Traumatic Brain Injury Clinical Trial
Official title:
Interest of Real Time Measurement of Autonomous Nervous System for the Detection of Brain Death: the MEANS Study
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.
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.
;
Observational Model: Case-Only, Time Perspective: Prospective
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