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What is cardiac arrest?
Cardiac arrest is a serious medical condition. During a cardiac arrest the heart stops beating effectively and is unable to pump blood to the organs of the body. It usually occurs suddenly and unexpectedly. Death can occur within minutes unless treatment is started.
What is an out-of-hospital cardiac arrest?
Cardiac arrest can happen any place. If the cardiac arrest occurs outside of the hospital, it is referred to as an out-of-hospital cardiac arrest.
What is the incidence of out-of-hospital cardiac arrest?
Cardiac arrest is one of the most common killers of Americans each year. Statistics indicate that cardiac arrest may kill anywhere from 180,000 up to 450,000 people annually in the US.
What causes a cardiac arrest?
The most common underlying reason for patients to die suddenly from cardiac arrest is coronary heart disease. These people are at varying risks for cardiac arrest. In general, those with damaged hearts are at greater risk. Specific risk factors include a previous episode of cardiac arrest, a history of heart failure and a family history of sudden cardiac arrest. Other factors besides heart disease can cause cardiac arrest. They include respiratory arrest, electrocution, drowning, choking and drug overdoses. Cardiac arrest can also occur without any identifiable cause.
What is the treatment for out-of-hospital cardiac arrest?
The first step in the treatment of an out-of-hospital cardiac arrest is quick identification of the problem. This can be done by checking for signs of life (consciousness, movement, normal breathing). Once a cardiac arrest is confirmed, quick access to the 911 system is essential. The standard treatment for cardiac arrest is immediate CPR, which can be started by citizens before emergency medical services providers are on the scene. Once the emergency medical providers are on scene they continue CPR. Many times an electrical shock or shocks are given to the heart to try and restore a normal heartbeat. This electrical shock is called defibrillation. Other procedures to treat patients in cardiac arrest are the placement of electrodes to monitor the heart’s electrical rhythm, the placement of an intravenous line (needle into the vein) to give fluids and medications, and the placement of an endotracheal tube (tube into the lungs) to provide breathing.
How does CPR help?
During a cardiac arrest, while the heart no longer pumps blood and the organs of the body no longer receive oxygen so begin to die. CPR consists of pumping on the patient’s chest and delivering breaths to produce some circulation until the heart can be restarted. When the chest is compressed, oxygen-rich blood is pumped forward. When the chest is released, oxygen-poor blood is brought back to the heart where it can be restored with oxygen before being pushed out to the body with another compression. Both actions – pushing oxygen-rich blood forward and bringing oxygen-poor blood back to the heart - are important. CPR produces some blood flow – but only about 30% of normal circulation. Methods to improve the circulation produced by CPR may lead to better survival.
How does the Impedance Threshold Device increase blood flow during CPR?
The Impedance Threshold Device or “ITD” is a device smaller than your fist that attaches to the end of the breathing bag or breathing tube used by emergency medical technicians (EMTs) and paramedics. The ITD works to increase the vacuum effect when the chest is released during CPR. We believe that by increasing the vacuum effect, chest release, also called decompression, during CPR brings more oxygen-poor blood back to the heart so that ultimately more oxygen-rich blood is available to be pushed forward. In one study, the ITD produced better circulation and more patients were able to regain their own natural heartbeat. But we don't know for sure that using the ITD will be beneficial.
What is the effect of CPR before shocking the heart?
Evidence indicates that an electrical shock applied early after cardiac arrest helps restart the heart so that common practice has set the shock as the first priority when trying to restart the heart. When a shock is given to the heart during cardiac arrest, it resets the abnormal heart rhythm but does not necessarily start blood circulating again. Some more recent evidence indicates that delaying the shock to provide CPR may provide a better chance for the heart to regain its own natural heart beat. CPR seems to fill the heart with oxygen-rich blood so that when the heart rhythm is reset with the shock, normal circulation can be restored. This circumstance may be especially the case if the patient has been collapsed for more than 5 minutes. But we don't know for sure which way of doing CPR is better.
Who will be eligible to be enrolled in the study?
All adult subjects (over age 18 years) treated by Seattle or King County Emergency Medical Service (EMS) for a cardiac arrest during the study period may be eligible. The cardiac arrest cannot be due to trauma such as a gunshot wound, stabbing, or severe motor vehicle accident.
How will the study decide which treatment is provided?
