Usage of Telemetric Prechamber Sensor Reservoir in Management of Hydrocephalus
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
- 否
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
Miroslav Cihlo
Principal Investigator
University Hospital Hradec Kralove