New Reference Values for Intracranial Pressure

Study Overview
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Brief Summary
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Intracranial pressure is a cornerstone in neurosurgical care used in a variety of diseases. However currently, doubts regarding normal intracranial pressure exist. Few studies have investigated normal intracranial pressure in truly normal adults. The aim of this study is to investigate intracranial pressure in adults who have normal intracranial pressure physiology. In this prospective, multicenter, clinical study, the intracranial pressure of 10 adults requiring surgery for an unruptured aneurysm will be investigated. These patients are thought to be normal in terms of intracranial pressure physiology. At the end of their surgery for an aneurysm, a telemetric intracranial pressure monitoring sensor will be implanted. Afterward, intracranial pressure curves will be obtained non-invasively 1., 14., 30 and 90 days after implantation. The intracranial pressure will be investigated in 5 different positions (supine, lumbar, upright sitting, standing and walking). Furthermore, a 24-hour measurement will be performed in their home environment, thus investigating intracranial pressure under daily activities.

Official Title
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Challenging Reference Values for Intracranial Pressure: A Prospective, Multicenter, Clinical Study

Conditions
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Intracranial Pressure

Intervention / Treatment
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* Device: Raumedic Neurovent-P-tel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Above the age of 18 Requiring surgery for a cold (unruptured) aneurysm Exclusion Criteria: Current or previous examination or treatment for hydrocephalus Current or previous examination or treatment for idiopathic intracranial hypertension Previous operation with insertion of cerebrospinal fluid shunt Previous trauma with intracranial hemorrhage Global cerebral edema Increased infection risks Surgical complications during the primary operation Unable to understand patient information

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemetric intracranial pressure implant<br>A telemetric intracranial pressure monitoring sensor is inserted into the brain parenchyma at the end of an uncomplicated surgery for an unruptured aneurysm | Device: Raumedic Neurovent-P-tel<br>* Insertion of a Neurovent-P-tel in adults to study normal intracranial pressure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normal Intracranial Pressure Values | To determine reference values for intracranial pressure in healthy adults | Each participants will be monitored for three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intracranial pressure, ICP, Normal value, Reference value, Hydrocephalus