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

被引:180
作者
Aufderheide, Tom P. [1 ]
Nichol, Graham [2 ,5 ]
Rea, Thomas D. [3 ]
Brown, Siobhan P. [5 ]
Leroux, Brian G. [5 ]
Pepe, Paul E. [6 ]
Kudenchuk, Peter J. [4 ]
Christenson, Jim [7 ,9 ]
Daya, Mohamud R. [10 ]
Dorian, Paul [11 ]
Callaway, Clifton W. [13 ]
Idris, Ahamed H. [6 ]
Andrusiek, Douglas [8 ,9 ]
Stephens, Shannon W.
Hostler, David [13 ]
Davis, Daniel P. [14 ]
Dunford, James V. [14 ]
Pirrallo, Ronald G. [1 ]
Stiell, Ian G. [15 ,16 ]
Clement, Catherine M. [15 ,16 ]
Craig, Alan [12 ]
Van Ottingham, Lois [5 ]
Schmidt, Terri A. [10 ]
Wang, Henry E.
Weisfeldt, Myron L. [17 ]
Ornato, Joseph P. [19 ]
Sopko, George [18 ]
机构
[1] Med Coll Wisconsin, Dept Emergency Med, 9200 W Wisconsin Ave,Pavil 1P, Milwaukee, WI 53226 USA
[2] Univ Washington, Harborview Ctr Prehosp Emergency Care, Seattle, WA 98195 USA
[3] Univ Washington, Div Gen Med, Seattle, WA 98195 USA
[4] Univ Washington, Div Cardiol, Dept Med, Seattle, WA 98195 USA
[5] Univ Washington, Dept Biostat, Clin Trials Ctr, Seattle, WA 98195 USA
[6] Univ Texas SW Med Ctr Dallas, Dept Surg Emergency Med, Dallas, TX 75390 USA
[7] Univ British Columbia, Dept Emergency Med, Vancouver, BC V5Z 1M9, Canada
[8] Univ British Columbia, Sch Populat & Publ Hlth, Vancouver, BC V5Z 1M9, Canada
[9] British Columbia Emergency & Hlth Serv Commiss, Vancouver, BC, Canada
[10] Oregon Hlth & Sci Univ, Dept Emergency Med, Ctr Policy & Res Emergency Med, Portland, OR 97201 USA
[11] Univ Toronto, Dept Med, Toronto, ON, Canada
[12] Toronto Emergency Med Serv, Toronto, ON, Canada
[13] Univ Pittsburgh, Dept Emergency Med, Pittsburgh, PA USA
[14] Univ Calif San Diego, Dept Emergency Med, San Diego, CA 92103 USA
[15] Univ Ottawa, Dept Emergency Med, Ottawa, ON, Canada
[16] Univ Ottawa, Ottawa Hosp Res Inst, Ottawa, ON, Canada
[17] Johns Hopkins Med Inst, Dept Med, Baltimore, MD 21205 USA
[18] NHLBI, NIH, Bethesda, MD 20892 USA
[19] Virginia Commonwealth Univ, Dept Emergency Med, Richmond, VA USA
基金
加拿大健康研究院;
关键词
CARDIOPULMONARY-RESUSCITATION; PORCINE MODEL; HEMODYNAMICS; SURVIVAL;
D O I
10.1056/NEJMoa1010821
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.)
引用
收藏
页码:798 / 806
页数:9
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