Clinical trial NCT02361671: Optic Nerve Sheath Diameter in Patients With Intracranial Pathology
Official title: Ultrasonographic Assessment of the Optic Nerve Sheath Diameter in Patients With Intracranial Pathology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Elevated Intracranial Pressure (ICP)
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2015-02-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intracranial pathology patients scheduled for elective or emergency surgery.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Optic Nerve Sheath Diameter, as measured by ultrasound of the optic nerve"
timeFrame: 6-8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Dinsmore Michael, MD
role: PRINCIPAL_INVESTIGATOR
References: