The Usage of Telemetric Prechamber Sensor Reservoir in Management of Normal Pressure Hydrocephalus. Comparisson of Benefit for Patients with Implanted Telemetric Prechamber Sensor Reservoir.
- Conditions
- HydrocephalusNormal Pressure HydrocephalusNormal Pressure Hydrocephalus Patients
- Interventions
- Diagnostic Test: lumbar punctureDiagnostic Test: External lumbar drainageProcedure: Ventriculo-peritoneal shunt placementDiagnostic Test: Follow-up control #1Diagnostic Test: Follow-up control #2Diagnostic Test: Follow-up control #3Diagnostic Test: Follow-up control #4Diagnostic Test: Telemetric prechamber readingOther: Valve setting change
- Registration Number
- NCT06629168
- Lead Sponsor
- University Hospital Hradec Kralove
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- Patients with diagnosed communicating hydrocephalus
- mini-mental state examination test > 10 points
- Absence of any structural lesion on MRI or CT
- Accepted Informed consent
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Study group "Telemetrics" lumbar puncture Patients with diagnosed hydrocephalus undergoing surgery (VP shunt placement) in general anesthesia. During surgery telemetrical prechamber implantad. Study group "Telemetrics" External lumbar drainage Patients with diagnosed hydrocephalus undergoing surgery (VP shunt placement) in general anesthesia. During surgery telemetrical prechamber implantad. Study group "Telemetrics" Telemetric prechamber reading Patients with diagnosed hydrocephalus undergoing surgery (VP shunt placement) in general anesthesia. During surgery telemetrical prechamber implantad. Study group "Telemetrics" Valve setting change Patients with diagnosed hydrocephalus undergoing surgery (VP shunt placement) in general anesthesia. During surgery telemetrical prechamber implantad. Study group "Normal" lumbar puncture Patients with diagnosed hydrocephalus undergoing surgery (VP shunt placement) in general anesthesia. During surgery telemetrical prechamber not implantad. Study group "Normal" External lumbar drainage Patients with diagnosed hydrocephalus undergoing surgery (VP shunt placement) in general anesthesia. During surgery telemetrical prechamber not implantad. Study group "Normal" Follow-up control #1 Patients with diagnosed hydrocephalus undergoing surgery (VP shunt placement) in general anesthesia. During surgery telemetrical prechamber not implantad. Study group "Normal" Follow-up control #2 Patients with diagnosed hydrocephalus undergoing surgery (VP shunt placement) in general anesthesia. During surgery telemetrical prechamber not implantad. Study group "Normal" Follow-up control #3 Patients with diagnosed hydrocephalus undergoing surgery (VP shunt placement) in general anesthesia. During surgery telemetrical prechamber not implantad. Study group "Normal" Follow-up control #4 Patients with diagnosed hydrocephalus undergoing surgery (VP shunt placement) in general anesthesia. During surgery telemetrical prechamber not implantad. Study group "Normal" Valve setting change Patients with diagnosed hydrocephalus undergoing surgery (VP shunt placement) in general anesthesia. During surgery telemetrical prechamber not implantad. Study group "Telemetrics" Ventriculo-peritoneal shunt placement Patients with diagnosed hydrocephalus undergoing surgery (VP shunt placement) in general anesthesia. During surgery telemetrical prechamber implantad. Study group "Telemetrics" Follow-up control #1 Patients with diagnosed hydrocephalus undergoing surgery (VP shunt placement) in general anesthesia. During surgery telemetrical prechamber implantad. Study group "Telemetrics" Follow-up control #2 Patients with diagnosed hydrocephalus undergoing surgery (VP shunt placement) in general anesthesia. During surgery telemetrical prechamber implantad. Study group "Telemetrics" Follow-up control #3 Patients with diagnosed hydrocephalus undergoing surgery (VP shunt placement) in general anesthesia. During surgery telemetrical prechamber implantad. Study group "Telemetrics" Follow-up control #4 Patients with diagnosed hydrocephalus undergoing surgery (VP shunt placement) in general anesthesia. During surgery telemetrical prechamber implantad. Study group "Normal" Ventriculo-peritoneal shunt placement Patients with diagnosed hydrocephalus undergoing surgery (VP shunt placement) in general anesthesia. During surgery telemetrical prechamber not implantad.
- Primary Outcome Measures
Name Time Method Comparison of patient's state 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)
- Secondary Outcome Measures
Name Time Method Comparison in radiological findings 1 year Comparison of size of brain ventricles on brain CT examination at the end of follow-up between both groups
Comparison in number of valve setting 1 year Comparison in number of valve setting between both groups
Comparison of difference in valve settings 1 year Comparison of difference in valve settings - between pressure set in time of implantation and at the end of follow up
Trial Locations
- Locations (1)
University Hospital Hradec Kralove
🇨🇿Hradec Králové, Czech Republic