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Clinical Trials/NCT03594136
NCT03594136
Completed
Not Applicable

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

Rigshospitalet, Denmark3 sites in 2 countries6 target enrollmentFebruary 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intracranial Pressure
Sponsor
Rigshospitalet, Denmark
Enrollment
6
Locations
3
Primary Endpoint
Normal Intracranial Pressure Values
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2018
End Date
May 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nicolas Alexander Norager

Researh Assistant

Rigshospitalet, Denmark

Eligibility Criteria

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

Outcomes

Primary Outcomes

Normal Intracranial Pressure Values

Time Frame: Each participants will be monitored for three months

To determine reference values for intracranial pressure in healthy adults

Study Sites (3)

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