Detection of Intracorporeal Bioresistant Nanocomposites Tracing Short- and Long-term Neurological Disorders in a Collective Fulguration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 5
- 主要终点
- Description of bioresistant nanocomposites
研究概览
简要总结
Objective: To demonstrate the presence of bioresistant intracorporeal carbon-based nanocomposites in subjects exposed to a fulguration, in the immediate aftermath of this fulguration and 24 months (+/- 6 months) after the accident, on blood and urine samples, then in comparison with blood and urine samples from 14 healthy subjects.
Hypothesis: Lightning discharge in the human body reveals the presence of multi-functional nanoparticles which are reassembled under the impact of the electric discharge into nanostructured films, filaments and aggregates; they consist of dispersed graphene-like nanoparticles embedded in an aliphatic cross-reticulated matrix. The high electrical conductivity of the nanoinclusions, their refractory properties and the cross-reticulation of the nanoassemblages explain their biorésistance.
The graphene-like multi-functional nanoparticles are assumed to trace a population of aerosols formed in the atmosphere by plasma discharge which is present in air, water and all natural resources. Their ability to undergo changes from folded nanosheets to confined ultra-fine nanoparticles allow them to be inhaled or absorbed by the human body, or to be ingested with food.
详细描述
In order to detect nanocomposites in patients who have been impacted by lightning, an analysis protocol will be performed on the remains of blood and urine samples from their initial medical admission. After filtering the blood and urine samples, the remaining nanocomposites are selected for characterization, at micro to nanoscale, using the scanning electron microscope and the transmission electron microscope.
Based on laboratory experiments, a second sampling of blood and urine will be performed 24 months (+/-6 months) after the lightning strike to follow the delayed production of nanocomposites from the remaining activated nanoparticles.
- Presence of bioresistant nanocomposites in blood and urine at D0 and M24 (+/- 6 months) :
- If the victim was treated between H0 and H2 after the fulguration : an initial blood sample was taken by the SMUR or the emergency room and stored
- If the victim was treated between H0 and H6: urine sample was taken from the first urine after fulguration.
- At M24 (+/- 6 months) after the fulguration: collection of 18 ml of blood and two bottles of urine.
In order to describe the neurological disorders of the patients, initial clinical, biological and radiological data will be collected in the patients' medical records and a new clinical examination will be performed at 24 months (+/- 6 months) after fulguration.
-Search for descriptive data.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 7 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Description of bioresistant nanocomposites
时间窗: Month 24
Characterization in urine
次要结局
- neurological disorders(Month 24)
- neuropsychological disorders(Month 24)