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

被引：40

作者：

Aufderheide, Tom P. ^{[1
]}

Kudenchuk, Peter J. ^{[1
]}

Hedges, Jerris R. ^{[1
]}

Nichol, Graham ^{[1
]}

Kerber, Richard E. ^{[1
]}

Dorian, Paul ^{[1
]}

Davis, Daniel P. ^{[1
]}

Idris, Ahamed H. ^{[1
]}

Callaway, Clifton W. ^{[1
]}

Emerson, Scott ^{[1
]}

Stiell, Ian G. ^{[1
]}

Terndrup, Thomas E. ^{[1
]}

机构：

[1] Univ Ottawa, Ottawa, ON, Canada

来源：

RESUSCITATION | 2008年 / 78卷 / 02期

关键词：

cardiac arrest; sudden death; impedance threshold device; CPR;

D O I：

10.1016/j.resuscitation.2008.01.028

中图分类号：

R4 [临床医学];

学科分类号：

1002 ; 100602 ;

摘要：

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 evatuable 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. (C) 2008 Elsevier Ireland Ltd. All rights reserved.

引用

页码：179 / 185

页数：7

共 34 条

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