Abstract
BackgroundTherapeutic hypothermia (TH, 32-34°C) has been shown to improve neurological outcome in comatose survivors of out-of-hospital cardiac arrest (OHCA) with ventricular tachycardia or fibrillation. Earlier initiation of TH may increase the beneficial effects. Experimental studies have suggested that starting TH during cardiopulmonary resuscitation (CPR) may further enhance its neuroprotective effects. The aim of this study was to evaluate whether intra-arrest TH (IATH), initiated in the field with trans nasal evaporative cooling (TNEC), would provide outcome benefits when compared to standard of care in patients being resuscitated from OHCA.Methods/designWe describe the methodology of a multi-centre, randomized, controlled trial comparing IATH delivered through TNEC device (Rhinochill, Benechill Inc., San Diego, CA, USA) during CPR to standard treatment, including TH initiated after hospital admission. The primary outcome is neurological intact survival defined as cerebral performance category 1–2 at 90 days among those patients who are admitted to the hospital. Secondary outcomes include survival at 90 days, proportion of patients achieving a return to spontaneous circulation (ROSC), the proportion of patients admitted alive to the hospital and the proportion of patients achieving target temperature (<34°C) within the first 4 hours since CA.DiscussionThis ongoing trial will assess the impact of IATH with TNEC, which may be able to rapidly induce brain cooling and have fewer side effects than other methods, such as cold fluid infusion. If this intervention is found to improve neurological outcome, its early use in the pre-hospital setting will be considered as an early neuro-protective strategy in OHCA.Trial registrationNCT01400373.
Highlights
Therapeutic hypothermia (TH, 32-34°C) has been shown to improve neurological outcome in comatose survivors of out-of-hospital cardiac arrest (OHCA) with ventricular tachycardia or fibrillation
If this intervention is found to improve neurological outcome, its early use in the pre-hospital setting will be considered as an early neuro-protective strategy in OHCA
Despite decades of efforts to promote cardiopulmonary resuscitation (CPR) education and the introduction of automated external defibrillators, less than 50% of cardiac arrest (CA) victims achieve a return of spontaneous circulation (ROSC) and this percentage drops to 20% or less for those patients that live in rural areas or do not have an initial rhythm that can be
Summary
Therapeutic hypothermia (TH, 32-34°C) has been shown to improve neurological outcome in comatose survivors of out-of-hospital cardiac arrest (OHCA) with ventricular tachycardia or fibrillation. In 2002, two randomized clinical trials demonstrated the benefit of therapeutic hypothermia (TH) on neurologically intact survival in patients who were cooled inhospital for 12 to 24 hours to 32-34°C within few hours from ROSC following an out-of-hospital cardiac arrest (OHCA) with ventricular fibrillation (VF) or ventricular tachycardia (VT) as first rhythm [9,10]. Based on these studies, the International Liaison Committee on Resuscitation have recommended the use of TH as a routine treatment of OHCA patients with VF/VT as first rhythm during post-resuscitation care. Rapid cooling decreased core temperature of patients at hospital arrival but did not improve outcome at hospital discharge compared with cooling commenced in the hospital [12]
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