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Completed

NCT Number: NCT06367868

Optic Nerve Sheath Diameter: A Non-Invasive Indicator of Intracranial Pressure in the Intensive Care Unit Monitoring

Determination of high intracranial pressure (ICP) is necessary for the treatment of patients with raised ICP to improve long-term neurological outcomes. Ultrasonographic optic nerve sheath diameter (ONSD) measurement is a noninvasive, easily performed and cost effective technique for detecting high ICP.

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Key information

Conditions

ICP (Intracranial Pressure) Increase Brain Diseases Central Nervous System Diseases Intracranial Hypertension Nervous System Diseases Optic Nerve Sheath Diameter

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University-Cerrahpasa

Istanbul, Fatıh, 34098, Turkey (Türkiye)

About this study

ICP measurements via ventricular catheters provide CSF drainage and ICP reduction. The normal ICP value is less than 15 mmHg in adults. In the literature the correlation of ONSD and invasive ICP measurements were determined. The aim of study is to evaluate the correlation of ONSD and direct ICP measurements and to determine cut off ONSD value to detect ICP ≥15 mmHg.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18-80 aged patients
  • With an external ventricular drainage catheter due to intracranial pathology

Exclusion criteria

  • Under the age of 18
  • Orbital tumors
  • Graves' disease
  • Exophthalmos
  • Sarcoidosis
  • Optic neuropathy
  • Meningitis
  • Ocular trauma
  • Lung diseases

Treatment and study plan

After 5 ml CSF Drainage

Procedure

Optic Nerve Sheath Diameter and Intracranial Pressure measurements will be after 5 ml CSF drainage

Primary outcomes

  1. Intracranial Pressure-1 (ICP-1)

    Time frame: baseline time

    Measurement of intracranial pressure before cerebrospinal fluid (CSF) drainage

  2. Optic Nerve Sheath Diameter-1 (ONSD-1)

    Time frame: baseline time

    Measurement of optic nerve sheath diameter before cerebrospinal fluid drainage

Secondary outcomes

  1. Intracranial Pressure-2 (ICP-2)

    Time frame: 2 minutes after CSF drainage

    Measurement of intracranial pressure 2 minutes after cerebrospinal fluid (CSF) drainage

  2. Optic Nerve Sheath Diameter-2 (ONSD-2)

    Time frame: 2 minutes after CSF drainage

    Measurement of optic nerve sheath diameter 2 minutes after cerebrospinal fluid drainage

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

Evaluation of the Effect of Cerebrospinal Fluid Drainage on Optic Nerve Sheath Diameter in Patients Installed External Ventricular Drainage Catheter Due to Intracranial Pathology in the Intensive Care Unit

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 16, 2024
Registry last updated
Apr 16, 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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