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What is this new technique and how does it work?
Researchers are testing two new investigational devices - the ResQ Pump and ResQ Pod. The ResQ Pump 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 ResQ Pod is a one-way valve located between the airbag (used to transport air into the lungs of the cardiac arrest patient) 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 creates 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:
However, none of these benefits are guaranteed.
Why are we doing this study?
The ResQ Pod and ResQ Pump have been successfully used on humans in Europe and showed an increase in the amount of blood circulated during CPR, but more study is needed. This will be the first study in the United States investigating the use of the chest compression/decompression and breathing valve devices together.
How will the study be conducted?
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. Over the course of about three years, 3,100 patients will be enrolled in this study. The study will include three treatment groups:
The U.S. Food and Drug Administration (FDA) and the Human Investigation Committee at Beaumont Hospital (in addition to the Institutional Review Boards at other area hospitals) have approved this study in Oakland and Macomb counties. Approval has also been granted by the Medical Control Authorities of Oakland and Macomb counties, who oversee the EMS providers.
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?
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. There may be other unknown or unanticipated discomfort or risks from using the valve.
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 patients. Rib fractures, if they occur, sometimes make it more difficult for the chest to expand and use of the ResQ Pump may help facilitate that.
How are cardiac arrest victims and their families informed about this research?
Obtaining an "informed consent" from patients suffering a cardiac arrest is nearly 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, or 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:
When a cardiac arrest patient 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 full informed consent. You may choose not to participate and if so your data will not be used, or to withdraw from the study at any time, without penalty or loss of 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 evaluate 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 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, this planned emergency research study on out-of-hospital cardiac arrest sufferers meets these requirements:
Will the cardiac arrest patient's family 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 cardiac arrest 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. 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 William Beaumont Hospital, St. John Health (Providence Hospital, St. John Oakland Hospital, St. John Macomb Hospital), Crittenton Hospital Medical Center, St. Joseph Mercy Oakland and St. Joseph Mercy of Macomb.
How can you get more information about the study?
Please contact Robert A. Swor, D.O., Principal Investigator at Beaumont, Royal Oak.
E-mail: firstname.lastname@example.orgPhone: 248-898-1970 Fax: 248-898-2017
Department of Emergency MedicineBeaumont Hospital3601 W. Thirteen Mile RoadRoyal Oak, MI 48073
The William Beaumont Hospital Human Investigation Committee/Institutional Review Board can be reached at 248-551-0662.
The following questions provide information 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. One to two people per 1,000 suffer a cardiac arrest each year.
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 Oakland County is 7.2 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.