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OpenTrials
Completed

NCT Number: NCT03594136

New Reference Values for Intracranial Pressure

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.

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Key information

Conditions

Intracranial Pressure Brain Diseases Central Nervous System Diseases Hydrocephalus Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Military University Hospital Prague, Prague, Czechia

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Raumedic Neurovent-P-tel

Device

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

Primary outcomes

  1. Normal Intracranial Pressure Values

    Time frame: Each participants will be monitored for three months

    To determine reference values for intracranial pressure in healthy adults

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Lundbeck Foundation

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jul 20, 2018
Registry last updated
Jan 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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