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| ID | Type | Description | Link |
|---|---|---|---|
| CNIL 908.476 |
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Angioscanners in excess of the SNA group because of use of thiopental
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SNA group | This group will have a real-time analysis of autonomic nervous system activity during its intensive care hospitalisation | ||
| Clinical group | This group will have a conventional clinical analysis during its intensive care hospitalisation |
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| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| the number of patients and the number of organs removed | At the end of the study |
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Inclusion Criteria:
Exclusion Criteria:
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subjects with severe cerebral lesions admitted in intensive care units
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| Name | Affiliation | Role |
|---|---|---|
| David CHARIER, MD | CHU de Saint-Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Dijon | Dijon | 21000 | France | |||
| CH Roanne |
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| Roanne |
| 42700 |
| France |
| CHU de Saint-Etienne | Saint-Etienne | 42055 | France |
| ID | Term |
|---|---|
| D020202 | Cerebral Hemorrhage, Traumatic |
| D020201 | Brain Hemorrhage, Traumatic |
| D000070642 | Brain Injuries, Traumatic |
| D001926 | Brain Death |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D002543 | Cerebral Hemorrhage |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D020198 | Intracranial Hemorrhage, Traumatic |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D014947 | Wounds and Injuries |
| D003128 | Coma |
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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