Artificial Intelligence Analysis of Initial Scan Evolution of Traumatic Brain Injured Patient to Predict Neurological Outcome

Study Overview
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Brief Summary
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We assume that an early iterative automatic CT scan analysis (D0, D1 and D3) by different AI approaches will allow an early differentiation of the tissues evolution after TBI. Our objective is to couple theses scan profiles to a neurological evolution, measured by therapeutic intensity.

Detailed Description
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Traumatic brain injury is a common and serious pathology, responsible of an important morbi-mortality. The TBI can be consider as a complex set of nosological entities of different evolution with difficult early identification whereas the main issue of this pathology depends on prevention and management of the lesions caused by the initial cerebral aggression. Different evolutionary profiles seems to exist and sometimes coexists: edema evolution, hemorrhagic transformation and/or cerebrospinal fluid (CSF) resorption issues with hydrocephalus apparition. Currently, there is no Imaging methods that can be used in every day clinical management that allows a visualization, quantification and prediction of these different lesional evolutions CT scan is the reference imaging method for TBI patient monitoring. It allows a lesion description, a therapeutic adaptation and an evaluation of the prognostic. Even if it is used as a routine examination, the analysis of cerebral scanners remains manual and a non-quantitative one, which make a little informative analysis as far as lesions evolution is concerned. Recently it has been established the automatic MRI analysis with AI approach allows: - To show aspects of images that can't be seen to the naked eye - To automatically segment and quantify the different tissues (edema, hemorrhage...). First tests on this kind of analysis on CT scans shows that this technology can be transferred from MRI to CT scans and more importantly it brings out new quantitative informations on cerebral lesions evolution.

Official Title
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Artificial Intelligence Analysis of Initial Scan Evolution of Traumatic Brain Injured Patient to Predict Neurological Outcome: Pilot Translational an Exploratory Study

Conditions
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Trauma, Brain

Intervention / Treatment
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* Radiation: CT scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > or = 18 years old Closed TBI Primary admission in Grenoble University Hospital Initial CT scan with visible cerebral lesion rated at least 3 on abbreviated injury score (AIS) In ICU for an expected length of 48 hours Social security system affiliation Exclusion Criteria: Life expectation <48 hours In ICU for more than 24h Transferred from another hospital Patients corresponding to articles L1121-5, L1121-6, L1121-7, L1121-8 (under legal protection) of French Public Health Code Patient in exclusion time of another study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT scan<br>During this study each patient will have 3 CT scans : D0, D1 and D3. A daily follow up during first seven days in ICU, then a follow up at D28 if still in hospital, and a phone call at M6 for neurological outcome | Radiation: CT scan<br>* 3 ct scans : D0, D1 and D3<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical evolution during first 7 days in ICU with therapeutic intensity level (TILsum) | Composite criteria : Head position, depth, sort and objective of sedation, presence or absence of a CSF draining system, management of ventilation, presence or absence of a hyperosmolar therapy, management of body temperature, surgical intervention for intracranial hypertension. | 7 days after TBI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality according to scan profiles |  | 28 days after TBI and 6 month after TBI | 
| Morbidity (consequences of the trauma) according to scan profiles | Lenght of stay in ICU with more than 20 mmHg of intracranial pressure with no stimulation | 28 days after TBI | 
| Morbidity (consequences of the trauma) according to scan profiles | length of stay in ICU with a therapeutic intensity level > or = 8, | 28 days after TBI | 
| Morbidity (consequences of the trauma) according to scan profiles | Hospital stay length | 28 days after TBI | 
| Morbidity (consequences of the trauma) according to scan profiles | ICU stay length days with mechanical ventilation | 28 days after TBI | 
| Morbidity (consequences of the trauma) according to scan profiles | Glasgow Outcome Scale (GOSe) | 6 months after TBI | 
| Comparison and Description of correlation between early scan profiles evolution signature by AI and to clinical evolution (with TILSum) | Analysis of main outcome (TIL sum after 7 days in ICU maximum) according to a kinetic scan evolution between D0, D1 and D3 | 7 days after TBI | 
| Neurological Pupil Index | Measure of neurological pupilla index within 1h after admission and at D1 | 1 day after TBI |