Optic Nerve Sheath Diameter in Patients With Intracranial Pathology

• Sponsor: University Health Network, Toronto (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02361671
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Duration (Months): 82
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Elevated Intracranial Pressure (ICP)	Other: Optic Nerve Sheath Diameter using an ultrasound

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Ultrasonographic Assessment of the Optic Nerve Sheath Diameter in Patients With Intracranial Pathology
• Study Start Date: Feb 1, 2015
• Anticipated Primary Completion Date: May 1, 2021
• Anticipated Study Completion Date: Dec 1, 2021

Outcome Measures

Primary Outcome Measures

1. Optic Nerve Sheath Diameter, as measured by ultrasound of the optic nerve" [upto 6-8 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Toronto Western Hospital	Toronto	Ontario	Canada	M5T2S8

Sponsors and Collaborators

• University Health Network, Toronto

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michael Dinsmore, Staff Anesthesiologist, University Health Network, Toronto
• ClinicalTrials.gov Identifier: NCT02361671
• Other Study ID Numbers: UHN REB # 14-8172
• First Posted: Feb 12, 2015
• Last Update Posted: Nov 19, 2020
• Last Verified: Nov 1, 2020

• Additional relevant MeSH terms: Intracranial Hypertension

Study Results

No Results Posted as of Nov 19, 2020