‘The survival rates for patients suffering from cardiac arrest before reaching a medical facility are tragically low,’ said Susan Shurin, MD, deputy director of the NHLBI, which oversees clinical trials supported by the NHLBI and accepted the recommendation of the DSMB . ‘This study provides important evidence to help inform the rescue workers and other health professionals on safe and effective treatment options to save lives we will continue to seek new ways to save lives in precious moments following a cardiac arrest -. And to assess the benefits and risks of commonly used practices. ‘For patients randomly assigned to the group of initial analysis, EMS providers were instructed to perform CPR until they are able to analyze the patient’s heart rhythm . Patients in analysis after the group received CPR for at least three minutes before their heart rate was analyzed. When indicated, defibrillation was provided.
After examining data on approximately 11,500 study participants, data from the study of safety monitoring board has recommended that the October 23 NHLBI stopped enrollment because sufficient data were collected, and continuing recruitment was unlikely to change the overall results of the study. Researchers continue to monitor the study participants who agree to follow-up visits for six months. They analyze and publish the final data in the coming months. The NHLBI is part of the National Institutes of Health.
‘The DRC is the largest research network to study interventions in the real world, pre-hospital cardiac arrest,’ said George Sopko, MD, ROC project manager, Division of Cardiovascular Sciences of the NHLBI. ‘The completion of these studies through a network of experts robust and allows us to apply and compare a significant clinical interventions and disseminate the results as quickly as possible so they can be applied to improve public health.’
Approximately 150 EMS and fire service organizations, involving more than 20,000 EMS providers who serve a population of over 15 million people in different urban, suburban and rural areas participated in the ROC began. ROC research focuses on treatments for patients with fatal traumatic injury or cardiac arrest in the parameters of the real world, usually where the collapse of the patients or seriously injured, before they reach the hospital. Participating EMS providers receive intensive training, and provide emergency care standards for all patients, with some patients randomly selected to receive the intervention to be tested in addition to usual care.
The Resuscitation Outcomes Consortium , the largest network of clinical research to study the treatment of pre-hospital cardiac arrest in the United States and Canada, tested two resuscitation strategies as part of pre-hospital resuscitation through a valve impedance and early or Delayed clinical trial. An impedance valve, also called an impedance threshold device , is a small hard plastic device about the size of a fist that is attached to the mask or breathing tube during CPR administered by EMS providers. The unit is designed to improve circulation, improving changes in pressure within the chest during CPR.
‘While the ITD is based on sound physiological principle, in this study, it seems to improve the survival rate of adults in cardiac arrest outside the hospital,’ said Tom Aufderheide, MD, Professor of Emergency Medicine Medical College of Wisconsin Milwaukee and a Principal Investigator ROC. ‘We will continue to seek out and thoroughly test new devices and applications promising alternatives to save the lives of patients in cardiac arrest.’
Earlier this year, the NHLBI stopped enrollment for the first two clinical studies that have examined the ROC when concentrated improved survival compared with normal physiological saline for trauma patients. Patients in the study were either in shock due to blood loss or had suffered a traumatic brain injury. In both types of patients, hypertonic saline did not improve the results on the use of a standard saline solution.
Triggered ROC ROC and other clinical trials are conducted under strict FDA guidelines that allow patients to U.S. and Canadian life-threatening situations to participate in research of an explicit exception to informed consent in accordance with the U.S. and Canada. This is necessary because, among other things, participants in a cardiac arrest are unconscious and therefore can not give consent.
ROC PRIMED was designed to test two promising strategies to increase the chances of survival without functional problems of patients who suffer cardiac arrest outside the hospital. To test the ITD strategy, patients were randomized to receive CPR level of participation by EMS providers or an ITD or a non-working replica of the DTI.
Myron Weisfeldt, MD, president of the ROC Steering Committee and Director of the Department of Medicine, Johns Hopkins University of Medicine in Baltimore, said: ‘Questions like this – that address the merits of current medical practices – are an important example of comparative effectiveness research and, if so, can contribute to emergency medical care first. ‘
Some small studies have suggested that long periods of CPR before defibrillation may improve survival, while other studies have suggested that the most immediate defibrillation – when the patient is treated within two minutes after the start of Judgement heart – perhaps better.
To ensure the safety of patients during the study, the DSMB that monitors ROC studies to review the accumulated data about every six months or more frequently if necessary. In its review of preliminary data on October 23, the DSMB recommended stopping enrollment ROC PRIMED both assessments on the basis of the results suggest that both strategies were equally positive and continuous recording is unlikely that give different results. The NHLBI accepted the recommendation, and ROC clinical centers stopped enrollment.
However, a large human clinical study was needed to show whether the device significantly improves survival with preserved neurologic function. Patients with preserved neurologic function are able to perform activities of daily living. In contrast, patients with neurological disorders after cardiac arrest may no longer be able to take care of themselves due to injury to parts of the brain.
‘The ROC PRIMED study answers a long-standing issue of the community, EMS to see if it is better to defibrillate before or after, trying to resuscitate a patient,’ said Ian Stiell, MD, Professor and Director of the Department of Emergency Medicine at the ‘University of Ottawa, senior researcher at the Ottawa Hospital Research Institute and principal investigator for the ROC PRIMED Analyze early vs. late protocol. ‘The two techniques seem to be equally useful.’
Registration is completed at the beginning of the multi-center clinical comparison of two large distinct strategies for resuscitation delivered by emergency medical services to increase blood flow during cardiac arrest. Board of Directors of independent study and monitoring the National Heart, Lung, and Blood Institute , the main sponsor of the study stopped enrollment based on preliminary data suggest that neither strategy significantly improved survival.
Strategy compared different durations of manual cardiopulmonary resuscitation by EMS providers before assessing whether defibrillation is needed, and the other strategy tested the potential benefits and risks of an experimental device to maintain the pressure in the chest during CPR .