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临床试验/NCT00382928
NCT00382928已完成1 期

Automatic External Defibrillation Monitoring in Cardiac Arrest

Foundation for Atlanta Veterans Education and Research, Inc.2 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2006年10月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
192
试验地点
2
主要终点
Number of Participants Without Defibrillation

研究概览

简要总结

We propose to randomize automatic external cardioverter/defibrillators (AECD) in patients who are at high risk for life-threatening abnormal heart rhythms (arrhythmias) and are admitted to the telemetry ward, all other treatments being constant including cardiopulmonary resuscitation.

We hypothesize that the automatic, rapid, accurate and specific diagnostic and therapeutic technology used in AECDs will further increase the rate of survival in patients with cardiac arrest through rapid and automatic defibrillation, independent of operator initiation, as compared to standard cardiopulmonary resuscitation initiated by healthcare providers.

详细描述

Cardiac arrest (CA) is defined as the sudden cessation of effective cardiac pumping function as a result of either ventricular asystole (inactivity of the heart) or pulseless ventricular tachycardia/ventricular fibrillation (VT/VF). Pulseless ventricular tachycardia/ventricular fibrillation is an abnormal electrical activity of the ventricles of the heart. Rapid diagnosis and treatment are essential because first, more than a few minutes of total CA results in permanent damage to the brain due to lack of oxygen, and second, the success of resuscitative measures is related to the rapidity with which they are instituted following arrest. For a person in VT/VF the probability of successful defibrillation and subsequent survival to hospital discharge is directly and negatively related to the interval between onset of VT/VF and delivery of first shock.

Comparison: By using AECDs we will evaluate if an automatic, rapid, accurate and specific diagnostic technology will further increase the rate of survival in patients with VT/VF by rapid and automatic defibrillation, independent of operator initiation, as compared to standard cardiopulmonary resuscitation (CPR) with conventional defibrillators initiated by healthcare providers. This trial will be a randomized, controlled trial and will test if AECDs can improve outcome measures when compared to traditional responses.

Conventional defibrillators are manually operated defibrillators that have to be attached to the patient and operated by a healthcare provider or layperson. In contrast, the purpose of AECDs is to automatically detect life-threatening arrhythmias and deliver external shocks according to a programmable prescription for hospitalized patients, who may be at transient risk for the development of life-threatening arrhythmias. AECDs immediately and automatically monitor, detect and treat cardiac arrhythmias with no human intervention. The AECD proposed to be utilized in this trial, PowerHeart CRM, a product of Cardiac Science, Inc, has been evaluated in the hospital setting to assess safety and efficacy, and has been approved by the FDA to be prophylactically attached to hospital patients and provide automatic defibrillation therapy without human intervention.

All patients admitted to the telemetry unit will be asked to volunteer for this study. Up to 3,000 patients will be asked to volunteer in this study during their stay in the telemetry unit. This study will evaluate if there is a way to improve survival in CA by comparing two groups

Group 1: This group includes patients admitted to telemetry unit who will undergo standard measures of CPR in case cardiac arrest is suspected.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

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

  • All patients admitted to telemetry ward and emergency department
  • Age > 18 years.

排除标准

  • Pregnant women
  • Patients with R wave less than 0.5 millivolts.
  • Patients with functioning Internal Cardiac Device.
  • Patients with cardiac pacemakers if oversensing by AECD is demonstrated (double counting of pacer spikes).
  • Patients with visible chest lesions that would prevent AECD pad placement.
  • Patients who are designated Do Not Resuscitate.
  • Right bundle branch block.
  • Patients with Parkinson's disease.
  • Patients with seizure disorders

结局指标

主要结局

Number of Participants Without Defibrillation

时间窗: 10 minutes

Time to defibrillation: interval between onset of VT/VF and delivery of first shock. Expected time to defibrillation for AECD group: 30±30 seconds; expected time to defibrillation for Standard of Care group: 180±180.

次要结局

  • Survival to Discharge(At discharge)
  • Cerebral Performance at Discharge(At discharge)
  • Frequency of Abnormal Rhythms Monitored by the AECD(During the duration of hospital admission on the telemetry ward.)

研究者

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

A. Maziar Zafari

Chief, Cardiology

Atlanta VA Medical Center

研究点 (2)

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