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

Research output: Contribution to journalArticlepeer-review

41 Scopus citations

Abstract

Objective: The primary objective of the trial is to compare survival to hospital discharge with modified Rankin score (MRS) ≤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. Methods: Design-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 ≤3 rate from 5.41% after Analyze Early to 7.45% after Analyze Later (2.04% absolute increase in primary outcome). Conclusion: If 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.

Original languageEnglish (US)
Pages (from-to)186-195
Number of pages10
JournalResuscitation
Volume78
Issue number2
DOIs
StatePublished - Aug 2008

Keywords

  • CPR
  • Cardiac arrest
  • Defibrillation
  • Prehospital

ASJC Scopus subject areas

  • Emergency Medicine
  • Emergency
  • Cardiology and Cardiovascular Medicine

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