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

Not Applicable
Conditions
Trauma, Brain
Registration Number
NCT04058379
Lead Sponsor
University Hospital, Grenoble
Brief Summary

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

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:

1. - To show aspects of images that can't be seen to the naked eye

2. - 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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
30
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Clinical evolution during first 7 days in ICU with therapeutic intensity level (TILsum)7 days after TBI

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.

Secondary Outcome Measures
NameTimeMethod
Morbidity (consequences of the trauma) according to scan profiles6 months after TBI

Glasgow Outcome Scale (GOSe)

Comparison and Description of correlation between early scan profiles evolution signature by AI and to clinical evolution (with TILSum)7 days after TBI

Analysis of main outcome (TIL sum after 7 days in ICU maximum) according to a kinetic scan evolution between D0, D1 and D3

Mortality according to scan profiles28 days after TBI and 6 month after TBI
Neurological Pupil Index1 day after TBI

Measure of neurological pupilla index within 1h after admission and at D1

Trial Locations

Locations (1)

University Hospital Grenoble

🇫🇷

Grenoble, France

University Hospital Grenoble
🇫🇷Grenoble, France
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