New Reference Values for Intracranial Pressure

Rigshospitalet

Status: Completed

Conditions: Intracranial Pressure

Treatments: Device: Raumedic Neurovent-P-tel

Study type: Interventional

Funder types: Other

Identifiers

NCT03594136

P1NICP

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Telemetric intracranial pressure implant

Experimental group

Description:

A telemetric intracranial pressure monitoring sensor is inserted into the brain parenchyma at the end of an uncomplicated surgery for an unruptured aneurysm

Treatment:

Device: Raumedic Neurovent-P-tel