跳至主要内容
临床试验/NCT01824212
NCT01824212已完成不适用

Recognizing Ventricular Fibrillation From an Area of a Mobile Phone

North Karelia Central Hospital2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2013年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22
试验地点
2
主要终点
The ability of AED to recognise induced VF

研究概览

简要总结

Recognition of out of hospital cardiac arrest (OHCA) during an emergency call is based on standardized questions concerning the symptoms of OHCA. With this method cardiac arrest is recognized in 50-83% of cases. When the emergency medical dispatcher identifies cardiac arrest during the emergency call the survival of the patient improves. Accurate emergency medical service response is activated promptly and bystander will receive cardiopulmonary resuscitation (CPR) instructions. It has been estimated that proper implementation of CPR instructions will save thousands of lives each year.

If the ECG could be recorded by the mobile phone, transmitted during the emergency call to the dispatch centre and analysed there with the software of a semi-automated external defibrillator(AED), the recognition of cardiac arrest could be more accurate.

The aim of this study is to examine, if AED, with minimal size electrodes within an area of a mobile phone, is able to recognize reliably ventricular fibrillation (VF), the rhythm with the best prognosis in OHCA.

详细描述

Dysrhythmia patients who need an implantable cardioverter defibrillator(ICD) or patients with an already implanted ICD which function needs to be revised will be recruited into this study. Our hypothesis is that the ECG and VF is recordable in 100% of cases with a semi-automatic defibrillator. In sample size calculations we compared this 100% recognition to the present situation with 80% recognition of cardiac arrest in emergency medical communication centre during emergency call. According to the power calculation of 1-sided binomial test with risk level 0.05 and power of 95 %, 22 observations is needed to detect difference between expected full successes (99 %) from the previous 80 % of successes in recognition.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • age over 18
  • ventricular fibrillation will be induced during the implantation or revision of ICD
  • patient's informed consent

排除标准

  • ventricular fibrillation will not be induced during the implantation or revision of ICD

结局指标

主要结局

The ability of AED to recognise induced VF

时间窗: 24 hours

The ability of AED to correctly recognise ventricular fibrillation from a bipolar ECG recorded within an area of mobile phone: is the recognition good enough to automatically divide the rhythm correctly into categories of shockable and non-shockable?

次要结局

  • Quality of VF(24 hour)

研究者

发起方
North Karelia Central Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sakari Syvaoja

MD

North Karelia Central Hospital

研究点 (2)

Loading locations...

相似试验