The ASPIRE Trial is a research study to determine if use of a mechanical chest compression device, the AutoPulse™ Resuscitation System (Revivant Corporation, Sunnyvale, CA) can improve the rate of survival from sudden cardiac arrest (SCA). SCA is a condition in which the heart unexpectedly stops pumping blood and so causing a person to collapse and become unconscious. If blood flow is not restored very quickly, the victim will die or have severe brain damage. SCA is very common in the United States, striking about 350,000 persons a year; less than 10% of these victims are saved by current treatment.
The ASPIRE Trial will provide the participating EMS agencies with the AutoPulse device for alternating one month periods. One month EMS will perform standard CPR with manual chest compressions (pushing on a victim's chest with their hands) and the next month they will use the study device. All other treatment will remain the same. The study is expected to last about 1-2 years.
Preliminary studies have shown the AutoPulse device, which has been approved for patient use by the United States Food and Drug Administration (FDA), to generate better blood flow than manual CPR. It is also hoped that the device will allow more continuous chest compressions. The purpose of the ASPIRE Trial is to see if these advantages lead to improved survival for persons who suffer sudden cardiac arrest outside the hospital
This study has been approved by the University of Pittsburgh Institutional Review Board and the Pennsylvania Department of Health.
The investigators will follow every patient who has a sudden cardiac arrest within the study communities during the time of the study to determine if they are still alive four hours after the first emergency call for help is received at the 911 center. Patients who are alive after four hours will continue to be followed for up to three months. At three months, surviving study subjects will be asked a few questions on the telephone to determine how well they are able to perform activities in their daily lives.
We anticipate that about 500 cardiac arrest patients will be enrolled locally and about 2330 across all five study sites in order to have enough patients to determine if there is an impact of the AutoPulse on survival.
We have developed a set of frequently asked questions that you can read if you would like more information. It is available here.