As part of the study, a person suffering cardiac arrest in Seattle and King County may be treated by Emergency Medical Services providers with the impedance threshold device, CPR before the shock, both, or neither (regular care). There is a chance of receiving any one of these treatment approaches. We believe that this type of study, called a randomized trial, will give us the clearest answer about the best approach for the treatment of cardiac arrest.
How will the study affect care after admission to the hospital?
All study treatments will have been given before hospitalization. After admission to the hospital, no study treatments will be given. All persons will receive standard care by their health care providers in the hospital regardless of whether they were a part of this study or not.
Will the study affect care after discharge from the hospital?
All study treatments will have been given before hospitalization. No study treatments will be given thereafter. At hospital discharge subjects will be asked to consent to take part in a telephone interview that will evaluate their recovery from cardiac arrest at 1, 3 and 6 months. Participation in this telephone follow-up is strictly voluntary.
Who is supporting the study?
The study is supported by the National Institute of Health
Are other communities participating?
Yes, a total of 11 communities from the US and Canada are participating. More information about the collaboration of communities to help learn more about treatment of cardiac arrest is available at (CTC Web site).
How long will the study take?
Once underway, the study will take about 2 years to complete.
Who are the investigators for the study?
Investigators from the University of Washington and Harborview Medical Center in collaboration with the Emergency Medical Services agencies of Seattle and King County will conduct the study.
How is the study being supervised?
We take the responsibility of conducting this kind of research very seriously.
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Seattle-King County and all other participating sites were selected for this study based on their prior success at conducting high-quality out-of-hospital emergency care research. An experienced team of physician investigators and nurse coordinators will be supervising highly trained emergency medical responders (emergency medical technicians and paramedics) throughout the trial.
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Prior evaluation of the treatments being provided in this study holds out the promise of their success over current standard treatments.
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This study was reviewed for its merit and safety, and approved by an independent committee appointed by the National Institutes of Health.
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This study was reviewed and approved by the U. S. Food and Drug Administration (FDA) and will continue to be monitored by the agency throughout the study
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Specific regulations developed by the FDA must be followed in this study. These regulations require that the community where the research is being conducted be notified and consulted before the research is started, and later notified of the results of the study. All enrolled subjects must also be notified of their participation and have the study explained to them as soon as it is feasible to do so.
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Another independent group, including experts in medicine, ethics, statistics and clinical trial methods, called a Data Safety Monitoring Board (DSMB) has been appointed by the government to monitor the safety of the patients throughout the course of the study. This group has access to the study outcome information and can recommend changes, including stopping the study at any time if there is any indication of safety issues, if the study is not progressing as planned, or if results from one particular treatment are extremely favorable.
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An independent Human Subjects Review Committee at the University of Washington, comprised of scientists and lay representatives from our community, is evaluating the procedures in this study to insure that all appropriate conditions have been met and the safety and confidentiality of all enrolled subjects insured. The study will not begin until this group has given their final approval.
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Any adverse events during the study must be immediately reported to the Human Subjects Review Committee, the DSMB and FDA.
What about consent for the study?
The CPR study is being done under “waiver of consent”. This means subjects are enrolled in the study without their prior consent. Federal regulations usually do not allow patients to be enrolled in a study without their informed consent or without the consent of their next of kin. However, in certain limited situations, such as emergency medicine research, the U. S. Food and Drug Administration (FDA) does allow some studies to be conducted without prior consent. In order to be able to do a study using “waiver of consent” the following requirements established by the FDA must be met.
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The study involves a life-threatening situation with unproven or unsatisfactory treatment where research is necessary to improve outcome.
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Obtaining informed consent is not feasible because the patient is unresponsive and treatment must begin immediately.
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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.
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The research could not practicably be done without waiver of informed consent.
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The potential therapeutic window is short (in the case of cardiac arrest, treatment needs to be given within minutes).
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The researchers must develop informed consent procedures they will implement when it is possible to obtain consent.
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An Institutional Review Board (IRB) must approve the study.
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A Data Safety Monitoring Board must regularly evaluate the study for safety.
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Consultation and public disclosure with the community about the research has been conducted.
After treatment, the medical record of subjects pertaining to their cardiac arrest will be reviewed by investigators to evaluate the safety and effectiveness of the study treatments received. The review involves little or no risk to the privacy of the subject.
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Does not adversely affects the rights and welfare of the subjects.
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Will not affect the care of the subject nor deprive them or normal clinical care.
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The research could not be carried out without review of records or without waiver of consent.
