AutoPulse Assisted Prehospital International Resuscitation (ASPIRE) Trial

This document is intended to provide an informational summary of the above trial to residents of the communities wherein the study is being conducted.

Out of hospital cardiac arrest is a common and highly lethal condition in this country and much of the world.  In fact, heart disease is the leading cause of death in the United States, and most of those deaths are due to sudden cardiac arrest.  Many others succumb to cardiac arrest secondary to other causes.  While about one third of cardiac arrest victims can be treated with rapid defibrillation, the majority require basic cardiopulmonary resuscitation (CPR). CPR is a combination of mouth-to-mouth ventilations and chest compressions that results in artificial circulation of blood. For many victims of sudden cardiac arrest it is the only hope of survival. Recent studies have shown the importance of high quality, uninterrupted chest compressions to improve blood flow to the heart and brain.

Continuous high quality CPR is difficult to provide even for trained professionals. Manual chest compressions require strength and stamina.  When emergency workers perform procedures, or when they move the patient into the ambulance, chest compressions must stop momentarily. When compressions are stopped, even for a short time, the blood flow to the heart also stops.

To address this problem, an international research study is being conducted to test a new, FDA approved device that can mechanically compress the chest. The University of Pittsburgh is one of five centers in the United States and Canada participating in the study. The battery-powered device, the AutoPulse™ Resuscitation System (Revivant Corporation, Sunnyvale CA), performs chest compressions with a pneumatic strap that is placed around the victim’s chest.  The device delivers continuous compressions at a uniform depth and force.  Initial studies have demonstrated improved blood flow to the brain and heart as compared with manual chest compressions. This study seeks to determine whether use of the AutoPulse improves survival from sudden cardiac arrest that occurs outside of the hospital.

The ASPIRE Trial is led nationally by the University of Washington, Seattle, WA.  Approximately 1300 patients are expected to be enrolled nationally, with about 350 in Pittsburgh. The Pittsburgh site is coordinated by researchers at the University of Pittsburgh, whose Institutional Review Board (IRB) has reviewed and approved the study protocol.  Locally the study will be conducted with seven Emergency Medical Service (EMS) agencies that serve 38 municipalities.  The participating EMS agencies are: Baldwin EMS, Eastern Area Pre-hospital Services, McKeesport Ambulance and Rescue Service, Medical Rescue Team South EMS Authority, Northwest EMS, Ross/West View EMS Authority, and Tri-Community South EMS.  EMS agencies will be randomly assigned to either use the AutoPulse device or do manual compressions in one month blocks over the course of the study, expected to last about one year.  Investigators will determine whether use of the device improves the rate of survival to hospital admission and the rate of survival to hospital discharge.

Because patients in cardiac arrest are unconscious and cannot give consent to participate in this research, researchers must take extra steps to ensure that the rights of study patients are properly protected.  Patients or their next of kin will be notified of enrollment in the study as soon as feasible.  Standard informed consent will be obtained for continued participation and follow up.  The IRB ensures that the notification and consent procedures properly protect the rights of all patients.  A national Data and Safety Monitoring Board will also oversee the study.

This summary is an effort to inform residents of the communities where the study is being conducted, which is one of the special requirements for such studies.  As with any study, there are potential risks. The only known additional risks compared to standard CPR is that of skin abrasions from the AutoPulse chest strap and mechanical failure leading to interruption of or less effective chest compressions.  Patients who survive and agree to participate in a follow up survey may experience some emotional distress from answering questions related to their health.  The above committees will monitor the trial for any increased risk or side effects that may occur from this study.