Optic Nerve Sheath Diameter in Patients With Intracranial Pathology

Elevated Intracranial Pressure (ICP) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02361671
• Other study ID #: 14-8172
• Status: Completed
• Start date: February 2015
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2023
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 30, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Elevated Intracranial Pressure (ICP)
• Intracranial Hypertension

Intervention

Other:
• Optic Nerve Sheath Diameter using an ultrasound
Optic nerve sheath diameter will be measured by ultrasound preoperatively on the day of surgery, Immediate postoperative period (within 24 hours) or 6-8 weeks after surgery on the follow-up visit.

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optic Nerve Sheath Diameter, as measured by ultrasound of the optic nerve"		6-8 weeks