1	The ROC PRIMED Study
2	What is ROC? The Resuscitation Outcomes Consortium (ROC) There are 11 sites & 1 coordinating center between the U.S. and Canada ROC was created to study treatments that may help people with cardiac arrest or severe injury before they arrive at a hospital. ROC investigators work with Emergency Medical Services (EMS) Systems (our 911 system and paramedics)
3	What is PRIMED? Prehospital Resuscitation Using an IMpedance Valve & Early vs. Delayed Analysis (PRIMED) Trial A prehosptial study of two methods that may improve the procedures used by ambulance and fire personnel to deal with cardiac arrest Impedance Threshold Device (ITD) Early vs. Delayed Analysis of Heart Rhythms Since the persons treated will not be able to provide informed consent, the study will operate under a rule known as “exception to informed consent”
4	What is a heart attack? A heart attack happens when blood cannot get to the heart, usually because its path to the heart is blocked. If blood cannot get to the heart, the heart muscle cells are injured and die. When heart muscle cells die, disability or death can occur Other names for a heart attack Acute Myocardial Infarction (AMI) Coronary Thrombosis Coronary Occlusion
5	What is a cardiac arrest? Unlike a heart attack, in cardiac arrest, your heart stops beating Blood stops flowing through your body Your brain is starved of the oxygen it needs to work You stop breathing Death will occur without fast treatment
6	Cardiac Arrest Facts Over 180,000 people suffer from out-of-hospital cardiac arrest each year in the United States. Cardiac arrest survival is low. National estimates for surviving cardiac arrest are about 5%. New research suggests CPR has a much greater role in cardiac arrest survival than earlier thought. Other research suggests that an impedance threshold device (ITD) may improve outcome
7	Unanswered Questions Do devices that improve blood flow during CPR improve outcomes from cardiac arrest? Is it better to do a lot of CPR or a little CPR before shocking the heart?
8	What is CPR? CPR (Cardiopulmonary Resuscitation) is a technique that is used to maintain blood flow to the heart and brain during cardiac arrest by putting direct pressure on the heart, which ‘squeezes’ the heart and pushes blood through it. CPR technique principles Airway opening Chest compressions Breathing assistance
9	Part 1: Impedance Threshold Device
10	Understanding the ITD The ITD creates a vacuum by preventing air from entering the chest. It increases amount of blood returning to the heart. It increases forward blood flow with the next chest compression
11	‘Priming the Pump’
12	Part 2: Early vs. Late Check of Heart Rhythms
13	What would happen if I were enrolled in this study? The medics would treat you in pretty much the same way if you were in the ROC study, but two things would be different: 1. You might be randomly chosen to receive a real ITD—OR—a device that looks like, but does not act like, a real device. 2. You might be randomly chosen to be given 30 seconds of CPR—OR—3 minutes of CPR, before a decision to “shock” the heart with electricity is made.
14	Potential Risks & Benefits Potential Risks & Benefits Associated with the Use of the ITD In earlier studies involving 922 patients: Ø 16% survived to hospital admission without the ITD Ø 23% survived with the ITD No adverse events were reported. So it appears that the ITD may have significant benefits, and that any possible serious side effects are infrequent (probably less than 1 out of every 1000 or so patients).
15	Potential Risks & Benefits Potential Risks & Benefits Associated with the Use of the ITD The reason this study is being conducted is that we do not know about the long-term effects of the ITD. In the long term, the ITD could be helpful, harmful, or have no effect on how long, after hospitalization, someone survives following a cardiac arrest. Similarly, the ITD could make a person's quality of life following a cardiac arrest better, worse, or have no effect. The main concern about quality-of life is whether patients would suffer brain damage that impairs their ability to think, take care of themselves, or interact with other people. If negative effects on either length of life or quality of life begin to show up, the study will be ended.
16	Potential Risks & Benefits Potential Risks & Benefits of Differing Lengths of CPR In different communities, CPR may be done for as little as 30 seconds and as long as three minutes before a cardiac arrest patient is given an electrical shock to restart the heart. But we don’t really know which of these may be better. The only way to tell is to compare the two delays scientifically. The potential benefits of this part of the study would be knowing which approach is better in helping cardiac arrest patients to survive. There appear to be no significant risks to the systematic administration of CPR for a set length of time. Different communities already use different approaches with no apparent ill effects.
17	What is exception to informed consent?
18	Study Considerations, rules and regulations WHY HERE? The Portland/Vancouver Metro area was chosen partly based on our prior success with conducting high-quality prehospital EMS research, such as the PAD Trial
19	Closing Questions: Was there anything in the presentation that was confusing to you or that you think would be confusing to others in your community? Do you have any concerns of what you heard about the study? Based on what you heard, what do you think are the key points that need to be communicated to people in your community? What would you say about the need to enroll people in the study without being able to ask them for their consent?
20	Closing Questions Continued… What would you tell others about the risks of participating in this study? Are there any other risks that we may not have thought of? What would you say about the benefits of conducting the study? Do you think the potential benefits from the study outweigh the risks? Is there any other information about the risks and benefits that you need?
21	You Can Help… As part of the community notification process, we need to hear from as many people as possible about this research. Talk to your friends and neighbors or others who may be interested in learning more, and refer them to our website at: www.ohsu.edu/emergency/roc OR have them call 503-494-7015 to learn more about this research.
22	Questions…