ROC - PRIMED
Frequently Asked Questions (Page 2)
ROC PRIMED Questions and Answers
Where was ROC PRIMED conducted?
The study took place at 10 locations across the U.S. and Canada. Approximately 150 EMS and fire services organizations, involving more than 20,000 EMS providers who serve a combined population of nearly 15 million people from diverse urban, suburban, and rural regions participated in ROC PRIMED.
Why was the ROC PRIMED study enrollment stopped?
The study's independent safety oversight panel, the Data and Safety Monitoring Board (DSMB) recommended that the study end enrollment early because adding more patients appeared unlikely to alter the outcome. Preliminary results from the Analyze Early, Analyze Later testing indicate that neither strategy improved or decreased patient survival rates. Both methods appear to be equally helpful for patients. The testing of the ITDs, which are relatively new devices not yet widely used, showed no improvement or decrease in patient survival rates, according to preliminary results. Further analysis may yield additional insights. In both circumstances, there were no patient safety concerns.
When did the study stop enrollment?
Investigators could continue to enroll new patients until Nov. 6, 2009. The DSMB made their recommendation to stop the study on Oct. 23, 2009 after reviewing interim data analyses. Researchers began ending enrollment on Oct. 28, 2009.
How many patients were enrolled?
Approximately 11,500 patients were enrolled in ROC PRIMED. The first ROC PRIMED patient was enrolled June 7, 2007, and Nov. 6, 2009 was the last day investigators could enroll new patients.
What does neurologically intact survival mean?
Patients with preserved neurologic function are able to carry out activities of daily living. In contrast, patients who suffer neurological damage following cardiac arrest may no longer be able to care for themselves due to injury to parts of the brain.
Were there any deaths as a result of study participation?
Some cardiac arrest patients died before reaching the hospital or at the hospital, but there is no evidence that anyone died because they were part of the study. All participants received standard emergency care from EMS providers, with some patients randomly selected to also receive the intervention to be tested. Part of the reason for the study is that most patients (90 to 95 percent) who suffer cardiac arrest outside of a hospital setting do not survive. Researchers are seeking interventions that could improve survival rates.
What do the results of the study mean?
The preliminary results of the study indicate that a small amount of CPR (30-90 seconds) is just as effective as a longer period of CPR (approximately three minutes) before EMS providers analyze heart rhythm to determine the need for defibrillation when performing CPR. The method of analyzing heart rhythm after 30-90 seconds of CPR is just as beneficial as performing CPR for up to three minutes before analyzing heart rhythm. Both methods are in widespread use depending on the common practice of individual organizations. Use of the ITD did not improve or decrease survival rates of study participants. The novel device is not yet in widespread use.
When will the final study results be available?
ROC PRIMED investigators are analyzing the data and will prepare a report for publication to be submitted for peer review. We hope to have the final results published in the coming months. Some study participants may be followed for up to 6 months following their enrollment in the study, if they agree to be monitored. This data would be included in the final study results.
- Resuscitation Outcomes Consortium: https://roc.uwctc.org/tiki/tiki-index.php
- Sudden Cardiac Arrest: http://www.nhlbi.nih.gov/health/dci/Diseases/scda/scda_whatis.html
Results were published in the New England Journal of Medicine on September 1, 2011.
Cardiac Arrest and the Limitations of Clinical Trials
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A Trial of an Impedance Threshold Device in Out-of-Hospital Cardiac Arrest
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Early versus Later Rhythm Analysis in Patients with Out-of-Hospital Cardiac Arrest
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