• 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, and ROC Investigators.
• Milwaukee, WI, USA. taufderh@mcw.edu
• Resuscitation. 2008 Aug 1;78(2):179-85.

AimThe primary aim of this study is to compare survival to hospital discharge with a modified Rankin score (MRS)< or =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 MethodsDesignProspective, double-blind, randomized, controlled, clinical trial.PopulationPatients with non-traumatic out-of-hospital cardiac arrest treated by emergency medical services (EMS) providers.SettingEMS systems participating in the Resuscitation Outcomes Consortium.Sample SizeBased on a one-sided significance level of 0.025, power=0.90, a survival with MRS< or =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< or =3 to discharge with standard CPR and active ITD (1.36% absolute survival difference).ConclusionIf 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.

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