University of Pittsburgh's Department of Emergency Medicine to Test Effectiveness of Mechanical Chest Compression Device
Notice of public disclosure for emergency medicine research
PITTSBURGH, June 9, 2004 As part of an international study, researchers in the department of emergency medicine at the University of Pittsburgh School of Medicine will test the effectiveness of a mechanical chest compression device to see if it does a better job than manual chest compressions for the treatment of out-of-hospital sudden cardiac arrest.
The University of Pittsburgh is one of five centers participating in the AutoPulse Assisted Prehospital International Resuscitation (ASPIRE) Trial to evaluate the safety and effectiveness of AutoPulse, developed by Revivant Corporation of Sunnyvale, Calif.
The AutoPulse Resuscitation System is a U.S. Food and Drug Administration approved external device that is portable and designed to provide consistent automated chest compressions during cardiopulmonary resuscitation (CPR). The device resembles a small surfboard, and patients in cardiac arrest are placed on it and strapped to the board at the chest. The operator then pushes a button to begin the compressions. The AutoPulse is designed to generate chest compression cycles that produce a palpable pulse. During earlier human studies, the AutoPulse generated blood flow to the heart, which was nearly 125 percent of that generated by conventional CPR. Because of the optimal circulatory pressure, AutoPulse also has the potential to improve the circulation of drugs.
Sudden cardiac arrest is the sudden loss of heart function. The mortality rate is more than 90 percent and death usually occurs within minutes unless CPR and rapid defibrillation is available. Despite many advances in medical care, there has not been a significant improvement in the survival rate of cardiac arrest in 30 years.
With poor survival statistics like this, it is important to find alternative methods to combat sudden cardiac arrest, which claims more than 350,000 lives each year, said Vincent N. Mosesso, Jr., M.D., associate professor of emergency medicine at the University of Pittsburgh, medical director of the University of Pittsburgh National Center for Early Defibrillation and principal investigator of the Pittsburgh study.
Observations in the prehospital setting have found that maintaining manual chest compressions is one of the more difficult tasks for a variety of reasons. Additionally, observations in the laboratory with trained paramedics show that the depth of compressions and compression rate diminish rapidly with time from the onset of CPR without the participant being aware of his/her decreased effort.
Because this study could affect anyone living in areas served by the participating EMS agencies, both the university and the researchers are seeking comments from the public. To explain the research and answer questions, the Pitt researchers will hold public forums in the participating communities.
According to federal law and university policy, those who participate in a clinical research study must provide informed consent. Because of the nature of this trial, it is impossible to obtain consent at the time of cardiac arrest. For this reason, the researchers are notifying the public that informed consent will be waived. Researchers will make every attempt to be in contact with family members and, if possible, the cardiac arrest patient to provide notification and obtain consent for continued participation as soon as possible after subject enrollment.
The Pitt researchers will work with seven local emergency service (EMS) agencies to train paramedics on how to use the AutoPulse. During the one-year study, half of the patients will receive manual chest compressions and the other half will receive compressions with the AutoPulse. Patients who survive and agree to continue to participate in the study will be followed for three months after the event. At the conclusion of the study, the researchers will compare the two methods to see which group of patients had a better outcome.
Other cities participating in the ASPIRE Trial include Seattle (the coordinating center with Al Hallstrom, Ph.D., as principal investigator and professor of biostatistics at the University of Washington); Calgary, Alberta; Vancouver, British Columbia and Columbus, Ohio. With all of the centers combined, the researchers hope to enroll 2,300 patients. The Pittsburgh researchers hope to enroll 500 patients locally.
The seven EMS agencies participating in the ASPIRE Trial include Baldwin EMS, Tri-Community South EMS, Medical Rescue Team South, Northwest EMS, McKeesport Area EMS, Eastern Area Prehospital Services and Ross/West View EMS.
The department of emergency medicine at the University of Pittsburgh School of Medicine, under the direction of Paul M. Paris, M.D., F.A.C.E.P., is one of the largest academic departments in the United States. Roughly 40,000 patients are treated each year. Department faculty are recognized authorities in many specialty areas of emergency medicine, including prehospital care, pain management, decision guidelines, airway management, toxicology, resuscitation medicine, disaster planning and injury prevention.
The ASPIRE Trial is funded through a grant from Revivant Corporation.
For more information about the public forums, or to make comments or ask questions about the ASPIRE Trial, researchers can be contacted at the following:
Call the ASPIRE principal investigator at 412-647-2694.
University of Pittsburgh
Department of Emergency Medicine
230 McKee Place, Suite 911
Pittsburgh, Pa., 15213
Attention: Vincent N. Mosesso, M.D., principal investigator