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Randomized Controlled Trial Multicenter Study Comparative Study
Resuscitation Outcomes Consortium (ROC) PRIMED cardiac arrest trial methods part 2: rationale and methodology for "Analyze Later vs. Analyze Early" protocol.
- Ian G Stiell, Clif Callaway, Dan Davis, Tom Terndrup, Judy Powell, Andrea Cook, Peter J Kudenchuk, Mohamud Daya, Richard Kerber, Ahamed Idris, Laurie J Morrison, Tom Aufderheide, and ROC Investigators.
- Ottawa, Ontario, Canada. istiell@ohri.ca
- Resuscitation. 2008 Aug 1;78(2):186-95.
ObjectiveThe primary objective of the trial is to compare survival to hospital discharge with modified Rankin score (MRS) < or =3 between a strategy that prioritizes a specified period of CPR before rhythm analysis (Analyze Later) versus a strategy of minimal CPR followed by early rhythm analysis (Analyze Early) in patients with out-of-hospital cardiac arrest.MethodsDesign-Cluster randomized trial with cluster units defined by geographic region, or monitor/defibrillator machine. Population-Adults treated by emergency medical service (EMS) providers for non-traumatic out-of-hospital cardiac arrest not witnessed by EMS. Setting-EMS systems participating in the Resuscitation Outcomes Consortium and agreeing to cluster randomization to the Analyze Later versus Analyze Early intervention in a crossover fashion. Sample size-Based on a two-sided significance level of 0.05, a maximum of 13,239 evaluable patients will allow statistical power of 0.996 to detect a hypothesized improvement in the probability of survival to discharge with MRS < or =3 rate from 5.41% after Analyze Early to 7.45% after Analyze Later (2.04% absolute increase in primary outcome).ConclusionIf this trial demonstrates a significant improvement in survival with a strategy of Analyze Later, it is estimated that 4000 premature deaths from cardiac arrest would be averted annually in North America alone.
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