A Trial of an Impedance Threshold Device in Out-of-Hospital Cardiac Arrest

Authors

Tom P. Aufderheide, Medical College of Wisconsin
Graham Nichol, University of Washington
Thomas D. Rea, University of Washington
Siobhan P. Brown, University of Washington
Brian G. Leroux, University of Washington
Paul E. Pepe, University of Texas Southwestern Medical Center at Dallas
Peter J. Kudenchuk, University of Washington
Jim Christenson, University of British Columbia
Mohamud R. Daya, Oregon Health & Science University
Paul Dorian, University of Toronto
Clifton W. Callaway, University of Pittsburgh
Ahamed H. Idris, University of Texas SW Medical Center Dallas
Douglas Andrusiek, University of British Columbia, British Columbia Emergency & Hlth Serv Commiss
Shannon W. Stephens, University of Alabama - Birmingham
David Hostler, University of Pittsburgh
Daniel Davis, University of California - San Diego
James V. Dunford, University of California - San Diego
Ronald G. Pirrallo, Medical College of Wisconsin
Ian G. Stiell, University of Ottawa
Catherine M. Clement, University of Ottawa
Alan Craig, Toronto Emergency Med Serv
Lois Van Ottingham, University of Washington
Terri A. Schmidt, Oregon Health & Science University
Henry E. Wang, University of Alabama - Birmingham
Myron L. Weistfeldt, John Hopkins Med Inst
Joseph P. Ornato, Virginia Commonwealth UniversityFollow
George Sopko, National Institutes of Health

Document Type

Article

Original Publication Date

2011

Journal/Book/Conference Title

The New England Journal of Medicine

Volume

365

DOI of Original Publication

10.1056/NEJMoa1010821

Comments

Originally Published at http://dx.doi.org/10.1056/NEJMoa1010821

Date of Submission

January 2015

Abstract

Background

The impedance threshold device (ITD) is designed to enhance venous return and cardiac output during cardiopulmonary resuscitation (CPR) by increasing the degree of negative intrathoracic pressure. Previous studies have suggested that the use of an ITD during CPR may improve survival rates after cardiac arrest.

Methods

We compared the use of an active ITD with that of a sham ITD in patients with out-ofhospital cardiac arrest who underwent standard CPR at 10 sites in the United States and Canada. Patients, investigators, study coordinators, and all care providers were unaware of the treatment assignments. The primary outcome was survival to hospital discharge with satisfactory function (i.e., a score of ≤3 on the modified Rankin scale, which ranges from 0 to 6, with higher scores indicating greater disability).

Results

Of 8718 patients included in the analysis, 4345 were randomly assigned to treatment with a sham ITD and 4373 to treatment with an active device. A total of 260 patients (6.0%) in the sham-ITD group and 254 patients (5.8%) in the active-ITD group met the primary outcome (risk difference adjusted for sequential monitoring, −0.1 percentage points; 95% confidence interval, −1.1 to 0.8; P=0.71). There were also no significant differences in the secondary outcomes, including rates of return of spontaneous circulation on arrival at the emergency department, survival to hospital admission, and survival to hospital discharge.

Conclusions

Use of the ITD did not significantly improve survival with satisfactory function among patients with out-of-hospital cardiac arrest receiving standard CPR. (Funded by the National Heart, Lung, and Blood Institute and others; ROC PRIMED ClinicalTrials.gov number, NCT00394706.)

Rights

From The New England Journal of Medicine, Aufderheide, T. P., Nichol, G., Rea, T.R. et al., A Trial of an Impedance Threshold Device in Out-of-Hospital Cardiac Arrest, Vol. 365, Page 798, Copyright © 2011 Massachusetts Medical Society. Reprinted with permission.

Is Part Of

VCU Emergency Medicine Publications