A randomized trial of expedited intra-arrest transfer versus more extended on-scene resuscitation for refractory out of hospital cardiac arrest: Rationale and design of the EVIDENCE trial

被引:5
作者
Burns, Brian [1 ,2 ]
Marschner, Ian [2 ,3 ]
Eggins, Renee [2 ,3 ]
Buscher, Hergen [4 ,5 ]
Morton, Rachael L. [2 ]
Bendall, Jason [1 ]
Keech, Anthony [2 ,6 ]
Dennis, Mark [2 ,6 ,7 ]
机构
[1] New South Wales Air Ambulance, Sydney, NSW, Australia
[2] Univ Sydney, Fac Med & Hlth, Sydney, Australia
[3] Univ Sydney, NHMRC Clin Trials Ctr, Sydney, NSW, Australia
[4] St Vincents Hosp, Sydney, Australia
[5] Univ New South Wales, Sydney, Australia
[6] Royal Prince Alfred Hosp, Sydney, Australia
[7] Missenden Rd, Darlington, NSW 2006, Australia
基金
芬兰科学院;
关键词
EXTRACORPOREAL CARDIOPULMONARY-RESUSCITATION; PERCUTANEOUS CORONARY INTERVENTION; EARLY REPERFUSION; MULTICENTER; STATEMENT; SURVIVAL; INSIGHTS; OUTCOMES; CPR;
D O I
10.1016/j.ahj.2023.10.003
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Background Refractory Out of Hospital Cardiac Arrest (r-OHCA) is common and the benefit versus harm of intra-arrest transport of patients to hospital is not clear.Objective To assess the rate of survival to hospital discharge in adult patients with r-OHCA, initial rhythm pulseless ventricular tachycardia (VT)/ventricular fibrillation (VF) or Pulseless Electrical Activity (PEA) treated with 1 of 2 locally accepted standards of care:1 expedited transport from scene; or2 ongoing advanced life support (ALS) resuscitation on-scene.Hypothesis We hypothesize that expedited transport from scene in r-OHCA improves survival with favorable neuro-logical status/outcome. Methods/Design Phase III, multi-center, partially blinded, prospective, intention-to-treat, safety and efficacy clinical trial with contemporaneous registry of patient ineligible for the clinical trial. Eligible patients for inclusion are adults with witnessed r-OHCA; estimated age 18 to 70, assumed medical cause with immediate bystander cardiopulmonary resuscitation (CPR); initial rhythm of VF/pulseless VT, or PEA; no return of spontaneous circulation following 3 shocks and/or 15 minutes of professional on-scene resuscitation; with mechanical CPR available. Two hundred patients will be randomized in a 1:1 ratio to either expedited transport from scene or ongoing ALS at the scene of cardiac arrest.Setting Two urban regions in NSW Australia.Outcomes Primar y: sur vival to hospital discharge with cerebral performance category (CPC) 1 or 2. Secondary: safety, survival, prognostic factors, use of ECMO supported CPR and functional assessment at hospital discharge and 4 weeks and 6 months, quality of life, healthcare use and cost-effectiveness.Conclusions The EVIDENCE trial will determine the potential risks and benefits of an expedited transport from scene of cardiac arrest. (Am Heart J 2024;267:22-32.)
引用
收藏
页码:22 / 32
页数:11
相关论文
共 43 条
[1]   Cost-effectiveness of extracorporeal cardiopulmonary resuscitation for adult out-of-hospital cardiac arrest: A systematic review [J].
Addison, Danielle ;
Cheng, Evan ;
Forrest, Paul ;
Livingstone, Ann ;
Morton, Rachael L. ;
Dennis, Mark .
RESUSCITATION, 2022, 178 :19-25
[2]   Standard cardiopulmonary resuscitation versus active compression-decompression cardiopulmonary resuscitation with augmentation of negative intrathoracic pressure for out-of-hospital cardiac arrest: a randomised trial [J].
Aufderheide, Tom P. ;
Frascone, Ralph J. ;
Wayne, Marvin A. ;
Mahoney, Brian D. ;
Swor, Robert A. ;
Domeier, Robert M. ;
Olinger, Michael L. ;
Holcomb, Richard G. ;
Tupper, David E. ;
Yannopoulos, Demetris ;
Lurie, Keith G. .
LANCET, 2011, 377 (9762) :301-311
[3]   The Minnesota mobile extracorporeal cardiopulmonary resuscitation consortium for treatment of out-of-hospital refractory ventricular fibrillation: Program description, performance, and outcomes [J].
