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

NCT03529370 | Completed

• 1 other identifier: Optic nerve sonography and ICP
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracranial Hypertension

Outcome Measures

Primary Outcomes (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)

  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

  up to 48 hours

Interventions

optic nerve ultrasound RADIATION

sonograhy of the optic nerve sheath diameter

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patients with clinically suspected raised ICP such as:
• Patients with traumatic brain injury
• Patients with intracranial tumours
• Patients with hepatic encephalopathy
• Cerebral edema: Due to head injury, ischemic stroke with vasogenic edema, hypoxic or ischemic encephalopathy, postoperative edema

You may not qualify if:

• Patients with edema or trauma in the eye lid.

Sponsors & Collaborators

• National Heart Institute, Egypt: lead

Study Sites (1)

National heart institute , Imbaba

Cairo, 12345, Egypt

Location

Related Publications (2)

• Robba C, Cardim D, Tajsic T, Pietersen J, Bulman M, Rasulo F, Bertuetti R, Donnelly J, Xiuyun L, Czosnyka Z, Cabeleira M, Smielewski P, Matta B, Bertuccio A, Czosnyka M. Non-invasive Intracranial Pressure Assessment in Brain Injured Patients Using Ultrasound-Based Methods. Acta Neurochir Suppl. 2018;126:69-73. doi: 10.1007/978-3-319-65798-1_15.

  PMID: 29492535 BACKGROUND

• Wang LJ, Chen LM, Chen Y, Bao LY, Zheng NN, Wang YZ, Xing YQ. Ultrasonography Assessments of Optic Nerve Sheath Diameter as a Noninvasive and Dynamic Method of Detecting Changes in Intracranial Pressure. JAMA Ophthalmol. 2018 Mar 1;136(3):250-256. doi: 10.1001/jamaophthalmol.2017.6560.

  PMID: 29392301 BACKGROUND

MeSH Terms

Conditions

Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Mohamed H Abdallah, MD

  Cairo University

  STUDY DIRECTOR

• Suzy F Michael, MD

  Cairo University

  STUDY DIRECTOR

• Hassan K Nagi, MD

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist of critical care medicine, National heart institute, Cairo, Egypt

Study Record Dates

• First Submitted: May 7, 2018
• First Posted: May 18, 2018
• Study Start: January 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: October 1, 2019
• Last Updated: February 27, 2020

Record last verified: 2020-02

Locations

EG (1)