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Sonography of the Optic Nerve Sheath Diameter for Detection of Elevated Intracranial Ressure (ICP)

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ClinicalTrials.gov Identifier: NCT03529370
Recruitment Status : Recruiting
First Posted : May 18, 2018
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Islam Hassan Mohamed Elsadek Abulnaga, National Heart Institute, Egypt

Brief Summary:
In this study the invistigators chose to measure the optic nerve sheath diameter by sonography for diagnosis of elevated intracranial pressure (ICP) in comparison to brain computed tomograhy (CT) as the reference gold standard for detection of raised ICP since optic nerve songraphy is radiation-free , noninvasive, and has certain features which increase its convenience portability, easy application, low cost, repeatability on request, bedside application, short application time and applicability even in the presence of unstable vital signs.

Condition or disease Intervention/treatment
Intracranial Hypertension Radiation: optic nerve ultrasound

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sonography of the Optic Nerve Sheath Diameter for Detection of Elevated Intracranial Pressure Compared to Computed Tomography
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound


Intervention Details:
  • Radiation: optic nerve ultrasound
    sonograhy of the optic nerve sheath diameter


Primary Outcome Measures :
  1. To measure the optic nerve sheath diameter by optic nerve ultrasound in patients with elevated ICP before and after osmotherapy and to measure the accuracy of occular ultrasound in diagnosis of elevated ICP compared to cranial computed tomography (CT) [ Time Frame: up to 48 hours ]
    Cranial CT and optic nerve US will be done once elevated ICP is suspected clinically to find signs of elevated ICP in cranial CT and measure the optic nerve sheath diameter by optic nerve ultrasound and then follow up optic nerve sonograhy and cranial CT will be done after 48 hours of giving osmotheray to detect the effect of osmotherapy on signs of elevated ICP in cranial CT and on the optic nerve sheath diameter



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

100 adult patients with clinically suspected raised ICP such as:

  1. Patients with traumatic brain injury
  2. Patients with intracranial tumours
  3. Patients with hepatic encephalopathy
  4. Cerebral edema: Due to head injury, ischemic stroke with vasogenic edema, hypoxic or ischemic encephalopathy, postoperative edema
Criteria

Inclusion Criteria:

  • Patients with clinically suspected raised ICP such as:

    1. Patients with traumatic brain injury
    2. Patients with intracranial tumours
    3. Patients with hepatic encephalopathy
    4. Cerebral edema: Due to head injury, ischemic stroke with vasogenic edema, hypoxic or ischemic encephalopathy, postoperative edema

Exclusion Criteria:

  • Patients with edema or trauma in the eye lid.

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): NCT03529370


Contacts
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Contact: Islam H Abulnaga, master 00201065098878 islamabulnaga@yahoo.com
Contact: Faten F Awadallah, MD 00201005586659 faten-icu@hotmail.com

Locations
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Egypt
National heart institute , Imbaba Recruiting
Cairo, Egypt, 12345
Contact: Faten F wadallah, MD    00201005586659    faten-icu@hotmai.com   
Contact: Islam H Abulnaga, Master    00201065098878    islamabulnaga@yahoo.com   
Sponsors and Collaborators
National Heart Institute, Egypt
Investigators
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Study Director: Mohamed H Abdallah, MD Cairo University
Study Director: Suzy F Michael, MD Cairo University
Study Director: Hassan K Nagi, MD Cairo University

Publications:
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Responsible Party: Islam Hassan Mohamed Elsadek Abulnaga, Specialist of critical care medicine, National heart institute, Cairo, Egypt, National Heart Institute, Egypt
ClinicalTrials.gov Identifier: NCT03529370     History of Changes
Other Study ID Numbers: Optic nerve sonography and ICP
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intracranial Hypertension
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases