跳至主要内容
临床试验/NCT06629168
NCT06629168已完成不适用

Usage of Telemetric Prechamber Sensor Reservoir in Management of Hydrocephalus

University Hospital Hradec Kralove1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2018年1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
33
试验地点
1
主要终点
Comparison of patient's state

研究概览

简要总结

Normal pressure hydrocephalus (NPH) is a preventable and treatable cause of dementia. However, as a nosological entity, it is significantly underdiagnosed, often being mistakenly classified as presenile or senile dementia without further investigation. Ongoing management is crucial, currently relying mainly on indirect methods-clinical and imaging-based. Telemetry offers a real-time, online method to assess actual cerebrospinal fluid pressures, which are crucial for patient management. Telemetry allows for tailoring treatment to the individual patient. This project is planned as a pilot study before a more extensive research project.

详细描述

Normal pressure hydrocephalus (NPH) is a preventable and treatable cause of dementia. However, as a nosological entity, it is significantly underdiagnosed, often being mistakenly classified as presenile or senile dementia without further investigation. Diagnosing NPH is not straightforward; it is based on a series of examinations, the results of which determine whether the patient is a responder and therefore a candidate for shunt surgery (implantation of a ventriculoperitoneal shunt). The medical literature identifies additional criteria that predict whether the implantation of the shunt will have a good or poor effect. However, treatment from a neurosurgical perspective does not end there. Ongoing management is crucial, currently relying mainly on indirect methods-clinical and imaging-based. Telemetry offers a real-time, online method to assess actual cerebrospinal fluid pressures, which are crucial for patient management. Telemetry allows for tailoring treatment to the individual patient. This project is planned as a pilot study before a more extensive research project.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

入排标准

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

入选标准

  • Patients with diagnosed communicating hydrocephalus
  • mini-mental state examination test > 10 points
  • Absence of any structural lesion on MRI or CT
  • Accepted Informed consent

排除标准

  • Non-communicating hydrocephalus
  • Structural lesion on MRI or CT (tumour, contusion, aneurysm)
  • mini-mental state examination test < 10 points
  • Life-expectancy shorter than 1 year
  • Pre-existing other type of dementia (m. Alzheimer, vascular dementia)
  • Surgery lasting more than 120 minutes
  • Blood loss more than 500 ml
  • Adverse events during general anesthesia: mean arterial pressure < 60 mm Hg more than 5 minutes, arrythmia with need for pharmacological treatment

结局指标

主要结局

Comparison of patient's state

时间窗: 3 month

Comparison of mini-mental state examination, gait (measured by 5-meter-walking) test a self-assessment made by patient between both group (telemetric prechamber impanted versus not implanted)

次要结局

  • Comparison in radiological findings(1 year)
  • Comparison in number of valve setting(1 year)
  • Comparison of difference in valve settings(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Miroslav Cihlo

Principal Investigator

University Hospital Hradec Kralove

研究点 (1)

Loading locations...

相似试验