Bartos, Jason A. ;
Frascone, R. J. ;
Conterato, Marc ;
Wesley, Keith ;
Lick, Charles ;
Sipprell, Kevin ;
Vuljaj, Nik ;
Burnett, Aaron ;
Peterson, Bjorn K. ;
Simpson, Nicholas ;
Ham, Kealy ;
Bruen, Charles ;
Woster, Casey ;
Haley, Kari B. ;
Moore, Joanna ;
Trigger, Brandon ;
Hodgson, Lucinda ;
Harkins, Kim ;
Kosmopoulos, Marinos ;
Aufderheide, Tom P. ;
Tolar, Jakub ;
Yannopoulos, Demetris .
ECLINICALMEDICINE, 2020, 29-30
[4]   Improved Survival With Extracorporeal Cardiopulmonary Resuscitation Despite Progressive Metabolic Derangement Associated With Prolonged Resuscitation [J].
Bartos, Jason A. ;
Grunau, Brian ;
Carlson, Claire ;
Duval, Sue ;
Ripeckyj, Adrian ;
Kalra, Rajat ;
Raveendran, Ganesh ;
John, Ranjit ;
Conterato, Marc ;
Frascone, Ralph J. ;
Trembley, Alexander ;
Aufderheide, Tom P. ;
Yannopoulos, Demetris .
CIRCULATION, 2020, 141 (11) :877-886
[5]   Intraarrest transport, extracorporeal cardiopulmonary resuscitation, and early invasive management in refractory out-of-hospital cardiac arrest: an individual patient data pooled analysis of two randomised trials [J].
Belohlavek, Jan ;
Yannopoulos, Demetris ;
Smalcova, Jana ;
Rob, Daniel ;
Bartos, Jason ;
Huptych, Michal ;
Kavalkova, Petra ;
Kalra, Rajat ;
Grunau, Brian ;
Taccone, Fabio Silvio ;
Aufderheide, Tom P. .
ECLINICALMEDICINE, 2023, 59
[6]   Effect of Intra-arrest Transport, Extracorporeal Cardiopulmonary Resuscitation, and Immediate Invasive Assessment and Treatment on Functional Neurologic Outcome in Refractory Out-of-Hospital Cardiac Arrest A Randomized Clinical Trial [J].
Belohlavek, Jan ;
Smalcova, Jana ;
Rob, Daniel ;
Franek, Ondrej ;
Smid, Ondrej ;
Pokorna, Milana ;
Horak, Jan ;
Mrazek, Vratislav ;
Kovarnik, Tomas ;
Zemanek, David ;
Kral, Ales ;
Havranek, Stepan ;
Kavalkova, Petra ;
Kompelentova, Lucie ;
Tomkova, Helena ;
Mejstrik, Alan ;
Valasek, Jaroslav ;
Peran, David ;
Pekara, Jaroslav ;
Rulisek, Jan ;
Balik, Martin ;
Huptych, Michal ;
Jarkovsky, Jiri ;
Malik, Jan ;
Valerianova, Anna ;
Mlejnsky, Frantisek ;
Kolouch, Petr ;
Havrankova, Petra ;
Romportl, Dan ;
Komarek, Arnost ;
Linhart, Ales .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2022, 327 (08) :737-747
[7]  
Benjamin EJ., 2019, CIRCULATION, V139, pe56, DOI [DOI 10.1161/CIR.0000000000000746, 10.1161/CIR.0000000000000659]
[8]   Outcomes of patients with refractory out-of-hospital cardiac arrest transported to an ECMO centre compared with transport to non-ECMO centres [J].
Bernard, Stephen A. ;
Hopkins, Sarah J. ;
Ball, Jocasta C. ;
Stub, Dion A. ;
Stephenson, Michael W. ;
Nanjayya, Vinodh B. ;
Pellegrino, Vincent A. ;
Sheldrake, Jayne ;
Richardson, Alexander C. ;
Smith, Karen L. .
CRITICAL CARE AND RESUSCITATION, 2022, 24 (01) :7-13
[9]   The epidemiology of out-of-hospital cardiac arrest in Australia and New Zealand: A binational report from the Australasian Resuscitation Outcomes Consortium (Aus-ROC) [J].
Bray, Janet ;
Howell, Stuart ;
Ball, Stephen ;
Doan, Tan ;
Bosley, Emma ;
Smith, Karen ;
Dicker, Bridget ;
Faddy, Steven ;
Thorrowgood, Melanie ;
Swain, Andy ;
Thomas, Andrew ;
Wilson, Alexander ;
Shipp, Carol ;
Walker, Tony ;
Bailey, Paul ;
Finn, Judith .
RESUSCITATION, 2022, 172 :74-83
[10]   Time of on-scene resuscitation in out of-hospital cardiac arrest patients transported without return of spontaneous circulation [J].
de Graaf, Corina ;
Beesems, Stefanie G. ;
Koster, Rudolph W. .
RESUSCITATION, 2019, 138 :235-242