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N Engl J Med. 2011 Sep 1;365(9):798-806. doi: 10.1056/NEJMoa1010821.

A trial of an impedance threshold device in out-of-hospital cardiac arrest.

Collaborators (419)

Kerby JD, Wang HE, Brown TB, Stephens SW, Williams CR, Caldwell S, Lai KR, Gray R, Acker JE, Minor ML, Reed J, Begue J, Gilford W, Idris AH, Fowler R, Miller R, Minei J, Pepe P, Ramsay M, Simonson R, Wigginton J, Beadle S, Climer D, Moffat M, Owens P, Gallegos D, O'Neill S, Smith R, Benitez F, Craft B, Detamble L, Deutsch S, Gillam T, Harvey T, Hewitt S, Isaacs M, Kayea T, LaChance R, Lehman T, Lemecha D, Malvik C, Mayer P, Metzger J, Miller D, Muse B, Pickard K, Ross B, Vinson C, Arze S, Black S, Bush M, Kelly R, Thornton E, Elder W, Marcucci J, Hum L, Gamber M, Aufderheide TP, Pirrallo RG, Brasel KJ, Winthrop AL, Klein JP, Brandt J, Bialkowski W, Hermanson B, McCormick K, Sandoval C, Burpee K, Price G, Morrow K, Noldin J, Kitscha DJ, Burja BJ, von Briesen C, Sparks CW, Walsh P, Chianelli J, Forster R, Milbrath M, Pukansky L, Sternig K, Chin E, Frieberg N, Krueger K, Szewczuga D, Duerr T, Funk R, Jacobsen G, Spitzer J, Demien R, Martins J, Cohn J, Spahn RR, Jankowski M, James T, Wentlandt WE Jr, Berousek D, Satula BM, Behling JB, Redman K, Hook S, Neargarder A, Singer J, Reminga T, Shepherd D, Holzhauer P, Rubin J, Skold C, Alvarez O, Harkins H, Barthell E, Haselow W, Yee A, Whitcomb J, Castro EE, Motarjeme S, Coogan P, Rader K, Glaspy J, Gerschke G, Croft H, Brin M, Wilson C, Johnson A, Kumprey W, Stiell I, Vaillancourt C, Clement C, Beaudoin T, Da Ponti MA, Cummins J, Morrow S, Tym C, Lepage G, Banek J, Dreyer J, Munkley D, Prpic J, Maloney J, Colella P, Affleck A, Waldbillig D, Bradford P, Boyle K, Luinstra-Toohey L, Trickett J, Sykes N, Graham E, Ballah K, Hedges C, MacPhee R, DeRaad B, McCleary L, Christenson J, Andrusiek D, vanHeest R, Evans D, Hameed M, Pennington S, Connolly H, Todorova D, Christenson C, Aguirre C, Bishop D, Straight R, Twaites B, Donn S, Keetley R, Schafer N, Brannan S, Moffat G, Glinsbockel C, Anderson G, Wanger K, Balfour N, Goulding J, Callaway C, Tisherman S, Rittenberger J, Hostler D, Condle J, Kampmeyer M, Markham T, Morgan M, McMichael MR, Sabol P, Sicchitano G, Shrader A, Stull G, Groft W, McCaughan R, Rohrer R, Fuchs D, Guyette F, Jenkins W, Roth R, Walker H, Campbell T, Doshi A, MacLeod B, Daya MR, Schmidt TA, Newgard CD, Hedges JR, Griffiths DE, Zive DM, Monnig AW, Yekrang A, Tomlin B, Kampp M, Cook J, Burns J, Nelson M, Nakamura Y, Jui J, Sahni R, Warden CR, Freedman S, Shertz M, Muhr MD, Stouffer JA, Cross J, Costigan J, Gorman K, Rosteck P, Verkest M, Newton C, Beeler T, Koenig K, Lee J, Barnes R, Boyce D, Allen B, Bishop TJ, Hollingsworth M, Schult E, Sullivan S, Williams R, Dehart S, Stevens M, Pizzo R, Hawks R, Glaser A, Chin J, Blount J, Zoutendijk G, Koppenhafer C, Depuy C, Hinds K, Noble T, Wittwer L, Albrich M, Carnevale T, Schlesinger P, Schmiedeskamp K, Reiter A, Arnold K, Ramey P, McDonald R, Walsh H, Davis D, Vilke G, Dunford JV, Aker DK, Barsalou T, Haynes B, Schwartz B, Mebust D, Bei R, Skeoch G, Grad M, Grover I, Glassman J, Andree SR, Morikado L, Kramer M, Calkins T, Tamsen M, Linnik W, Glasser J, Kudenchuk PJ, Rea TD, Copass M, Eisenberg MS, Olsufka M, Solberg D, Ragsdale S, Larsen J, Helbock M, Slutsky A, Morrison LJ, Dorian P, Craig A, Baker A, Hutchison J, Rotstein O, Verbeek PR, MacDonald R, Black S, Rizoli S, Cheskes S, Brooks S, Byers A, Taher A, Turgulov A, Bigham B, Cameron B, Wenkstern C, Zhan C, Foerster C, Beers C, Beecroft J, Frank J, Mercer M, Kernen M, Grife M, Qovaizi M, Van Rooyen P, DeMaio P, Chadha R, Chung S, Perreira T, Ryan W, Bradshaw D, Whiteley J, Burgess R, Waite T, Epp M, Feldman M, Olnyk R, Sage G, Moore J, Burton T, King K, Jones V, McNenly S, Benson A, Moran P, Nemeth M, Renaud R, Shield J, Silver D, Stevens J, Verbeek R, Webb K, Suthons R, Tyukodi S, Locke J, Mokedanz D, Beckett W, Cheskes S, Craig A, Redelmeier D, Hutchison J, Spence J, Kadic M, Driscoll S, Nowicky R, Hogan S, Simonini J, Burgess G, Braga D, Molyneaux LA, McLennan M, Walker J, Back A, Chen D, Kadic E, Mueller H, Tyrwhitt J, Vardy C, Renton J, McGrath-Chong M, Allan K, Bath K, Steeves L, Lewarne L, Pagulayan M, Piette M, Shahid N, Gobin R, Tessema S, Weisfeldt M, Ornato JP, Sopko G, Egan D, Lathrop D, Mascette A, Nickens PD, Wu C, Mitchell P, Hoke T, van Belle G, Emerson S, Nichol G, Leroux B, Powell J, Van Ottingham L, Sears G, Brown S, Schmicker R, Cook A, Rudser K, Ledingham RB, Bergsten-Buret B, Moore R, Gest A, Sitlani C, Koprowicz K, Thomas L, Gabriel E, Wu K, Schroeder D, Shen C, Kirdpoo W, Berhorst J, Leonen A, Wang Y, Hallstrom A.

Author information

1
Department of Emergency Medicine, Medical College of Wisconsin, Milwaukee, WI 53226, USA. taufderh@mcw.edu

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.).

PMID:
21879897
PMCID:
PMC3204381
DOI:
10.1056/NEJMoa1010821
[Indexed for MEDLINE]
Free PMC Article

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