Artificial Intelligence Analysis of Initial Scan Evolution of Traumatic Brain Injured Patient to Predict Neurological Outcome: Pilot Translational an Exploratory Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Clinical evolution during first 7 days in ICU with therapeutic intensity level (TILsum)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Clinical evolution during first 7 days in ICU with therapeutic intensity level (TILsum)
时间窗: 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.
次要结局
- Morbidity (consequences of the trauma) according to scan profiles(6 months after TBI)
- Comparison and Description of correlation between early scan profiles evolution signature by AI and to clinical evolution (with TILSum)(7 days after TBI)
- Mortality according to scan profiles(28 days after TBI and 6 month after TBI)
- Neurological Pupil Index(1 day after TBI)