Optic Nerve Sheath Diameter in Patients With Intracranial Pathology

August 24, 2023 updated by: University Health Network, Toronto

Ultrasonographic Assessment of the Optic Nerve Sheath Diameter in Patients With Intracranial Pathology

Elevated intracranial pressure (ICP) is a common and potentially life threatening condition arising from a variety of pathological conditions. The ability to monitor ICP is a crucial aspect in the management of these patients. Currently, the diagnosis of whether ICP is elevated or not is determined either with clinical signs (headache, nausea and vomiting or visual disturbances) or from the changes in the preoperative neuroimaging modalities such as computerized tomography (CT scan) and/or magnetic resonance imaging (MRI).

Recently, transorbital ultrasonography has gained popularity as a noninvasive bedside exam that has been shown to be useful in the diagnosis of raised ICP by evaluating the change in the optic nerve sheath diameter (ONSD).

The aim of our study is to use transorbital ultrasound to evaluate ONSD changes in patients with intracranial pathology and to compare the changes in the ONSD before and after surgical intervention as well as between patients with and without clinical or radiological signs of increased ICP.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Elevated intracranial pressure (ICP) is a common and potentially life threatening condition arising from a variety of pathological conditions. The ability to monitor ICP is a crucial aspect in the management of these patients. Currently, the diagnosis of whether ICP is elevated or not is determined either with clinical signs (headache, nausea and vomiting or visual disturbances) or from the changes in the preoperative neuroimaging modalities such as computerized tomography (CT scan) and/or magnetic resonance imaging (MRI).

Recently, transorbital ultrasonography has gained popularity as a noninvasive bedside exam that has been shown to be useful in the diagnosis of raised ICP by evaluating the change in the optic nerve sheath diameter (ONSD).

The aim of our study is to use transorbital ultrasound to evaluate ONSD changes in patients with intracranial pathology and to compare the changes in the ONSD before and after surgical intervention as well as between patients with and without clinical or radiological signs of increased ICP.

Study Type

Observational

Enrollment (Actual)

100

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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T2S8
        • Toronto Western Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Intracranial pathology patients scheduled for elective or emergency surgery.

Description

Inclusion Criteria:

  • Intracranial pathology patients scheduled for elective or emergency surgery.
  • American Anesthesiologist Society physical status classification system (ASA) 1-4

Exclusion Criteria:

  • history of Glaucoma,
  • previous retinal surgery,
  • optic neuritis,
  • lack of informed consent,
  • pregnancy

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Optic Nerve Sheath Diameter, as measured by ultrasound of the optic nerve"
Time Frame: 6-8 weeks
6-8 weeks

Collaborators and Investigators

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

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Dinsmore Michael, MD, University Health Network, Toronto

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)

February 1, 2015

Primary Completion (Actual)

May 31, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

February 3, 2015

First Submitted That Met QC Criteria

February 6, 2015

First Posted (Estimated)

February 12, 2015

Study Record Updates

Last Update Posted (Actual)

August 28, 2023

Last Update Submitted That Met QC Criteria

August 24, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-8172

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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