Cardiac Arrest Clinical Trial
Official title:
AutoPulse Assisted Prehospital International Resuscitation Trial (ASPIRE)
The AutoPulse Assisted Prehospital International Resuscitation (ASPIRE) Trial compares the efficacy of circulatory assist by manual chest compression versus an automated chest compression device (AutoPulseā¢) during the resuscitative attempt following out-of-hospital cardiac arrest.
Extensive early experience yielded no reliably validated instances of out-of-hospital arrest
associated with tachyarrhythmia being resuscitated without successful defibrillatory shock.
This together with the increasing availability of automated external defibrillators (AEDs),
at increasingly attractive prices, led, in the past decade, to a strong emphasis on early
defibrillation. This emphasis may have inadvertently resulted in a decreased emphasis on
cardiopulmonary resuscitative techniques, particularly in light of publications decrying the
uniformly poor quality of CPR performed by laymen, medical professionals, and even EMS
personnel. However, recent research strongly suggests that assisted reperfusion prior to
defibrillation may actually significantly improve survival rates. These reports, based on
clinical studies, have received substantial confirmation from carefully controlled
laboratory studies, particularly in pigs.
If assisted reperfusion prior to defibrillation (and subsequent to failed shock) is
important, it is reasonable to suppose that the benefit is related to quality of chest
compressions. Observations of resuscitative efforts in the field indicate that maintaining
compressions is one of the more difficult tasks, for a variety of reasons. Observations in
the laboratory with trained paramedics show that the depth of compression and the
compression rate diminish rapidly with time from the onset of CPR, without the participant
being aware that his/her effort is actually diminished.
The desire to provide consistent and quality compressions has led to the development of a
mechanical compression assist device called the AutoPulse. It is a self-contained, portable
chest compression device that is rapidly field deployable.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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