Ventricular Fibrillation Clinical Trial
Official title:
Automatic External Defibrillation Monitoring in Cardiac Arrest
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.
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.
Group 2: This group includes patients admitted to telemetry unit who will have an AECD
attached to the chest wall and who will also undergo standard measures of CPR in case of
cardiac arrest.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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