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Optic Nerve Sheath Diameter in Patients With Intracranial Pathology

This study is currently recruiting participants.
Verified October 2017 by Lashmi Venkatraghavan, University Health Network, Toronto
Sponsor:
ClinicalTrials.gov Identifier:
NCT02361671
First Posted: February 12, 2015
Last Update Posted: October 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
University Health Network, Toronto
Information provided by (Responsible Party):
Lashmi Venkatraghavan, University Health Network, Toronto
  Purpose

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 Intervention
Elevated Intracranial Pressure (ICP) Other: Optic Nerve Sheath Diameter using an ultrasound

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ultrasonographic Assessment of the Optic Nerve Sheath Diameter in Patients With Intracranial Pathology

Resource links provided by NLM:


Further study details as provided by Lashmi Venkatraghavan, University Health Network, Toronto:

Primary Outcome Measures:
  • Optic Nerve Sheath Diameter, as measured by ultrasound of the optic nerve" [ Time Frame: upto 6-8 weeks ]

Estimated Enrollment: 100
Study Start Date: February 2015
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Intracranial pathology patients scheduled for elective or emergency surgery.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02361671


Locations
Canada, Ontario
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T2S8
Contact: Lashmi Venkatraghavan, MD    4166035118    lashmi.venkatraghavan@uhn.ca   
Principal Investigator: Dr Lashmi Venkatraghavan, MD         
Sub-Investigator: Dr Vincent Chan, MD         
Sub-Investigator: Dr. Michael Dinsmore, MD         
Sub-Investigator: Dr. Jigesh Mehta, MD         
Sponsors and Collaborators
Lashmi Venkatraghavan
University Health Network, Toronto
  More Information

Responsible Party: Lashmi Venkatraghavan, Assistant Professor, Department of Anesthesia, Toronto Western Hospital, Toronto, Canada, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02361671     History of Changes
Other Study ID Numbers: UHN REB # 14-8172
First Submitted: February 3, 2015
First Posted: February 12, 2015
Last Update Posted: October 26, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Intracranial Hypertension
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases