STUDY OVERVIEW

Every year, 325,000 Americans die because their hearts suddenly stop beating. This is called sudden cardiac arrest or just cardiac arrest. Cardiac arrest is a major health problem, killing more Americans than lung cancer, breast cancer and HIV/AIDS combined.

For forty years, giving chest compressions and ventilations with a technique called CPR¹ has been the standard of care for victims of cardiac arrest. While CPR can help to get blood recirculating to the heart and brain², research shows that it is difficult to do well, even by trained professionals. Despite CPR and the increasing presence of defibrillators that can get an erratic heart beating normally again, typically only 5 to 15 percent of cardiac arrest victims will survive, with survival rates as low as 1% in some larger cities. Something more needs to be done.

Assisted CPR - chest compressions done by a machine in combination with manual chest compressions performed by trained rescuers - could dramatically improve survival rates by providing better, more consistent compressions than manual compressions alone. This is precisely what the CIRC AutoPulse Trial³ is designed to find out.

The CIRC Trial will test the effectiveness of the FDA-cleared AutoPulse® automated chest compression device by comparing its performance in combination with manual compressions to manual chest compressions alone. Medical oversight will be provided by world-renowned CPR expert Dr. Lars Wik of Norway. The FDA-cleared AutoPulse has been commercially available for over four years and is in use worldwide. It is manufactured by ZOLL Medical Corporation, which is the trial's sponsor.

There are a number of international locations selected for this important trial. Each has gone through extensive training around the very strict protocol established for the trial, including proper use of the AutoPulse, in order to be cleared and certified for participation.

The trial is being conducted according to very strict guidelines⁴, and has been reviewed by local institutions that are set up to protect patients' rights and their health⁵.

Patient safety and privacy are of utmost importance. An independent board⁶, made up of several physicians and one statistician, is responsible for monitoring the safety of the trial. Should the board have any concerns about the safety of the trial, it can immediately stop it. The process of selecting patients for one treatment or another in the trial is completely randomized and non-biased. All patient data are anonymous and protected, with patients being identified only by a number.

Because patients are unconscious when suffering from sudden cardiac arrest, they can't be asked whether they would be willing to participate in the trial. When someone is a victim of cardiac arrest, fast action is required, with survival rates decreasing 7-10% for every minute of delay. Because every second of delay is critical to a patient's survival, relatives can't be asked for their approval either while the cardiac arrest victim is being treated by medical personnel. The patients or the relatives cannot give what is called informed consent at the time of treatment. However, the patient or the relatives can at any time ask that the patient's information be removed from the trial data. Please keep in mind that CIRC is not using experimental treatments; both manual CPR and the AutoPulse are commonly used globally. Regardless of what treatment the patient receives, it will be an accepted form of treatment.

The hope is that this trial is going to help advance the field of resuscitation, with the potential to identify a treatment protocol that will improve survival rates from sudden cardiac arrest.
¹ Cardiopulmonary Resuscitation
² If done according to American Heart Association Guidelines
³ Circulation Improving Resuscitation Care
⁴ Good Clinical Practices, Declaration of Helsinki, and other national and international guidelines
⁵ US: Institutional Review Boards associated with the local hospitals. Each IRB has read and approved the protocol suggested for CIRC.
⁶ Data and Safety Monitoring Board, DSMB