Frequently Asked Questions What is this new technique and how does it work? Researchers are testing two new investigational devices - the ResQPump and ResQPOD. The ResQPump assists EMS providers in performing active compression/decompression during CPR. Not only does the device compress the chest and therefore the heart during CPR, but it also actively decompresses the chest, which increases the amount of blood that is circulated during CPR. The ResQPOD is a one-way valve located between the airbag (used to transport air into the lungs of the patient in cardiac arrest) and the endotracheal tube placed into the patient's throat and lungs. The valve can also be used with a facemask placed over the patient's nose and mouth or other resuscitation devices. During CPR, the one-way valve helps to create a small vacuum within the patient's chest, increasing the return flow of blood to the heart. Research has shown that the volume of blood circulated through the body during CPR can be doubled when using both of these devices. Preliminary studies using these two devices during CPR have shown that there is: Increased blood flow to the brain Increased survival rate However, none of these benefits are guaranteed. Why are we doing this study? The ResQPOD and ResQPump have been successfully used on humans in Europe and showed an increase in the amount of blood circulated during CPR, but more research is needed. This will be the first study in the United States investigating the use together of the chest compression/decompression and breathing valve devices. What is the purpose of the study? The purpose of the study is to compare the outcomes of people who experience out-of-hospital cardiac arrest and are treated with standard CPR techniques to those treated with one or both of the investigational new devices. How will the study be conducted? Over the course of about three years, 3,100 patients will be enrolled in this study. The study will include three treatment groups: 1. standard CPR; 2. standard CPR plus the ResQPOD; 3. active compression/decompression CPR using the ResQPump plus the ResQ POD. The U.S. Food and Drug Administration (FDA) and the Institutional Review Board (IRB) at St. Joseph Mercy Hospital (in addition to the Institutional Review Boards at other area hospitals involved in the study) have approved this study in Washtenaw and Livingston counties. Approval has also been granted by the Washtenaw/Livingston Medical Control Authority, who oversee the EMS providers. 1
Which cardiac arrest victims will be treated with the new devices? Each week, specially trained emergency response personnel will implement one of the three arms of the study. Randomization is necessary to assure that research findings are related to the research itself, and do not occur from bias or chance. Who will be included in the study? Out-of-hospital patients in cardiac arrest and who are 18 years of age or older Patients in Washtenaw and Livingston counties whose cardiac arrest is responded to by specially trained EMS personnel from Huron Valley Ambulance, Livingston County Ambulance, Stockbridge Ambulance, and fire departments in Ann Arbor, Ann Arbor Township, Augusta Township, Brighton, Chelsea, Dexter, Fenton, Fenton Township, Fowlerville, Green Oak Township, Hamburg Township, the Hartland/Deerfield/Tyrone Fire Authority, Howell, Lyon Township, Manchester, Milan, Northfield Township, Pittsfield Township, Putnam Township, Salem Township, Saline, Scio Township, South Lyon, Superior Township, Ypsilanti, Ypsilanti Township and Unadilla. What happens at the time of cardiac arrest? Family members, friends or co-workers at the scene of a cardiac arrest have the right to refuse use of the investigational devices on the cardiac arrest victim, if the victim has previously indicated their wishes not to be involved in this research. In order to refuse, a family member, friend or co-worker merely has to tell EMS providers and firefighters on the scene. In those instances, EMS providers will respect the wishes of the cardiac arrest patient, communicated by the family, friend or co-worker and will not use either of the two devices. Standard CPR will be performed instead of the active compression/ decompression CPR and all advanced cardiac life support techniques will be used. Who will not be included in the study? Patients who experience trauma, such as an automobile accident or gunshot. Patients who have a pre-existing "do not resuscitate" order. Patients with a recent history (within six months) of chest surgery. Patients with a family member who wishes to refuse participation in the study Are there potential risks involved in the study? Performing CPR, with or without the investigational new devices, can pose a risk. Surviving cardiac arrest with damage to the brain is a potential risk for any patient receiving CPR. Death from cardiac arrest is a potential risk for any patient receiving CPR. The one-way valve 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 valve could become contaminated with bodily fluids and force EMS personnel to discontinue using it. There is the possibility the valve could cause an excessive buildup of fluids in the lungs. In studies on humans in cardiac arrest, the rate of chest trauma (fractures and organ damage) from active compression/decompression CPR is similar to that of standard CPR, with the exception of superficial redness or bruising of the chest, which may occur in about half of all 2
