MCW One of 10 Centers to Assess New Cardiac Arrest Device

Approximately half a million cardiac arrests occur in the United States each year. Nearly two thirds - about 350,000 cardiac arrests - occur outside the hospital.

Starting in February, a cardiopulmonary resuscitation (CPR) research study will begin in Milwaukee County, Wisconsin, including all adult victims of cardiac arrest in whom paramedics from the Milwaukee County Emergency Medical Services (EMS) System attempt resuscitation. About 800 cardiac arrests occur each year in Milwaukee County.

The goal of the study is to compare the effectiveness of standard CPR with and without a new biomedical device called an Impedance Threshold Device (ITD). Preliminary studies indicate that blood flow to the heart, brain and other vital organs is improved with the use of an ITD.

Cardiac arrest is the sudden loss of pulse and breathing. CPR is typically performed until normal heart function can be restored. The study will 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 (which has no effect).

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.

Researchers at the Medical College of Wisconsin will compare survival rates and quality of life issues for the patients.

"This is very important research, which has the potential to save lives and improve delivery of health care nationally," said Tom Aufderheide, MD, Medical College of Wisconsin Professor of Emergency Medicine and an emergency medicine physician at the Froedtert & Medical College Emergency Department & Trauma Center.

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.

Community consultation was done via a randomized phone survey of more than 500 Milwaukee County residents age 18 and over. When explained the design of the study, they overwhelmingly expressed support to proceed with the study. The Food and Drug Administration requires this community consultation because informed consent cannot be obtained from a patient suffering a cardiac arrest.

The Medical College of Wisconsin is one of 10 centers in the country participating in the study as part of the Resuscitation Outcomes Consortium (ROC), which was created to conduct clinical research in the areas of cardiopulmonary resuscitation and traumatic injury.

Interested parties with questions or concerns or information on obtaining opt-out bracelets are encouraged to contact the principal investigator, Dr. Tom P. Aufderheide, MD, at 414-805-6493, or by mail at the Department of Emergency Medicine, 9200 W. Wisconsin Ave., Froedtert Hospital East, PV1, Milwaukee, Wisconsin 53226, or visit the ROC website. Feedback from the community may be used to further modify the design of the study.

MCW Health News presents up-to-date information on patient care and medical research by the physicians of the Medical College of Wisconsin.