How many people experience cardiac arrest?

Each year about 500,000 people in the United States experience cardiac arrest. In a word, the heart suddenly stops. The heart may stop for a number of reasons, including heart attack, drowning or chocking. About 350,000 of those cardiac arrests occur outside of a hospital. Each year, in the City of Oshkosh, about 100 people have a cardiac arrest.

What's the immediate treatment for a cardiac arrest?

CPR is the first line of treatment. However, cardiac pulmonary resuscitation is not very effective. The vast majority of patients in cardiac arrest never survive, despite the expertise and highly developed skills of paramedics and physicians. In Milwaukee County, the survival rate is 9%, which is 4% above the national average.

Why isn't CPR as effective as it might be?

There are many reasons why the survival rate from cardiac arrest is dismal. One reason is the amount of time that elapses between the cardiac arrest and the start of CPR. Another reason is the mechanical inefficiencies of the resuscitation equipment used by paramedics. Sometimes the brain or neurologic function is adversely affected by the lack of oxygen before CPR begins. 

How does CPR work?

An emergency technique, CPR is used to revive a person whose heart or breathing has stopped. When the heart and lungs stop, nourishing oxygenated blood is not pumped through the body. Using mouth-to-mouth resuscitation or an airbag, along with cardiac massage (chest compression), the rescuer may be able to revive the victim. CPR is most effective when it's performed within the first four minutes after cardiac arrest.

How can the survival rate be improved?

In an effort to improve the current poor outcome of patients after cardiac arrest, a new respiratory valve has been developed to enhance the efficacy of CPR equipment.

What are the new devices and how do they work?

They are called the ResQPOD® and ResQPump®.

The ResQPOD® is a one-way value that fits between the airbag  -- used to introduce air into the cardiac arrest victim -- and the endotracheal tube  placed into the patient's throat and lungs. The Pod can also be used with a facemask that fits over the patient's nose and mouth and other resuscitation devices. During CPR the one-way valve creates a small vacuum within the victim's chest, increasing the return flow of blood to the heart.

The ResQPump® has a plunger device which is placed on the chest. When used during CPR it allows a greater vacuum to form during decompression by pulling up the rib cage.

Will these devices save lives?

Preliminary ResQPOD® studies have demonstrated:

• A return flow of blood to the heart by 75%.
• Increased blood flow to the brain.
• An increased survival rate.
• Survivors reported quality of life to be the same as prior to their cardiac arrest. 

However, none of these benefits are guaranteed.

Why are we doing another study?

The Pod has been successfully used on humans in Milwaukee County and in Europe. But more study is needed. This study of cardiac arrest victims will be conducted by Medical College of Wisconsin physicians and Oshkosh Fire Department paramedics, and in 4 other locations around the nation.

How will the Medical College of Wisconsin study be conducted?

The purpose of the study is to compare the outcome in victims of cardiac arrested who are treated with standard CPR techniques, those who are treated with standard CPR along with the new Pod, and Those treated with the new ResQPOD® and ResQPump®. Exactly 1033 patients will be studied in each group over the course of about 3 years.

The US Food and Drug Administration, the National Institutes of Health and the Institutional Research Boards of the Medical College of Wisconsin, Theda Clark Hospital, Mercy Hospital and Aurora Oshkosh Medical Center have approved this study.

Which cardiac arrest victims will be treated with the Pod and Pump?

This will be a randomized study. There is a 33% chance that a cardiac arrest victim will receive standard CPR without the Pod, standard CPR with the Pod, and CPR with both the ResQPump™ and ResQPOD® devices. Randomization is necessary to assure that research findings do not occur from bias or chance.

Who will be included in the study?

• The cardiac arrest patients must be at presumed to be at least 18 years old.
• The patient must be treated by the Oshkosh Fire Department paramedics, within the Oshkosh city limits.
• Patients who received trauma, such as that from an automobile accident or gunshot, will be excluded from the study.
• Patients who have a pre-existing "do not resuscitate" order will be excluded.
• Patients who are known to be pregnant will be excluded.
• Patients who are prisoners will be excluded.

