Pre-Hospital Cooling in Cardiac Arrest Patients

Emergency Medical Service of the Central Bohemian Region, Czech Republic40 enrolled

Overview

Type of study: Pilot prospective nonrandomized feasibility clinical study. Aim of the study: To assess the feasibility of pre-hospital therapeutic mild hypothermia in patients successfully resuscitated from out-of-hospital cardiac arrest in the setting of prehospital and hospital care in Czech republic. Evaluated hypothesis: Pre-hospital initiation of therapeutic mild hypothermia by rapid administration of intravenous bolus of cold crystalloids is simple, safe, effective and is a feasible procedure to significantly decrease body core temperature during patient's transport to the hospital in Czech republic. The study is observational and does not evaluate any new drug, therapeutic procedure or diagnostic procedure. It is evaluating a known therapeutic procedure, therapeutic mild hypothermia, induced by known technique, cold crystalloid infusion, widely accepted in hospital-related postresuscitative care. However, even its prehospital usage has been published.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cardiac Arrest

Interventions

Induction of therapeutic mild hypothermiaPROCEDURE

Rapid administration of 4°C cold normal saline to the peripheral vein, dose 5 - 30 ml/kg, to decrease body core temperature below 34°C

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * patients resuscitated from out-of-hospital cardiac arrest * remaining comatose and requiring mechanical ventilation Exclusion Criteria: * cardiac arrest of traumatic etiology * patient conscious after short cardiopulmonary resuscitation * coma of other origin than cardiac arrest (e.g., epileptic paroxysm, intoxication etc.) * severe acute heart failure * accidental hypothermia below 30°C * bradycardia requiring transcutaneous cardiac pacing * status Do Not Resuscitate or Do Not Intubate * severe circulatory shock * severe life threatening cardiac arrhythmias * severe and life threatening bleeding * severe sepsis * any common opinion of intervening team of unfitness of induction of therapeutic mild hypothermia

Locations (2)

Emergency Medical Service of the Central Bohemian Region

Beroun, Central Bohemia, Czechia

RECRUITING

Hradec Kralove Region Emergency Medical Services, Czech republic

Hradec Králové, Region of Hradec Kralove, Czechia

RECRUITING

Outcomes

Primary Outcomes

Effectivity measure - reached cooling rate calculated in °C/30 min

Time frame: Assessed during prehospital phase

Secondary Outcomes

Appearance of adverse events and complications during prehospital induction of therapeutic mild hypothermia

Time frame: Assessed during prehospital phase

Achievement of favourable neurological outcome at the hospital discharge

Time frame: Assessed during prehospital and in-hospital phase

Overall prehospital and in-hospital mortality