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.

Primary outcome: 6 months survival with good neurological outcome (Cerebral Performance Category 1-2). Secondary outcomes will include 30 day neurological and cardiac recovery.

Discussion: 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.

Figure 1

Prague OHCA study outline. Abbreviations: ACLS: advanced cardiac life support; AG: angiography; ASAP: as soon as possible; BLS: basic life support; CPC: cerebral performance category; CPR: cardiopulmonary resuscitation; CT: computed tomography; ECLS: extracorporeal life support; EMS: emergency medical service; ERC: European Resuscitation Council; ICU: intensive care unit; I/E: inclusion/exclusion; NIRS: near infrared spectroscopy; OHCA: out of hospital cardiac arrest; ROSC: return of spontaneous circulation; STEMI: ST elevation acute myocardial infarction; TTE: transthoracic echocardiography.

Figure 2

Graphical delineation for scenario 1, estimated 10% increase of primary outcome in hyperinvasive (20%) vs. standard (10%) groups.

Figure 3

Graphical delineation for scenario 2, estimated 15% increase of primary outcome in hyperinvasive (25%) vs. standard (10%) groups.

Figure 4

Graphical delineation for scenario 3, estimated 20% increase of primary outcome in hyperinvasive (30%) vs. standard (10%) groups.