Increase Intra Cranial PressureNCT06884319
Diagnostic Accuracy of the Optic Nerve Deformability Index and Optic Nerve Sheath Diameter as a Noninvasive Predictor of Intracranial Pressure
An observational study of Increase Intra Cranial Pressure and Traumatic Brain Injury, run by Benha University at 1 site in Egypt.
Trial summary
The study will be carried out on 50 patients, dichotomized into high and normal ICP groups, and we will assess both ONSD and DI in all patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Increase Intra Cranial Pressure, Traumatic Brain Injury
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to 30 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will be carried out on 50 patients, dichotomized into high and normal ICP groups and we will assess both ONSD and DI in all patients.
Who may be able to join
- age 18 to 65 years
- increased ICP (e.g., TBI, sub arachnoid hemorrhage, intracranial hemorrhage)
- a Glasgow Coma scale=3-12 and requiring ICP monitoring via invasive methods (e.g. extra ventricular drain, lumber drain)
Who cannot join
- chronic hydrocephalus
- extensive local orbit trauma
- a pre-existing ocular disease affecting the optic nerve and/or orbital cavity
- hyperthyroidism with exophthalmia
- facial trauma affecting the orbits and/or eyeballs
- optic nerve trauma
Show all 9Show fewer
- signs of critically raised ICP, needing urgent surgery.
- hemodynamically unstable between ONSD acquisition and ICP measurement.
- receiving medication that would decrease ICP between ultrasound imaging and ICP measurement, i.e. mannitol, hypertonic saline or steroids.
Trial locations and contacts
1 site in 1 country.
About this study
The study will be carried out on 50 patients, dichotomized into high and normal ICP groups, and we will assess both ONSD and DI in all patients.
Read the detailed description
Operational Design:
Preparation:
Awake and alert patients should be briefed on the procedure. Obtunded, intubated, or heavily sedated patients should undergo a basic eye evaluation for signs and symptoms of globe rupture or hyphema. If there is evidence of globe rupture-including visible conjunctival or scleral defects, severe chemosis, 360-degree conjunctival hemorrhage, hypotony, or total hyphema-the procedure should be aborted to avoid further herniation of intraocular contents, and an ophthalmologist should be consulted. The patient's position should be determined by comfort and ease of examination, but the procedure will typically be performed in a supine to 30-degree "head-up" position. Although theoretical concerns may exist regarding changes in ICP and optic nerve sheath diameter (ONSD) relative to patient position and ventilator settings, these changes do not appear to manifest in vivo.
Methods:
- Optic Nerve Sheath Diameter (ONSD) Assessment: After applying a generous amount of ultrasound gel, the high-frequency ultrasound linear transducer should be placed over the eye in the transverse plane. The sonographer's hand should rest on a non-compressible surface (such as the patient's nose, midface, or forehead) to avoid direct pressure on the globe, discomfort, and anatomical distortion. Small movements in the nasal and temporal directions, followed by caudal and cephalic adjustments, should be performed to capture the optic nerve sheath in the same plane as the lens, thus avoiding an oblique image. Once the anechoic streak posterior to the optic disc is visualized, the image should be captured, and measurements can be taken from the saved image. The optic nerve is relatively cylindrical and symmetrical, which theoretically makes a single view acceptable for measurement. Point of Measurement for ONSD: Three millimeters from the optic disc, posterior to the globe, corresponds to the bulbous (widest) portion of the optic nerve and is the site of maximum pressure changes within the nerve. For each optic nerve, two measurements are made-one in the sagittal plane and the other in the transverse plane (by rotating the probe clockwise). The mean value obtained for both eyes is retained as the final ONSD value.
- Deformability Index (DI) Assessment:
The deformability index (DI) of the optic nerve sheath (ONS) can be assessed using ultrasound to evaluate changes in intracranial pressure (ICP). This technique involves observing how the optic nerve sheath diameter (ONSD) changes in response to pressure or dynamic forces. It is based on the hypothesis that raised ICP leads to increased stiffness of the ONS complex due to the accumulation of CSF, thereby reducing its ability to deform under cardiovascular pulsation. The Deformability Index (DI) was calculated according to the method described by Padayachy et al. (2016), which estimates the magnitude of motion (D1 and D2) in the lateral direction on both sides of the ONS over the cardiac cycle. This dimensionless parameter quantifies the deformation of the nerve sheath complex according to the formula.
The method depends on the manual initialization of two points. To reduce operator dependency, the initialization was standardized by drawing a central, straight line through the optic nerve axis, with perpendicular measurements of the DI at predefined depths from the sclera. Results at 3.0 mm, 3.5 mm, and 4.0 mm depths will be calculated, and the average values will be used in further analysis. For patients in whom ultrasound acquisitions from both eyes were obtained, the average of the left and right eyes was calculated and used as the DI value in further analysis.
Normal DI: Indicates a compliant optic nerve sheath, suggesting normal ICP. Reduced DI: Suggests decreased compliance of the optic nerve sheath, typically seen in elevated ICP due to rigid structures limiting deformation.
Administrative and Ethical Design:
Approval from the Research Ethics Committee of Benha Faculty of Medicine will be obtained. Informed written consent will be obtained from all patients or their first-degree relatives before participation. The consent will include information about the aim of the study, study design, site, timing, subject details, methods, and confidentiality.
