ROC - PRIMED
Overview (page 3)
Potential Risks & Benefits Associated with Use of the ITD
In earlier studies involving 922 patients, 16% survived to hospital admission without the ITD, and 23% survived with the ITD. No adverse events were reported. So it appears that the ITD has significant benefits, and that any possible serious side effects are infrequent (probably less than 1 out of every 1000 patients or so).
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.
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.
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Study ResultsResults were published in the New England Journal of Medicine on September 1, 2011.
Cardiac Arrest and the Limitations of Clinical Trials
Read the Editorial
A Trial of an Impedance Threshold Device in Out-of-Hospital Cardiac Arrest
Read the Article
Early versus Later Rhythm Analysis in Patients with Out-of-Hospital Cardiac Arrest
Read the Article
Additional InformationIf you do not want to participate
Frequently Asked Questions