Interest of Real Time Measurement of Autonomous Nervous System for the Detection of Brain Death

Study Overview
=================
Brief Summary
-----------------
Context: A major lack of organ donors is a serious public health problem. It determines a prolonged delay before a transplant can be performed and thus a significant number of deaths of patients waiting for transplantation. The aim of this project is to reduce the delay of the diagnosis of brain death, and also to improve its diagnosis in the Intensive Care Unit. The diagnosis of brain death is strictly defined by the law and relies either on two consecutive flat electroencephalograms recorded at an interval of four hours, or on the lack of cerebral circulation during a brain angiography performed after suspecting brain death on the clinical exam. However, in usual practice, it is difficult to have all the needed clinical arguments, and their interpretation can be difficult in the pathological context. This may participate in the delay and the lack of patients potentially donors. Pre-study: In a pilot study, fifty subjects with severe cerebral lesions, had a continuous ECG recording. The investigators could find that a decrease in autonomic nervous system activity, as measured through the ECG, was correlated to the transition to brain death assessed by cerebral angiography. The loss of cardiac variability was always observed between two cerebral angiographies, one before and the second after brain death. This study allowed the investigators to calculate the threshold values of sympathetic and parasympathetic activities to confirm brain death.

Detailed Description
-----------------
Aim: The aim of this second study is to validate prospectively the interest of the analysis in real-time of autonomic nervous system activity to detect brain death. Benefits expected: Increase the number of organ donors and the number of organs removal available for transplantation.

Official Title
-----------------
Interest of Real Time Measurement of Autonomous Nervous System for the Detection of Brain Death: the MEANS Study

Conditions
-----------------
Cerebral Hematoma, Traumatic, Intracerebral Hemorrhage, Traumatic, Traumatic Brain Hemorrhage, Traumatic Brain Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: severe cerebral lesions admitted in intensive care units Exclusion Criteria: neoplastic pathology prior myocardiac infarction hearth failure atrial fibrillation insulin-treated diabetes mellitus cardiac pacemaker

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SNA group<br>This group will have a real-time analysis of autonomic nervous system activity during its intensive care hospitalisation | |
| Clinical group<br>This group will have a conventional clinical analysis during its intensive care hospitalisation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the delay between the falling down of autonomic nervous system activity and the confirmation of the brain death using cerebral angiography |  | At confirmation of the brain death | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of patients and the number of organs removed |  | At the end of the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
autonomous nervous system, brain death, organs transplantation