Cardiac ARrest : Brain OXymetry Depending on HYpothermia Depth

Study Overview
=================
Brief Summary
-----------------
Cardiac arrest is a major public health problem, with 700 000 cases per year , and a survival ranging from 4 to 33%. The post- anoxic encephalopathy remains the most serious complication with only a third of survivors . It is due to a series of phenomena involving microcirculation disorders . Cerebral oximetry is a new technique to evaluate the microcirculatory status . To this day it is used in cardiovascular surgery at risk of cerebral hypoperfusion where desaturation of cerebral oximetry is synonymous with ischemia and microcirculatory disorders. Therapeutic hypothermia is the only treatment improves the outcome of patients after extra- hospital cardiac arrest resuscitation . Its mechanisms of action seem to change all the phenomena responsible for microcirculatory reperfusion disorders . Currently it is recommended to practice hypothermia between 32 and 34 ° C. However, a recent study suggests a superiority of hypothermia at 32 ° C rather than 34 ° C. The hypothesis of this study is that cerebral oximetry value will be different in patients subjected to two different levels of therapeutic hypothermia in the aftermath of an extra- hospital cardiac arrest. These data allow a better understanding of the mechanisms underlying the benefit of this technique.

Official Title
-----------------
Evaluation de l'oxymétrie cérébrale à Deux Niveaux d'Hypothermie thérapeutique après arrêt Cardiaque Extra-hospitalier

Conditions
-----------------
Cardiac Arrest

Intervention / Treatment
-----------------
* Procedure: therapeutic hypothermia at 32 ° C
* Procedure: therapeutic hypothermia at 34 ° C


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient presented with an extra-hospital cardiac arrest resuscitation and to benefit from therapeutic hypothermia using a servo system to its temperature (CoolGard 3000 ® system) Age> 18 years and <80 years Exclusion Criteria: Major Patient protected by law Private person administrative or judicial freedom Neurological or traumatic cause of cardiac arrest Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 34°C<br>therapeutic hypothermia at 34 ° C | Procedure: therapeutic hypothermia at 34 ° C<br> <br> |
| Experimental: 32°C<br>therapeutic hypothermia at 32 ° C | Procedure: therapeutic hypothermia at 32 ° C<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mesure of cerebral oximetry | During the first 48 hours of hospitalization, we will collect the cerebral oximetry values in the two cerebral hemispheres. | 8 times during the first 48 hours of hospitalization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The cerebral oximetry values (average of the two hemispheres) will be compared between patients with good and poor neurological outcome. | The cerebral oximetry values (average of the two hemispheres) will be compared between patients with good and poor neurological outcome. | 8 times during the first 48 hours of hospitalization | 
| For each level of therapeutic hypothermia the cerebral oximetry values will be compared between patients with good and poor becoming | For each level of therapeutic hypothermia (32 or 34 ° C), the cerebral oximetry values (average of the two hemispheres) will be compared between patients with good and poor becoming according to the CPC score (CPC = 1 become good score - 2 and bad become CPC = 3-5). | baseline, when target temperature is reached, 6 hours, 12 hours, 18 hours, 24 hours, when 37°C is reached | 
| Outcome of patients | The outcome of patients (score 1-2 vs. CPC. 3-5 CPC) will be compared with the level of hypothermia (32 or 34 ° C) | 6 months after hospitalization | 
| Mesure of lactate | Lactate will be compared between patients with good (CPC 1-2) and poor (CPC 3-5) become throughout the study population | 4 times during the first 48 hours of hospitalization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac arrest, Oxymetry, Hypothermia