Resuscitation Outcomes Consortium (ROC) PRIMED cardiac arrest trial methods part 1: rationale and methodology for the impedance threshold device (ITD) protocol. Resuscitation 2008 Aug;78(2):179-85
Date
05/20/2008Pubmed ID
18487005Pubmed Central ID
PMC3797446DOI
10.1016/j.resuscitation.2008.01.028Scopus ID
2-s2.0-46649107300 (requires institutional sign-in at Scopus site) 46 CitationsAbstract
AIM: 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.
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< 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).
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.
Author List
Aufderheide TP, Kudenchuk PJ, Hedges JR, Nichol G, Kerber RE, Dorian P, Davis DP, Idris AH, Callaway CW, Emerson S, Stiell IG, Terndrup TE, ROC InvestigatorsAuthor
Tom P. Aufderheide MD Professor in the Emergency Medicine department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
Cardiopulmonary ResuscitationDouble-Blind Method
Electric Countershock
Emergency Medical Services
Heart Arrest
Humans
Patient Discharge
Prospective Studies
Survival Rate