Challenging Reference Values for Intracranial Pressure: A Prospective, Multicenter, Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 3
- 主要终点
- Normal Intracranial Pressure Values
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Above the age of 18
- •Requiring surgery for a "cold" (unruptured) aneurysm
排除标准
- •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
研究组 & 干预措施
Telemetric intracranial pressure implant
A telemetric intracranial pressure monitoring sensor is inserted into the brain parenchyma at the end of an uncomplicated surgery for an unruptured aneurysm
干预措施: Raumedic Neurovent-P-tel (Device)
结局指标
主要结局
Normal Intracranial Pressure Values
时间窗: Each participants will be monitored for three months
To determine reference values for intracranial pressure in healthy adults
次要结局
未报告次要终点
研究者
Nicolas Alexander Norager
Researh Assistant
Rigshospitalet, Denmark