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临床试验/NCT04846738
NCT04846738已完成不适用

Comparative Interest of Transcranial Doppler and Quantitative Pupillometry as Neurological Prognostic Factors at 12 Months in Brain Damaged Patients (Stroke or Head Trauma) Admitted to Intensive Care Unit

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2021年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
73
试验地点
1
主要终点
Modified Rankin Score (mRS) (0-5)

研究概览

简要总结

Transcranial Doppler is performed daily in Intensive Care Unit in brain damaged patients. For a few years now, the measurement of the photomotor reflex by quantitative Pupillometry has been routinely performed in Intensive Care Units. The objective of this work is to see if Transcranial Doppler recorded parameters and Pupillary parameters are correlated to the neurological prognosis evaluated at 9 months by the Modified Rankin Score (mRS) and the Glasgow Outcome Scale Extended (GOS-E).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All brain damaged patients (stroke or head trauma)
  • Admitted to Intensive Care Unit since December 1, 2020

排除标准

  • Refusal by the patient or his/her legal representative.
  • Benefiting from legal protection

结局指标

主要结局

Modified Rankin Score (mRS) (0-5)

时间窗: Year: 1

Modified Rankin Score (mRS) measures the degree of disability following a stroke in a patient (level 0 for patients with no symptoms to level 5 for patients with major disability and total dependency)..

Glasgow Outcome Scale Extended (GOS-E) (1-8)

时间窗: Year: 1

Glasgow Outcome Scale Extended (GOS-E) measure the impact of brain injured (minimum at 1 (Dead) and maximum at 8 (Upper Good Recovery).

次要结局

  • Mean Systolic Velocity (VMS)(At inclusion)
  • Intra-Cranial Pressure (ICP)(At inclusion)
  • Pulsatility Index (PI)(At inclusion)
  • Tele-Diastolic Velocity (TDV)(At inclusion)
  • Basic pupil diameter(At inclusion)
  • Percentage of variation of the pupil diameter(At inclusion)
  • Latent and slope of the standard photomotor reflex(At inclusion)
  • Tissue Partial Oxygen Pressure (PtiO2)(At inclusion)
  • Bispectral Index (BIS)(At inclusion)
  • Richmond Agitation-Sedation Scale (RASS)(At inclusion)
  • Heart rate(At inclusion)
  • Blood pressure(At inclusion)
  • Natremia (mmol/l)(At inclusion)
  • Glycemia (mmol/l)(At inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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