Risk/Benefit Public Announcement

Public Notification of an Exception to

the Requirements for Informed Consent under Emergency Circumstances for a CPR

Research Study in Milwaukee County, WI

This announcement serves as public notification of a cardiopulmonary resuscitation (CPR) research study that will begin February 2008 and will be performed in Milwaukee County, Wisconsin using the Food and Drug Administration's (FDA) set of regulations allowing exception to informed consent in emergency research circumstances. The study will include all adult victims of cardiac arrest in whom paramedics from the Milwaukee County Emergency Medical Services (EMS) System attempt resuscitation. All patients will receive standard resuscitation care. The only difference for this study will be that half of the patients will be randomized (a 50 - 50 chance, similar to "flipping a coin") to receive 30 seconds of CPR prior to the paramedics analyzing their heart rhythm and use either an active or sham (has no effect, acts like a hollow conduit) Impedance Threshold Device (ITD). The other half will receive 3 minutes of CPR prior to the paramedics analyzing their heart rhythm and use either an active or sham ITD.

Cardiac arrest is the sudden loss of pulse and breathing. CPR is typically performed until normal heart function can be restored. The purpose of the study is to compare the effectiveness of 30 seconds or 3 minutes of standard CPR prior to paramedics analyzing their heart rhythm with an active or sham ITD. Preliminary studies indicate that blood flow to the heart, brain and other vital organs is improved with the use of an ITD. The experimental aspect of this study is that it is unknown whether the improved blood flow effects and 30 seconds or 3 minutes of CPR prior to rhythm analysis are beneficial to the patient's survivability to hospital discharge neurologically intact.

All research contains risks. The risks of this study include increased work of breathing, fluid buildup in the lungs, failure of the device, chest fractures, chest or abdominal organ damage, or skin bruising. However previous studies have not observed device-related adverse events. Surviving cardiac arrest with damage to the brain is a potential risk for any patient undergoing any method of CPR. It is possible that survivors in one group may have more damage to the brain. This will be monitored on an ongoing basis and the study stopped if it occurs. There may also be some unknown or unanticipated risks because the ITD used is relatively new and its use in this study is an attempt to advance medical knowledge. Every precaution will be taken to assure personal safety.

The information that is obtained from this study may be useful scientifically and possibly helpful to others. The benefit that may reasonably be expected from participating in this study is improved effectiveness of CPR or an increased chance for survival, but these potential benefits are not guaranteed. There are no financial risks or benefits for study participation. For this study, there are no appropriate alternative procedures that are known to be advantageous during cardiac arrest. All information obtained from this study that can be identified to an individual person will remain absolutely confidential. The scientific or medical information not identifiable with a patient resulting from the study will be presented at meetings and published so that the information can be useful to others.

The FDA has implemented regulations allowing an exception to informed consent under emergency research circumstances where acquiring written informed consent is impossible and there is reasonable scientific evidence to suggest a possible benefit from a new intervention. FDA regulations require public notification to inform the community that a research project will be done that may impact members of the local population. This notification must be made prior to the initiation of the study, which will begin on [DATE], and continue through [DATE] (anticipated). Public notification will also occur after the study is completed.

This study meets the FDA guidelines for exception to informed consent under emergency circumstances because informed consent cannot be obtained from a victim of sudden cardiac arrest. Interested parties with questions or concerns are encouraged to contact the principal investigator, Dr. Tom P. Aufderheide, either by phone (414-805-6493), mail (Department of Emergency Medicine, 9200 W. Wisconsin Ave., Froedtert Hospital East, PV1, Milwaukee, Wisconsin 53226 or email (taufderh@mcw.edu), or visit the WEB site at (www.mcw.edu/rocprimed). Feedback from the community may be used to further modify the design of the study.