Hyperinvasive approach to out-of hospital cardiac arrest using mechanical chest compression device, prehospital intraarr
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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” Jan Belohlavek1*, Karel Kucera2, Jiri Jarkovsky3, Ondrej Franek2, Milana Pokorna2, Jiri Danda2, Roman Skripsky2, Vit Kandrnal3, Martin Balik4, Jan Kunstyr4, Jan Horak1, Ondrej Smid1, Jaroslav Valasek2, Vratislav Mrazek1, Zdenek Schwarz2 and Ales Linhart1
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. Primary outcome: 6 months survival with good neurological outcome (Cerebral Performance Category 1–2). Secondary outcomes will include 30 day neurological and cardiac recovery. (Continued on next page)
* Correspondence: [email protected] 1 2nd Department of Medicine - Department of Cardiovascular Medicine, 1st Faculty of Medicine, Charles University in Prague and General University Hospital in Prague, U Nemocnice 2, Prague 2 128 00, Czech Republic Full list of author information is available at the end of the article © 2012 Belohlavek et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Belohlavek et al. Journal of Translational Medicine 2012, 10:163
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