title: Design of the PRINCESS trial: pre-hospital resuscitation intra-nasal cooling effectiveness survival study (PRINCESS).
abstract: BACKGROUND
  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. 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
  We 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.
  
  
  CONCLUSIONS
  This 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.
  
  
  BACKGROUND
  NCT01400373.
authors.affiliation: Department of Intensive Care, Hopital Erasme, Université Libre de Bruxelles (ULB), Route de Lennik, 808, Bruxelles 1070, Belgium. ftaccone@ulb.ac.be.
authors.forename: Per
authors.initials: P
authors.lastname: Nordberg
authors.forename: Fabio Silvio
authors.initials: FS
authors.lastname: Taccone
authors.forename: Maaret
authors.initials: M
authors.lastname: Castren
authors.forename: Anatolij
authors.initials: A
authors.lastname: Truhlár
authors.forename: Didier
authors.initials: D
authors.lastname: Desruelles
authors.forename: Sune
authors.initials: S
authors.lastname: Forsberg
authors.forename: Jacob
authors.initials: J
authors.lastname: Hollenberg
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Vincent
authors.forename: Leif
authors.initials: L
authors.lastname: Svensoon
mesh_terms: D000281:Administration, Intranasal / Q000295:instrumentation*; D001530:Belgium; D018153:Czech Republic; D004632:Emergency Medical Services / Q000379:methods*; D005466:Fluorocarbons / Q000008:administration & dosage; D006801:Humans; D007036:Hypothermia, Induced / Q000295:instrumentation / Q000379:methods*; D018696:Neuroprotective Agents / Q000008:administration & dosage; D058687:Out-of-Hospital Cardiac Arrest / Q000628:therapy*; D012107:Research Design; D016019:Survival Analysis; D013548:Sweden; D016896:Treatment Outcome
chemical_list: D005466:Fluorocarbons; D018696:Neuroprotective Agents; C078626:perflexane