Resuscitation Outcomes Consortium (ROC) PRIMED cardiac arrest trial methods. Part 1: Rationale and methodology for the impedance threshold device (ITD) protocol

Tom P. Aufderheide, Peter J. Kudenchuk, Jerris R. Hedges, Graham Nichol, Richard E. Kerber, Paul Dorian, Daniel P. Davis, Ahamed H. Idris, Clifton W. Callaway, Scott Emerson, Ian G. Stiell, Thomas E. Terndrup

Research output: Contribution to journalArticle

40 Scopus citations

Abstract

Aim: The primary aim of this study is to compare survival to hospital discharge with a modified Rankin score (MRS) ≤ 3 between standard cardiopulmonary resuscitation (CPR) plus an active impedance threshold device (ITD) versus standard CPR plus a sham ITD in patients with out-of-hospital cardiac arrest. Secondary aims are to compare functional status and depression at discharge and at 3 and 6 months post-discharge in survivors. Materials and methods: Design: Prospective, double-blind, randomized, controlled, clinical trial. Population: Patients with non-traumatic out-of-hospital cardiac arrest treated by emergency medical services (EMS) providers. Setting: EMS systems participating in the Resuscitation Outcomes Consortium. Sample size: Based on a one-sided significance level of 0.025, power = 0.90, a survival with MRS ≤ 3 to discharge rate of 5.33% with standard CPR and sham ITD, and two interim analyses, a maximum of 14,742 evaluable patients are needed to detect a 6.69% survival with MRS ≤ 3 to discharge with standard CPR and active ITD (1.36% absolute survival difference). Conclusion: If the ITD demonstrates the hypothesized improvement in survival, it is estimated that 2700 deaths from cardiac arrest per year would be averted in North America alone.

Original languageEnglish (US)
Pages (from-to)179-185
Number of pages7
JournalResuscitation
Volume78
Issue number2
DOIs
StatePublished - Aug 1 2008

Keywords

  • CPR
  • Cardiac arrest
  • Impedance threshold device
  • Sudden death

ASJC Scopus subject areas

  • Emergency Medicine
  • Emergency
  • Cardiology and Cardiovascular Medicine

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    Aufderheide, T. P., Kudenchuk, P. J., Hedges, J. R., Nichol, G., Kerber, R. E., Dorian, P., Davis, D. P., Idris, A. H., Callaway, C. W., Emerson, S., Stiell, I. G., & Terndrup, T. E. (2008). Resuscitation Outcomes Consortium (ROC) PRIMED cardiac arrest trial methods. Part 1: Rationale and methodology for the impedance threshold device (ITD) protocol. Resuscitation, 78(2), 179-185. https://doi.org/10.1016/j.resuscitation.2008.01.028