New Reference Values for Intracranial Pressure

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03594136

Enrollment

Registered

2018-07-20

Start date

2018-02-01

Completion date

2023-05-01

Last updated

2024-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Pressure

Keywords

Intracranial pressure, ICP, Normal value, Reference value, Hydrocephalus

Brief summary

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.

Interventions

DEVICERaumedic Neurovent-P-tel

Insertion of a Neurovent-P-tel in adults to study normal intracranial pressure

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

Czechia, Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026