left collar bone typically deliver 35-50 J energy when they discharge, but newer ICDs placed under the skin (S-ICD) alongside the breastbone deliver a larger energy when discharging; typically 50-80J energy.

Rescuers performing external chest compressions on a patient during conventional ICD discharge have reported the sensation of a painful electrical shock and permanent nerve damage. In these situations, rescuers appear to have been exposed to electrical current from the ICD considerably in excess of that which is considered a safe threshold.

Studies of surface current resulting from discharge of conventional ICDs have been reported in excess of 100 mA which is far in excess of the safe 1 mA limit, and puts the rescuer at considerable risk of tissue damage and possible dangerous heart rhythms. The newer S-ICDs deliver approximately 50% more energy and have the potential to result in exposure of a rescuer to even higher currents.

With increasing numbers of the S-ICDs being implanted, and the inevitability that rescuers will soon find themselves exposed to leakage current from these devices, there is a need to examine the leakage currents arising from these devices and assess any subsequent risk to a rescuer performing external chest compressions.

详细描述

Rationale for Study:

When patients undergo elective implantation of an ICD, the device is tested by inducing ventricular fibrillation (VF) in the patient and allowing the ICD to sense, charge and discharge in an attempt to shock the patient back into a normal rhythm. This provides a controlled, elective situation in which to measure the cutaneous current on the patient's skin which is the current to which a rescuer could potentially be exposed.

By understanding the leakage currents from these devices, the investigators will be able to better understand the safety of rescuers in contact with patients fitted with an ICD and make specific recommendations to enable to safe undertaking of uninterrupted external chest compressions while the ICD may be discharging.

STUDY OBJECTIVES

Primary Objective:

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with implanted defibrillators (ICDs) undergoing defibrillation testing
  • Patients undergoing ICD implantation that requires a defibrillation test at the end of the implantation.

排除标准

  • Enrolment in other ICD-related studies
  • Patients <18 yrs age

结局指标

主要结局

Surface current during defibrillation

时间窗: Approximately 10 mSec as the ICD discharges (i.e. at the time of testing)

To measure cutaneous leakage current on the chest wall during conventional and S-ICD discharge.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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