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

April 13, 2024 updated by: Gülşah ORAK, Istanbul University - Cerrahpasa (IUC)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Fatıh
      • Istanbul, Fatıh, Turkey, 34098
        • Istanbul University-Cerrahpasa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Before Drainage
Optic nerve sheath diameter and intracranial pressure will be measured before CSF drainage
Procedure: After 5 ml CSF Drainage
Optic Nerve Sheath Diameter and Intracranial Pressure measurements will be after 5 ml CSF drainage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intracranial Pressure-1 (ICP-1)
Time Frame: baseline time
Measurement of intracranial pressure before cerebrospinal fluid (CSF) drainage
baseline time
Optic Nerve Sheath Diameter-1 (ONSD-1)
Time Frame: baseline time
Measurement of optic nerve sheath diameter before cerebrospinal fluid drainage
baseline time

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intracranial Pressure-2 (ICP-2)
Time Frame: 2 minutes after CSF drainage
Measurement of intracranial pressure 2 minutes after cerebrospinal fluid (CSF) drainage
2 minutes after CSF drainage
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
2 minutes after CSF drainage

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Investigators

  • Study Director: GULSAH ORAK, Istanbul University - Cerrahpasa (IUC)
  • Study Chair: OZLEM KORKMAZ DİLMEN, Istanbul University - Cerrahpasa (IUC)
  • Study Chair: EREN FATMA AKCİL, Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2021

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

April 5, 2024

First Submitted That Met QC Criteria

April 13, 2024

First Posted (Actual)

April 16, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 13, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-83045809-604.01.02-179951

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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