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

Tom P. Aufderheide, Graham Nichol, Thomas D. Rea, Siobhan P. Brown, Brian G. Leroux, Paul E. Pepe, Peter J. Kudenchuk, Jim Christenson, Mohamud R. Daya, Paul Dorian, Clifton W. Callaway, Ahamed H. Idris, Douglas Andrusiek, Shannon W. Stephens, David Hostler, Daniel P. Davis, James V. Dunford, Ronald G. Pirrallo, Ian G. Stiell, Catherine M. Clement & 7 others Alan Craig, Lois Van Ottingham, Terri A. Schmidt, Henry E. Wang, Myron L. Weisfeldt, Joseph P. Ornato, George Sopko

Research output: Contribution to journalArticle

145 Citations (Scopus)

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-of-hospital 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.)

Original languageEnglish (US)
Pages (from-to)798-806
Number of pages9
JournalNew England Journal of Medicine
Volume365
Issue number9
DOIs
StatePublished - Sep 1 2011

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Out-of-Hospital Cardiac Arrest
Electric Impedance
Equipment and Supplies
Cardiopulmonary Resuscitation
Survival
National Heart, Lung, and Blood Institute (U.S.)
Heart Arrest
Cardiac Output
Canada
Hospital Emergency Service
Therapeutics
Survival Rate
Research Personnel
Confidence Intervals
Pressure

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Aufderheide, T. P., Nichol, G., Rea, T. D., Brown, S. P., Leroux, B. G., Pepe, P. E., ... Sopko, G. (2011). A Trial of an Impedance Threshold Device in Out-of-Hospital Cardiac Arrest. New England Journal of Medicine, 365(9), 798-806. https://doi.org/10.1056/NEJMoa1010821

A Trial of an Impedance Threshold Device in Out-of-Hospital Cardiac Arrest. / Aufderheide, Tom P.; Nichol, Graham; Rea, Thomas D.; Brown, Siobhan P.; Leroux, Brian G.; Pepe, Paul E.; Kudenchuk, Peter J.; Christenson, Jim; Daya, Mohamud R.; Dorian, Paul; Callaway, Clifton W.; Idris, Ahamed H.; Andrusiek, Douglas; Stephens, Shannon W.; Hostler, David; Davis, Daniel P.; Dunford, James V.; Pirrallo, Ronald G.; Stiell, Ian G.; Clement, Catherine M.; Craig, Alan; Van Ottingham, Lois; Schmidt, Terri A.; Wang, Henry E.; Weisfeldt, Myron L.; Ornato, Joseph P.; Sopko, George.

In: New England Journal of Medicine, Vol. 365, No. 9, 01.09.2011, p. 798-806.

Research output: Contribution to journalArticle

Aufderheide, TP, Nichol, G, Rea, TD, Brown, SP, Leroux, BG, Pepe, PE, Kudenchuk, PJ, Christenson, J, Daya, MR, Dorian, P, Callaway, CW, Idris, AH, Andrusiek, D, Stephens, SW, Hostler, D, Davis, DP, Dunford, JV, Pirrallo, RG, Stiell, IG, Clement, CM, Craig, A, Van Ottingham, L, Schmidt, TA, Wang, HE, Weisfeldt, ML, Ornato, JP & Sopko, G 2011, 'A Trial of an Impedance Threshold Device in Out-of-Hospital Cardiac Arrest', New England Journal of Medicine, vol. 365, no. 9, pp. 798-806. https://doi.org/10.1056/NEJMoa1010821
Aufderheide, Tom P. ; Nichol, Graham ; Rea, Thomas D. ; Brown, Siobhan P. ; Leroux, Brian G. ; Pepe, Paul E. ; Kudenchuk, Peter J. ; Christenson, Jim ; Daya, Mohamud R. ; Dorian, Paul ; Callaway, Clifton W. ; Idris, Ahamed H. ; Andrusiek, Douglas ; Stephens, Shannon W. ; Hostler, David ; Davis, Daniel P. ; Dunford, James V. ; Pirrallo, Ronald G. ; Stiell, Ian G. ; Clement, Catherine M. ; Craig, Alan ; Van Ottingham, Lois ; Schmidt, Terri A. ; Wang, Henry E. ; Weisfeldt, Myron L. ; Ornato, Joseph P. ; Sopko, George. / A Trial of an Impedance Threshold Device in Out-of-Hospital Cardiac Arrest. In: New England Journal of Medicine. 2011 ; Vol. 365, No. 9. pp. 798-806.
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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-of-hospital 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.)",
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T1 - A Trial of an Impedance Threshold Device in Out-of-Hospital Cardiac Arrest

AU - Aufderheide, Tom P.

AU - Nichol, Graham

AU - Rea, Thomas D.

AU - Brown, Siobhan P.

AU - Leroux, Brian G.

AU - Pepe, Paul E.

AU - Kudenchuk, Peter J.

AU - Christenson, Jim

AU - Daya, Mohamud R.

AU - Dorian, Paul

AU - Callaway, Clifton W.

AU - Idris, Ahamed H.

AU - Andrusiek, Douglas

AU - Stephens, Shannon W.

AU - Hostler, David

AU - Davis, Daniel P.

AU - Dunford, James V.

AU - Pirrallo, Ronald G.

AU - Stiell, Ian G.

AU - Clement, Catherine M.

AU - Craig, Alan

AU - Van Ottingham, Lois

AU - Schmidt, Terri A.

AU - Wang, Henry E.

AU - Weisfeldt, Myron L.

AU - Ornato, Joseph P.

AU - Sopko, George

PY - 2011/9/1

Y1 - 2011/9/1

N2 - 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-of-hospital 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.)

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