RESUMEN
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.
Asunto(s)
Reanimación Cardiopulmonar/instrumentación , Servicios Médicos de Urgencia/organización & administración , Paro Cardíaco/terapia , Hipertermia Inducida , HumanosRESUMEN
INTRODUCTION: Circadian variation of in-hospital acute cardiogenic pulmonary oedema (CPE) with the highest occurrence in the early morning has been reported repeatedly. However, no study evaluating circadian variation of CPE in the field has been published. Therefore, we decided to evaluate the circadian variation of CPE in the Central Bohemian Region of the Czech Republic in the patients treated by regional emergency medical service (EMS) and analyse its association with baseline blood pressure in the field. METHODS: We extracted all dispatches to CPE cases from EMS database for the period from 1.11.2008 to 30.6.2014 and analysed for circadian variation. We identified the patients presenting with CPE coupled with arterial hypertension (systolic blood pressure >140mmHg) and hypotension (systolic blood pressure <90mmHg) and compared the subgroups (both subgroups include 2744 subjects). RESULTS: In 4747 episodes of CPE, maximal occurrence was detected in the ninth hour in the morning, representing 7.7% of all CPE episodes (p<0.05). While CPE with hypertension (2463 subjects) reached maximal occurrence also in the ninth hour (7.4% of all cases, p<0.05), CPE with hypotension (281 patients) was most frequent in the fourteenth hour (8.6% of all cases, p<0.05). CONCLUSION: The highest occurrence of CPE was observed in the ninth hour in the morning in our study. Moreover, differences in circadian variation between CPE with hypertension and hypotension were identified. Knowledge of these patterns may have an impact on the logistic of prehospital emergency care and on preventive measures in the patients who have previously undergone CPE.