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NCT03594136 Clinical Trial

New Reference Values for Intracranial Pressure

Intracranial Pressure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03594136
Other study ID # P1NICP
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2018
Est. completion date May 1, 2023

Study information
Verified date January 2024
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 6
Est. completion date May 1, 2023
Est. primary completion date May 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Raumedic Neurovent-P-tel
Insertion of a Neurovent-P-tel in adults to study normal intracranial pressure

Locations
Country Name City State
Czechia Military University Hospital Prague Prague
Denmark Aarhus University Hospital Aarhus
Denmark Rigshospitalet Copenhagen Copenhagen E

Sponsors (2)
Lead Sponsor Collaborator
Rigshospitalet, Denmark Lundbeck Foundation

Countries where clinical trial is conducted

Czechia,  Denmark, 

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