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

ABSTRACT:

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.

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 on

SUBMITTER: Aufderheide TP 

PROVIDER: S-EPMC3797446 | biostudies-literature | 2008 Aug

REPOSITORIES: biostudies-literature