- Keywords
- Optic nerve sheat diameter, Deformability index, Increase intra cranial pressure
- Medical subject headings
- Brain Injuries, Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
Detect increase intra cranial pressure
By detection of increase intra cranial pressure early and rabid by Ultrasound we can treat early and avoid side effects of invasive measures
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start1 Mar 2025
- Primary completion30 Jan 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Increase Intra Cranial PressureStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Mohamed Ali Ibrahim El sokkary, Benha University
- Investigators
- Ahmed Mostafa Abd El-hamed, Professor, Study director, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884319
- Sponsor's protocol ID
- MD 15_2_2025
- Status last verified
- Apr 2025
- First submitted
- 13 Mar 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of the Optic Nerve Deformability Index and Optic Nerve Sheath Diameter as a Noninvasive Predictor of Intracranial Pressure
- ClinicalTrials.gov ID
- NCT06884319
- Acronym / sponsor ID
- MD 15_2_2025
- Keywords
- Optic nerve sheat diameter, Deformability index, Increase intra cranial pressure
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will be carried out on 50 patients, dichotomized into high and normal ICP groups, and we will assess both ONSD and DI in all patients.
Detailed description
Operational Design:
Preparation:
Awake and alert patients should be briefed on the procedure. Obtunded, intubated, or heavily sedated patients should undergo a basic eye evaluation for signs and symptoms of globe rupture or hyphema. If there is evidence of globe rupture-including visible conjunctival or scleral defects, severe chemosis, 360-degree conjunctival hemorrhage, hypotony, or total hyphema-the procedure should be aborted to avoid further herniation of intraocular contents, and an ophthalmologist should be consulted. The patient's position should be determined by comfort and ease of examination, but the procedure will typically be performed in a supine to 30-degree "head-up" position. Although theoretical concerns may exist regarding changes in ICP and optic nerve sheath diameter (ONSD) relative to patient position and ventilator settings, these changes do not appear to manifest in vivo.
Methods:
- Optic Nerve Sheath Diameter (ONSD) Assessment: After applying a generous amount of ultrasound gel, the high-frequency ultrasound linear transducer should be placed over the eye in the transverse plane. The sonographer's hand should rest on a non-compressible surface (such as the patient's nose, midface, or forehead) to avoid direct pressure on the globe, discomfort, and anatomical distortion. Small movements in the nasal and temporal directions, followed by caudal and cephalic adjustments, should be performed to capture the optic nerve sheath in the same plane as the lens, thus avoiding an oblique image. Once the anechoic streak posterior to the optic disc is visualized, the image should be captured, and measurements can be taken from the saved image. The optic nerve is relatively cylindrical and symmetrical, which theoretically makes a single view acceptable for measurement. Point of Measurement for ONSD: Three millimeters from the optic disc, posterior to the globe, corresponds to the bulbous (widest) portion of the optic nerve and is the site of maximum pressure changes within the nerve. For each optic nerve, two measurements are made-one in the sagittal plane and the other in the transverse plane (by rotating the probe clockwise). The mean value obtained for both eyes is retained as the final ONSD value.
- Deformability Index (DI) Assessment:
The deformability index (DI) of the optic nerve sheath (ONS) can be assessed using ultrasound to evaluate changes in intracranial pressure (ICP). This technique involves observing how the optic nerve sheath diameter (ONSD) changes in response to pressure or dynamic forces. It is based on the hypothesis that raised ICP leads to increased stiffness of the ONS complex due to the accumulation of CSF, thereby reducing its ability to deform under cardiovascular pulsation. The Deformability Index (DI) was calculated according to the method described by Padayachy et al. (2016), which estimates the magnitude of motion (D1 and D2) in the lateral direction on both sides of the ONS over the cardiac cycle. This dimensionless parameter quantifies the deformation of the nerve sheath complex according to the formula.
The method depends on the manual initialization of two points. To reduce operator dependency, the initialization was standardized by drawing a central, straight line through the optic nerve axis, with perpendicular measurements of the DI at predefined depths from the sclera. Results at 3.0 mm, 3.5 mm, and 4.0 mm depths will be calculated, and the average values will be used in further analysis. For patients in whom ultrasound acquisitions from both eyes were obtained, the average of the left and right eyes was calculated and used as the DI value in further analysis.
Normal DI: Indicates a compliant optic nerve sheath, suggesting normal ICP. Reduced DI: Suggests decreased compliance of the optic nerve sheath, typically seen in elevated ICP due to rigid structures limiting deformation.
Administrative and Ethical Design:
Approval from the Research Ethics Committee of Benha Faculty of Medicine will be obtained. Informed written consent will be obtained from all patients or their first-degree relatives before participation. The consent will include information about the aim of the study, study design, site, timing, subject details, methods, and confidentiality.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be carried out on 50 patients, dichotomized into high and normal ICP groups and we will assess both ONSD and DI in all patients.
Key inclusion criteria (3 listed)
- age 18 to 65 years
- increased ICP (e.g., TBI, sub arachnoid hemorrhage, intracranial hemorrhage)
- a Glasgow Coma scale=3-12 and requiring ICP monitoring via invasive methods (e.g. extra ventricular drain, lumber drain)
Key exclusion criteria (9 listed)
- chronic hydrocephalus
- extensive local orbit trauma
- a pre-existing ocular disease affecting the optic nerve and/or orbital cavity
- hyperthyroidism with exophthalmia
- facial trauma affecting the orbits and/or eyeballs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detect increase intra cranial pressure
Time frame: 1 week
By detection of increase intra cranial pressure early and rabid by Ultrasound we can treat early and avoid side effects of invasive measures
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Mostafa Abd El-hamed, Professor study director
Benha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Increase Intra Cranial Pressure and Traumatic Brain Injury, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detect increase intra cranial pressure (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.