Are there potential risks in the study?

Performing CPR, with or without the new devices, can pose a risk. Surviving cardiac arrest with damage to the brain is a potential risk for any patient receiving CPR. The one-way Pod that fits between the airbag  -- used to introduce air into the cardiac arrest victim -- and the facemask placed over the patient's nose and mouth could fail and not provide any benefit to the victim.

The ResQPOD® could become contaminated with bodily fluids and force EMTs and paramedics to discontinue using it. There is the possibility the Pod could cause an excessive buildup of fluids in the lungs. The ResQPump® may cause bruising of the skin on the chest.

There may be unknown or unanticipated discomfort or risk from using the Podor Pump. Death from cardiac arrest is a potential risk for any patient receiving CPR.

Will a cardiac arrest victim's records be kept confidential?

Yes, information gathered in the process of this study will remain confidential by the Medical College of Wisconsin research team, the Milwaukee County paramedics, the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). The NIH is funding this study. 

How can you get more information about the study?

Please contact Tom P. Aufderheide, MD, professor of emergency medicine at the Medical College of Wisconsin.

Phone:  (414) 805-6493

E-mail: taufderh@mcw.edu
Fax: (414) 805-6532
Mailing address: Department of Emergency Medicine, Froedtert Hospital East, 9200 W. Wisconsin Ave., Milwaukee, WI 53226

For more information on Dr. Aufderheide, please follow this link: Brief Bio 

How are cardiac arrest victims and their families informed about this research?

Obtaining an "informed consent" from victims of cardiac arrest is always impossible. To allow researchers to possibly improve the survival rate of individuals suffering from cardiac arrest, the US Food and Drug Administration (FDA) has issued guidelines for the waiver of consent under emergency circumstances, as long as the research has the prospect of direct benefit to the patient. However, consent information is provided to the patient, legal representative and the family as soon as possible. 

In an attempt to inform as many people as possible before the research begins, the researchers are required to disclose to the public the nature, risks and benefits of the study. This is being done through a variety of means:

• This website.
   
• Publicly announced meetings.
   
• Newspaper advertising.
   
• News stories.
   
• Consultation with survivors of cardiac arrest.
   
• Consultation with family members of survivors and non-survivors of cardiac arrest.
   
• Consultation with the administrative staff of the Milwaukee County Paramedics.
   
• Consultation with community leaders.
   
• Consultation with representatives of numerous other community organizations, such as the American Red Cross, the Visiting Nurse Association, Milwaukee Health Department, Wisconsin American Heart Association, Milwaukee area hospitals, churches and ethnic health organizations.

Why has the FDA changed its rules on informed consent?

The FDA has issued these regulations to allow research, designed to improve medical treatment, to occur under emergency circumstances in which obtaining informed consent is not feasible while doing everything possible to protect the rights and safety of human subjects.

Does the cardiac arrest study meet the FDA requirements for waiver of informed consent?

Yes, the Medical College of Wisconsin research study meets these requirements:

• A life-threatening situation with unproven or unsatisfactory treatment where research is necessary to improve outcome. Cardiac arrest is an immediately life-threatening condition with unsatisfactory treatment.
  
   
• Obtaining informed consent is not feasible because the patient is unresponsive and treatment must begin immediately if there is any hope for survival.
  
   
• Participation in research has the prospect of direct benefit because the situation necessitates an intervention, science supports the potential of direct benefit and the risks of the research are reasonable compared to the medical condition.
  
   
• The research could not practicably be done without waiver of informed consent.
  
   
• The potential therapeutic window is short (in the case of cardiac arrest just a few minutes).
  
   
• The Medical College of Wisconsin Research Board approves the consent document and procedures for the subject or legal representative.

Will the victim's family know that research was part of the CPR?

Information will be provided to the patient, legal representative and the family as soon as possible. Documentation will be kept on file according regulations.

Additional protections provided by FDA regulations include public disclosure prior to starting the study, public disclosure after completion of the study, and an attempt to contact family members whenever possible.