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The benefit of evaluating the safety and effectiveness of the treatment outweighs any risks to subjects.
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The privacy of health information of subjects is protected.
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All subjects are notified and informed about their participation in the research.
Community consultation is also required before any study can be done using a waiver of consent. The purpose of this consultation is to make sure the community wishes to participate in the study and that any concerns about that participation are addressed. 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:
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This website
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Press releases
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Consultation with community organizations
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Community survey (using random digit telephone dialing)
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Written brochures explaining the research, available upon request
In addition, we plan to provide information to the community regarding progress of the trial and its results, once those are available. This will be done through this website and press releases.
The investigators, with oversight by an independent Human Subjects Review Committee at the University of Washington, will take steps to insure that all of these conditions have been satisfied for this research.
How will I know if my relative or I was enrolled in the study?
You or your legally authorized representative will be notified soon after enrollment into the study and provided information about it. In addition, we plan to provide information to the community regarding progress of the trail and its results, once those are available. This will be done through this website and press releases.
How will enrolled subjects’ medical information be kept confidential?
By law, researchers must protect the privacy of health information about subjects. We make every effort to keep the information confidential. All subjects enrolled in the trial will be assigned a code number. This code number is used on any data we collect. A key linking the subject to the code number is kept locked in a secure location and will be available only to the investigators. Once this study is completed this key will be destroyed. In addition, all investigatros have signed a Confidentiality Agreement to protect the privacy of health information about subjects.
Who are the investigators for the study?
Principal Investigator:
Peter J. Kudenchuk, MD
Professor of Medicine
Division of Cardiology
University of Washington
Co-investigators:
Tom Rea, MD
Associate Professor Of Medicine
Division of General Medicine
Harborview Medical Center
Medical Director: King County Medic One
Public Health – Seattle & King County
Mickey Eisenberg, MD
Professor of Medicine
Division of Emergency Medicine
University of Washington
Medical Director: King County Emergency Medical Services
Public Health – Seattle & King County
How can I get more information about the study?
Please call Sally Ragsdale RN or Debi Solberg RN, Research Coordinators, with any questions or comments regarding the CPR study.
Phone:
206-447-5671 or 1-800-607-2926.
E-mail: kcroc@u.washington.edu
PLEASE NOTE WE CANNOT GUARANTEE THE CONFIDENTIALITY OF E-MAIL CORRESPONDENCE
Address
Resuscitation Outcomes Consortium (ROC)
600 9th Avenue, #103
Seattle, WA 98104
Published Studies
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Aufderheide TP, Pirrallo RG, Provo TA, Lurie KG. Clinical evaluation of an inspiratory impedance threshold device during standard cardiopulmonary resuscitation in patients with out-of-hospital cardiac arrest. Crit Care Med. 2005 Apr;33(4):734-40.
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Cobb LA, Fahrenbruch CE, Walsh TR, Copass MK, Olsufka M, Breskin M, Hallstrom AP. Influence of cardiopulmonary resuscitation prior to defibrillation in patients with out-of-hospital ventricular fibrillation. JAMA. 1999 Apr 7;281(13):1182-8.
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Wik L, Hansen TB, Fylling F, Steen T, Vaagenes P, Auestad BH, Steen PA. Delaying defibrillation to give basic cardiopulmonary resuscitation to patients with out-of-hospital ventricular fibrillation: a randomized trial. JAMA. 2003 Mar 19;289(11):1389-95.
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Jacobs IG, Finn JC, Oxer HF, Jelinek GA. CPR before defibrillation in out-of-hospital cardiac arrest: a randomized trial. Emerg Med Australas. 2005 Feb;17(1):39-45.
What does it mean to opt-out of this study?
If you do not want to participate in this study you can request to “opt-out.” If you choose to opt-out we will mail you a Medic-Alert type bracelet with the words “No Study” engraved on it. You will have to wear this bracelet during the time the study is being conducted – through 2010. Even if you wear this bracelet there is no guarantee that under emergency circumstances the bracelet will be read by those providing care for you. You might still get the enrolled in the study. In the unlikely event you are treated in this trial after you have requested to not be enrolled we will not use any of the information collected about you; such information will be destroyed.
How can I opt-out of this study?
If you would like to opt-out of participation in this trial please send your request to the following email address: kcroc@u.washington.edu. Be sure to include your name and mailing address so we can mail you the opt-out bracelet.