Pre-Hospital Cooling in Cardiac Arrest Patients (PRE-COOL)

Emergency Medical Service of the Central Bohemian Region, Czech Republic

Status

Unknown

Conditions

Cardiac Arrest

Treatments

Procedure: Induction of therapeutic mild hypothermia

Study type

Observational

Funder types

Other

Identifiers

NCT00915421

SCK-KVK-001

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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