Optic Nerve Sheath Diameter in Patients With Intracranial Pathology

NCT02361671 | Completed

• 1 other identifier: 14-8172
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Elevated Intracranial Pressure (ICP)

Outcome Measures

Primary Outcomes (1)

• Optic Nerve Sheath Diameter, as measured by ultrasound of the optic nerve"

  6-8 weeks

Interventions

Optic Nerve Sheath Diameter using an ultrasound OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Intracranial pathology patients scheduled for elective or emergency surgery.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T2S8, Canada

Location

MeSH Terms

Conditions

Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Dinsmore Michael, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2015
• First Posted: February 12, 2015
• Study Start: February 1, 2015
• Primary Completion: May 31, 2023
• Study Completion: June 30, 2023
• Last Updated: August 28, 2023

Record last verified: 2023-08

Locations

CA (1)