Acquisition and Analysis of Medullary Trauma Patients Signs, With an Expert Model
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Assessment of change of ASIA impairment scale (American Spinal Cord Injury Association)
研究概览
简要总结
The aim of this study was to analyze using an artificial intelligence engine (IA) the influence of the pathophysiological environment (set parametric monitoring data, imaging, biology etc.) of acute spinal cord trauma on spinal pain. This project seeks to establish the principles of a new approach for studying spinal cord injury patients. It does not meet the usual criteria of clinical trials in so far as it does not test on patients the effect of a therapeutic
详细描述
Objectives
The objectives are multiple:
-
Analyze clinical situation in the pathophysiology of spinal pain.
-
somatosensory evoked potentials analysis (PES) and motors (PEM) on injuries of the spinal cord in the acute phase.
-
Increasing the mass of data integrated from current standards (volume). The reason is not only an imperative of statistical power as in a conventional test but the probability of specific events characterize this type of pathology and the consequences of their management (monitoring and therapeutic).
-
Identify new predictive parameters and monitoring of spinal pain.
-
Design the tools of computer collection, successful storage formats, adaptations of collection tools: This is validation of the technical solution (i.e. IA).
Expected results
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Patient with acute spinal cord injury between the cord opposite the vertebra C2 and marrow compared to the T12 vertebra.
- •neurological lesion classified A, B, C or D according to Frankel classification at the initial examination (Annex 1).
- •Patient able to give informed consent
排除标准
- •There are no exclusion criteria. All patients meeting the inclusion criteria are includable. However, it differs remarkable different situations:
- •The clinical neurological assessment of patients may be difficult depending on the context: intubated patients admitted - ventilated multiple trauma.
- •Neurological assessment via evoked potentials may be difficult depending on the environment for patient care: need for multiple investigations, resuscitation. Evoked potentials will be installed only after agreement of the healthcare team once the patient is stabilized.
- •The patient can refuse to submit to one additional exam is not part of the standard care (i.e. PES / PEM); it will be offered to participate in the study without the completion of this review. It will be in this case a simple use of clinical and laboratory data collected retrospectively anonymized so for scientific purposes.
结局指标
主要结局
Assessment of change of ASIA impairment scale (American Spinal Cord Injury Association)
时间窗: Day1, 6 months and 1 year
ASIA impairment scale allows to classify the spinal cord injury according to its level of neurological damage. It is conventionally represented by the most caudal segment having a normal function. It allows to appreciate the completeness or incompleteness of the attack. It allows a classification highlighting the severity of the attack by using a five-letter ASIA anomaly scale from A to E.
次要结局
- Assessment of change of Motor Evoked Potentials (PEM)(Day1, 6 months)
- Assessment of change of Somatosensory Evoked Potentials (SEPs)(Day1, 6 months)