Resuscitation Outcomes Consortium (ROC) PRIMED cardiac arrest trial methods part 1: rationale and methodology for the impedance threshold device (ITD) protocol.
OBJECTIVE
The 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.


METHODS



METHODS
Prospective, double-blind, randomized, controlled, clinical trial.


METHODS
Patients with non-traumatic out-of-hospital cardiac arrest treated by emergency medical services (EMS) providers.


METHODS
EMS systems participating in the Resuscitation Outcomes Consortium.


METHODS
Based 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).


CONCLUSIONS
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.
Aufderheide
Tom P
TP
Milwaukee, WI, USA. taufderh@mcw.edu
Kudenchuk
Peter J
PJ
Hedges
Jerris R
JR
Nichol
Graham
G
Kerber
Richard E
RE
Dorian
Paul
P
Davis
Daniel P
DP
Idris
Ahamed H
AH
Callaway
Clifton W
CW
Emerson
Scott
S
Stiell
Ian G
IG
Terndrup
Thomas E
TE
D016887:Cardiopulmonary Resuscitation / Q000295:instrumentation*; D004311:Double-Blind Method; D004554:Electric Countershock / Q000295:instrumentation*; D004632:Emergency Medical Services / Q000379:methods*; D006323:Heart Arrest / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D006801:Humans; D010043:Outcome and Process Assessment, Health Care; D010351:Patient Discharge / Q000706:statistics & numerical data*; D011446:Prospective Studies; D015996:Survival Rate