Evaluation de l'oxymétrie cérébrale à Deux Niveaux d'Hypothermie thérapeutique après arrêt Cardiaque Extra-hospitalier
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 44
- Locations
- 2
- Primary Endpoint
- Mesure of cerebral oximetry
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
34°C
therapeutic hypothermia at 34 ° C
Intervention: therapeutic hypothermia at 34 ° C (Procedure)
32°C
therapeutic hypothermia at 32 ° C
Intervention: therapeutic hypothermia at 32 ° C (Procedure)
Outcomes
Primary Outcomes
Mesure of cerebral oximetry
Time Frame: 8 times during the first 48 hours of hospitalization
During the first 48 hours of hospitalization, we will collect the cerebral oximetry values in the two cerebral hemispheres.
Secondary Outcomes
- Outcome of patients(6 months after hospitalization)
- Mesure of lactate(4 times during the first 48 hours of hospitalization)
- 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(baseline, when target temperature is reached, 6 hours, 12 hours, 18 hours, 24 hours, when 37°C is reached)