OHSU DEPT OF EMERGENCY MEDICINE

ROC PRIMED Study

Resuscitation Outcomes Consortium: Prehospital Resuscitation IMpedance valve and Early vs Delayed analysis (ROC PRIMED) Trial

ROC PRIMED Study FAQ

Some EMS systems are already using the ITD. Why are you doing a study?
The ITD is currently approved by the FDA for use in low blood flow situations (such as patients who have a low blood pressure) but no studies were large enough to demonstrate if the chance of survival to hospital discharge is increased by using the ITD on patients in cardiac arrest.
Don’t we already know the answer about doing CPR before defibrillation?
Three studies have looked at this question. Two studies where CPR was performed before defibrillation showed positive results but one did not find any benefit. For many years the thought was that the best way to treat ventricular fibrillation was to immediately shock the heart. These studies have suggested that maybe a short period of CPR before the shock might actually improve the outcomes from the shock. Many EMS systems do not routinely perform sustained CPR before defibrillation.
Are there any risks to either of these treatments?
The risks associated with the use of ITD include that the device may not provide better blood flow than chest compressions without an ITD, not work as intended, increase the work of breathing (i.e. more work required by lungs) or increase fluid buildup in the lungs. Also there are risks associated with traditional manual chest compression done by EMS providers. These include possible rib fractures, pneumothorax (collapse of part of the lung), or a laceration of the liver (internal cut of the liver). However these risks would have been experienced regardless of whether an ITD was used. If the cardiac arrest is witnessed by an EMS provider, prior research has shown that an immediate shock appears to be more beneficial than doing CPR. For this reason we have excluded these patients from the randomized CPR portion of the study.
Why can’t consent be obtained before the treatment is given?
Patients who are in cardiac arrest are unconscious and their heart is not moving blood through the body and brain. CPR must be started almost immediately. Even with immediate treatment, most patients do not live. In this situation where the patient is unable to give consent, regulations to allow study of treatment for life-threatening conditions have been developed by the FDA to allow for an exception from (patient or family) consent.
Is it legal to conduct research on someone who cannot consent?
We take the responsibility of conducting this kind of research very seriously. First, the participating sites and coordinating center were selected based in part on their prior success at conducting high-quality prehospital emergency care research. Second, prior studies of the new treatment must hold out promise of success over the current standard of care. Third, the study was reviewed and approved by an independent committee of the National Institutes of Health before study initiation. Fourth, the study was reviewed and approved by the Food and Drug Administration before study initiation and will continue to be monitored for safety issues by the agency throughout the study. Fifth, the consent regulations developed by the FDA must also be followed. These regulations require that the community where the research is being conducted be notified and consulted with before the research is started. In addition, the community must also be notified of the results of the study. A local independent group called an Institutional Review Board is charged with determining the process of the community notification and consultation, reviewing the comments from the community and supervising the local study for safety and any other issues of concern.

Another independent group including experts in medicine, ethics, statistics, and clinical trial methods must also be appointed to monitor the safety of the patients throughout the course of the study. This is called a Data Safety Monitoring Board (DSMB). This group has access to the study outcome data and can recommend changes including stopping the study at any time if there is any indication of safety issues or that the study is not progressing as planned. All adverse events are reported to the DSMB and the FDA.

Patients and families are notified of their participation in the research as soon as feasible either in person, by phone or mail.
Who is funding the study?
The study is primarily funded through the National Heart, Lung and Blood Institute of the National Institutes of Health but further contributions have been made by National Institute of Neurological Disorders and Stroke, the Institute of Circulatory and Respiratory Health of the Canadian Institutes of Health Research, Institute of Circulatory and Respiratory Health, Defence Research and Development Canada and the Heart and Stroke Foundation of Canada, and the American Heart Association.
What are the potential benefits?
The benefits of the study are that blood may be more effectively circulated through the body and to the brain thus preserving vital organs. Also, it is believed that a short period of CPR prior to shocking the heart will result in more cases of a normal heart rhythm being restored after the shock.
Why do two treatments in one study?
Doing two treatments in one study allows us to expose fewer patients to study procedures while gaining the maximum amount of information. A typical study takes 2 or more years to conduct. Combining more than one intervention allows us to obtain answers more quickly thus bringing information to the community more quickly.

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Created by Jim Huie