patients. Rib fractures, if they occur, sometimes make it more difficult for the chest to expand and use of the ResQPump may help facilitate that. There may be other unknown or unanticipated discomfort or risks from using the valve. How are victims in cardiac arrest and their families informed about this research? In normal circumstances a patient is informed about a study before the person begins participation. Informing a person about a study is called informed consent. Informed consent is typically performed in an environment that allows for an informative dialog to occur about the study between the study doctor or nurse and the participant. One way to explain the study is for the study doctor to use a document called an informed consent. This document explains the study methods, procedures, risks and other important information. A participant that wants to be in a research study will typcially sign the informed consent document before any study procedures are perfomred. Obtaining a traditional prospective"informed consent" from patients suffering a cardiac arrest is impossible. To allow researchers to possibly improve survival rates of individuals suffering from cardiac arrest, the FDA has issued regulations that modify the process of obtaining informed consent for planned emergency research. This modified consent process, called a waiver of consent, is applicable as long as the research offers the potential of directly benefiting the patient. Every effort is made to provide the patient, family, or legal representative with information about the research, 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 Community 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 community leaders Consultation with representatives of numerous other community organizations, such as the American Red Cross, area hospitals and churches When a patient in cardiac arrest is brought to the hospital a representative from the research team will contact the patient, family, or legal representative in order to inform them about the research and obtain informed consent. You may choose not to participate and, if so, your data will not be used. You may withdraw from the study at any time, without penalty or loss of medical benefits. Any further participation in the research study is voluntary. Data will be collected from the medical record, and a patient that survives to hospital discharge will be interviewed either in person or by phone at 30 days, 90 days, and one year after discharge from the hospital. At those predetermined dates a physician and/or nurse will ask questions regarding the patient's neurological function. Why does the FDA have modified rules on obtaining informed consent for planned emergency research? The FDA has issued these regulations to allow planned emergency research, designed to improve medical treatment, to occur under emergency circumstances in which obtaining 3
informed consent is not feasible while doing everything possible to protect the rights and safety of human subjects. Does this cardiac arrest study meet the FDA requirements for waiver of informed consent? Yes, this planned emergency research study on out-of-hospital sufferers in cardiac arrest meets these requirements: A life-threatening situation with unproven or unsatisfactory treatment where research is necessary to demonstrate improved outcome 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, this is just a few minutes) The Institutional Review Board approves the informed consent document and procedures that assure the patient or family, or the patient's legal representative are informed of the study as soon as is feasible Will the family of the patient experiency cardia arrest know that research was part of the CPR? Information will be provided to the patient, family, or legal representative as soon as possible. Documentation will be kept on file by the researchers, according to FDA Regulations. Additional protections provided by the 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. Will the patients' records be kept confidential? Yes, information gathered during the course of this study will remain confidential, and may only be accessed by the research team, the EMS providers, the National Institutes of Health (NIH), the FDA and Advanced Circulatory Systems, Inc (company that makes the ResQPump and the ResQ POD). The NIH is funding this study. Additionally, local Institutional Review Boards (IRB) from other participating hospitals will have access to patient records at their hospitals. These IRBs include St. Joseph Mercy Health System, and the University of Michigan. How can you get more information about the study? Please contact Robert Domeier, MD, Principal Investigator, at St. Joseph Mercy Hospital. E-mail: domeierr@trinity-health.org Phone: 734-712- 4289 Fax: 734-712-5178 4
Mailing address: Department of Emergency Medicine Administration Building 1B-95 5301 East Huron River Drive Ann Arbor, MI 48106 The St. Joseph Mercy Health System Institutional Review Board can be reached at 734-712- 3283. The following questions provide infomration on CPR in general. What is cardiac arrest? Cardiac arrest occurs when the heart suddenly stops. The heart may stop for a number of reasons, including heart attack, drowning, or choking. How many people experience cardiac arrest? Each year about 500,000 people in the United States experience cardiac arrest. About 350,000 (70 percent) of those cardiac arrests occur outside of a hospital. What's the immediate treatment for a cardiac arrest? Cardio-pulmonary resuscitation (CPR) is the first line of treatment. However, CPR is not very effective. The vast majority of patients who suffer cardiac arrest do not survive, despite the expertise and highly developed skills of EMS (Emergency Medical Service) providers (firefighters, paramedics and emergency medical technicians) and physicians. The survival rate for cardiac arrest patients in Washtenaw and Livingston counties is about 8 percent. The survival rate nationally, is 5 to 10 percent. What is CPR and how does CPR work? CPR is an emergency technique 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 compressions), 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. Why isn't CPR as effective as it might be? There are many reasons why the survival rate from cardiac arrest is so low. 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 available today for use by EMS providers. Sometimes the brain or neurologic function is damaged due to the lack of oxygen before CPR begins. How can the survival rate be improved? In an effort to improve the current poor outcome of patients after cardiac arrest, (survival rates between 5 and 10 percent) a new technique has been developed to hopefully improve the desired effect and success rate of CPR. 5