title: Hyperinvasive approach to out-of hospital cardiac arrest using mechanical chest compression device, prehospital intraarrest cooling, extracorporeal life support and early invasive assessment compared to standard of care. A randomized parallel groups comparative study proposal. "Prague OHCA study".
abstract: BACKGROUND
  Out of hospital cardiac arrest (OHCA) has a poor outcome. Recent non-randomized studies of ECLS (extracorporeal life support) in OHCA suggested further prospective multicenter studies to define population that would benefit from ECLS. We aim to perform a prospective randomized study comparing prehospital intraarrest hypothermia combined with mechanical chest compression device, intrahospital ECLS and early invasive investigation and treatment in all patients with OHCA of presumed cardiac origin compared to a standard of care.
  
  
  METHODS
  This paper describes methodology and design of the proposed trial. Patients with witnessed OHCA without ROSC (return of spontaneous circulation) after a minimum of 5 minutes of ACLS (advanced cardiac life support) by emergency medical service (EMS) team and after performance of all initial procedures (defibrillation, airway management, intravenous access establishment) will be randomized to standard vs. hyperinvasive arm. In hyperinvasive arm, mechanical compression device together with intranasal evaporative cooling will be instituted and patients will be transferred directly to cardiac center under ongoing CPR (cardiopulmonary resuscitation). After admission, ECLS inclusion/exclusion criteria will be evaluated and if achieved, veno-arterial ECLS will be started. Invasive investigation and standard post resuscitation care will follow. Patients in standard arm will be managed on scene. When ROSC achieved, they will be transferred to cardiac center and further treated as per recent guidelines.
  
  
  METHODS
  6 months survival with good neurological outcome (Cerebral Performance Category 1-2). Secondary outcomes will include 30 day neurological and cardiac recovery.
  
  
  CONCLUSIONS
  Authors introduce and offer a protocol of a proposed randomized study comparing a combined "hyperinvasive approach" to a standard of care in refractory OHCA. The protocol is opened for sharing by other cardiac centers with available ECLS and cathlab teams trained to admit patients with refractory cardiac arrest under ongoing CPR. A prove of concept study will be started soon. The aim of the authors is to establish a net of centers for a multicenter trial initiation in future. ETHICS AND REGISTRATION: The protocol has been approved by an Institutional Review Board, will be supported by a research grant from Internal Grant Agency of the Ministry of Health, Czech Republic NT 13225-4/2012 and has been registered under ClinicalTrials.gov identifier: NCT01511666.
authors.affiliation: 2nd Department of Medicine, 1st Faculty of Medicine, Charles University in Prague and General University Hospital in Prague, U Nemocnice 2, Prague 2 128 00, Czech Republic. jan.belohlavek@vfn.cz
authors.forename: Jan
authors.initials: J
authors.lastname: Belohlavek
authors.forename: Karel
authors.initials: K
authors.lastname: Kucera
authors.forename: Jiri
authors.initials: J
authors.lastname: Jarkovsky
authors.forename: Ondrej
authors.initials: O
authors.lastname: Franek
authors.forename: Milana
authors.initials: M
authors.lastname: Pokorna
authors.forename: Jiri
authors.initials: J
authors.lastname: Danda
authors.forename: Roman
authors.initials: R
authors.lastname: Skripsky
authors.forename: Vit
authors.initials: V
authors.lastname: Kandrnal
authors.forename: Martin
authors.initials: M
authors.lastname: Balik
authors.forename: Jan
authors.initials: J
authors.lastname: Kunstyr
authors.forename: Jan
authors.initials: J
authors.lastname: Horak
authors.forename: Ondrej
authors.initials: O
authors.lastname: Smid
authors.forename: Jaroslav
authors.initials: J
authors.lastname: Valasek
authors.forename: Vratislav
authors.initials: V
authors.lastname: Mrazek
authors.forename: Zdenek
authors.initials: Z
authors.lastname: Schwarz
authors.forename: Ales
authors.initials: A
authors.lastname: Linhart
mesh_terms: D016887:Cardiopulmonary Resuscitation / Q000295:instrumentation*; D004632:Emergency Medical Services / Q000458:organization & administration*; D006323:Heart Arrest / Q000628:therapy*; D006801:Humans; D006979:Hyperthermia, Induced