PAD Trial Pittsburgh Site

Study on Use of AEDs in Public Places to Get Underway in Pittsburgh

February 14, 2001

Can a non-medical person be effectively trained to use an automated external defibrillator (AED) in the event that someone should fall victim to a sudden cardiac arrest? Will the use of AEDs by trained volunteers save not only lives, but also thousands of dollars in hospital stays and cardiac rehabilitation services?

To help answer these questions, researchers in the department of emergency medicine at the University of Pittsburgh School of Medicine are participating in a large multi-center research known as the public access defibrillation (PAD) trial. To explain the trial and answer questions, the Pitt researchers are holding a public forum beginning at 7:15 p.m. on Wednesday, February 21 in Freehof Hall at the Rodef Shalom Temple, 4905 Fifth Avenue, at the corner of Fifth and Morewood in Oakland. Free parking is available in the Rodef Shalom lot. Enter the temple from the parking lot entrance.

The two and a half-year study is being conducted at 24 centers throughout the United States and Canada. The University of Pittsburgh has identified 40 public sites throughout western Pennsylvania that have agreed to take part in the study. Some of the places identified for the Pittsburgh study so far include The Gateway Clipper Fleet, Allegheny County Housing Authority, One Oxford Centre and Monroeville Mall. A complete listing of all 40 sites will be made available at the public forum.

Whether the sites will have AEDs or not will be determined by a randomization process. Those sites without AEDs will have non-medical volunteers trained in the current optimal community standard of care, which includes how to recognize cardiac arrest, how to access the 9-1-1 system and how to perform cardiopulmonary resuscitation (CPR). Sites where the AEDs are placed will have the non-medical volunteers trained to use AEDs in addition to delivering the current optimum community standard of care.

Information gathered from the study will enable researchers to examine multiple facets on the use of AEDs - where and how they should be deployed, how many should be deployed, whether the public can use them effectively and the overall cost to the public.

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 obtain consent at a later time.

"If results of this study show a significant increase in survival from sudden cardiac arrest, this would be one of the most important medical breakthroughs of the last 20 years," says Vince Mosesso, M.D., assistant professor of emergency medicine at the University of Pittsburgh School of Medicine and principal investigator of the study.

An AED is a small portable device that analyzes heart rhythms and advises the operator, through computerized voice instructions, when to push a button to deliver a potentially lifesaving shock to the victim. They are safe, effective and easy to use. Most AEDs today are no bigger than a laptop computer and weigh less than 10 pounds.

Bystander CPR has helped somewhat in reducing deaths associated with sudden cardiac arrest. However, even with CPR, only about 5 percent of people who suffer cardiac arrest survive, and more than 700 people die each day in the United States.

Recent studies conducted by Dr. Mosesso at the University of Pittsburgh proved valuable time can be saved when emergency first responders, such as police, use AEDs within the first minutes from collapse. The PAD trial is a continuation of the former study, taking it one step further by training non-medical people how to use AEDs.

At least 800 volunteers are being recruited and trained for the Pittsburgh trial. Researchers note that there is often a concern of legal liability associated with providing assistance in an emergency medical situation. However, Pennsylvania has "Good Samaritan" laws to protect those who assist in an emergency medical situation.

Some of the potential risks for victims of cardiac arrest enrolled in the study include the rare possibility of an electric shock of a heart rhythm that is providing circulation to the victim, and the uncommon likelihood of a subject with an unknown Do Not Resuscitate (DNR) order. PAD trial coordinators will ensure that steps will be taken to reduce those risks by making certain that 9-1-1 systems are in place at all sites, volunteers are thoroughly trained on AED use as well as CPR, and volunteers are trained on how to recognize victims with DNR orders per Pennsylvania law.

For more information about the public forum, or to make comments or ask questions about the PAD trial, researchers can be contacted at the following:

By Telephone:
Call the PAD study coordinator at (412) 647-7942. For people outside the 412 area code call toll-free at 1-866-AED-INFO
(1-866-233-4636)

By Mail:
University of Pittsburgh
Department of Emergency Medicine
230 McKee Place Suite 911
Pittsburgh, Pa., 15213
Attention: Venard Campbell, study coordinator
By E-mail: campbellvj@msx.upmc.edu
By Web: http://www.early-defib.org.
Follow link to PAD trial

Funding for the PAD trial is supported by the National Heart, Lung and Blood Institute, the American Heart Association and manufacturers of AEDs. Thomas Stein, M.D., F.A.C.E.P., at Allegheny General Hospital is co-investigator of the PAD trial's Pittsburgh site.