Intracranial HypertensionNCT07799714
Bedside Ultrasound Measurement of Optic Nerve Sheath Diameter for Detecting Raised Intracranial Pressure
An observational study of Intracranial Hypertension and Increased Intracranial Pressure, run by Assiut University.
Trial summary
Raised intracranial pressure (ICP) is a serious medical emergency that requires prompt recognition to prevent brain damage. While invasive pressure monitoring and brain CT scans are commonly used, bedside transorbital ultrasonography to measure optic nerve sheath diameter (ONSD) offers a rapid, non-invasive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Hypertension, Increased Intracranial Pressure, Brain Edema
- How many people
- 85 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 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 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients aged 18 years or older admitted to the emergency department or intensive care units at Assiut University Hospital with clinical suspicion of acutely raised intracranial pressure (such as altered level of consciousness, progressive headache, vomiting, papilledema, or focal neurological deficits) who are referred to the Diagnostic Radiology Department for a non-contrast brain CT scan.
Who may be able to join
- Adults aged ≥ 18 years
- Clinical suspicion of acutely raised intracranial pressure (e.g., altered level of consciousness, papilledema, progressive headache, vomiting, or focal neurological deficits)
- Referred to undergo a brain CT scan
- Hemodynamically stable at the time of ultrasound examination
Who cannot join
- Pre-existing orbital or ocular trauma
- Known history of optic nerve disease (e.g., optic neuritis or glaucoma)
- Previous ocular or intraorbital surgery
- Severe ocular pathology preventing safe transorbital ultrasonographic assessment
- Refusal to participate or lack of informed consent from the patient or legal guardian
About this study
Official title: Role of Bedside Ultrasound Measurement of Optic Nerve Sheath Diameter in the Early Detection of Raised Intracranial Pressure: A Comparative Study With CT Brain Findings
Raised intracranial pressure (ICP) is a serious medical emergency that requires prompt recognition to prevent brain damage. While invasive pressure monitoring and brain CT scans are commonly used, bedside transorbital ultrasonography to measure optic nerve sheath diameter (ONSD) offers a rapid, non-invasive alternative.
The purpose of this study is to evaluate the diagnostic accuracy of bedside ultrasound measurement of ONSD in detecting raised ICP in adult patients, using brain CT scan findings as the reference standard.
Adult patients clinically suspected of having elevated intracranial pressure and referred for a brain CT scan will undergo a non-invasive bedside ocular ultrasound examination. The optic nerve sheath diameter will be measured in both eyes and compared with independent CT brain interpretations to assess sensitivity, specificity, and the optimal diagnostic cut-off value.
- Conditions
- Intracranial Hypertension, Increased Intracranial Pressure, Brain Edema, Traumatic Brain Injury
- Keywords
- Optic Nerve Sheath Diameter, ONSD, Point-of-Care Ultrasound, Bedside Ultrasonography, CT Brain, Diagnostic Accuracy
- Medical subject headings
- Intracranial Hypertension, Brain Edema, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients Suspected of Raised Intracranial Pressure | Adult patients aged 18 years or older with clinical suspicion of acutely raised intracranial pressure (e.g., altered consciousness, progressive headache, vomiting, papilledema, or focal neurological deficits) who are referred to undergo a non-contrast brain CT scan. ll enrolled participants undergo bedside transorbital high-resolution ultrasonography using a 7.5-15 MHz linear-array transducer to measure the optic nerve sheath diameter (ONSD) at 3 mm posterior to the globe in both eyes. Ultrasonographic findings are compared with non-contrast brain CT findings (the reference standard), which are independently evaluated by blinded neuroradiologists for signs of elevated intracranial pressure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Receiver Operating Characteristic Curve (AUC-ROC) for Detecting Raised Intracranial Pressure
The diagnostic performance of bedside transorbital optic nerve sheath diameter (ONSD) measurement in differentiating between patients with and without raised intracranial pressure will be evaluated using Receiver Operating Characteristic (ROC) curve analysis against the non-contrast brain CT reference standard. The Area Under the Curve (AUC) ranges from 0.5 (no discrimination) to 1.0 (perfect discrimination).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial HypertensionStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Medhat Mounir Khalifa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799714
- Sponsor's protocol ID
- ONSD Ultrasound in Raised ICP
- Status last verified
- Aug 2026
- First submitted
- 30 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Bedside Ultrasound Measurement of Optic Nerve Sheath Diameter in the Early Detection of Raised Intracranial Pressure: A Comparative Study With CT Brain Findings
- ClinicalTrials.gov ID
- NCT07799714
- Acronym / sponsor ID
- ONSD Ultrasound in Raised ICP
- Conditions
- Intracranial Hypertension, Increased Intracranial Pressure, Brain Edema, Traumatic Brain Injury
- Keywords
- Optic Nerve Sheath Diameter, ONSD, Point-of-Care Ultrasound, Bedside Ultrasonography, CT Brain, Diagnostic Accuracy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 2 Sep 2026 (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.
Raised intracranial pressure (ICP) is a serious medical emergency that requires prompt recognition to prevent brain damage. While invasive pressure monitoring and brain CT scans are commonly used, bedside transorbital ultrasonography to measure optic nerve sheath diameter (ONSD) offers a rapid, non-invasive alternative.
The purpose of this study is to evaluate the diagnostic accuracy of bedside ultrasound measurement of ONSD in detecting raised ICP in adult patients, using brain CT scan findings as the reference standard.
Adult patients clinically suspected of having elevated intracranial pressure and referred for a brain CT scan will undergo a non-invasive bedside ocular ultrasound examination. The optic nerve sheath diameter will be measured in both eyes and compared with independent CT brain interpretations to assess sensitivity, specificity, and the optimal diagnostic cut-off value.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Suspected of Raised Intracranial Pressure | – | –Adult patients aged 18 years or older with clinical suspicion of acutely raised intracranial pressure (e.g., altered consciousness, progressive headache, vomiting, papilledema, or focal neurological deficits) who are referred to undergo a non-contrast brain CT scan. ll enrolled participants undergo bedside transorbital high-resolution ultrasonography using a 7.5-15 MHz linear-array transducer to measure the optic nerve sheath diameter (ONSD) at 3 mm posterior to the globe in both eyes. Ultrasonographic findings are compared with non-contrast brain CT findings (the reference standard), which are independently evaluated by blinded neuroradiologists for signs of elevated intracranial pressure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged 18 years or older admitted to the emergency department or intensive care units at Assiut University Hospital with clinical suspicion of acutely raised intracranial pressure (such as altered level of consciousness, progressive headache, vomiting, papilledema, or focal neurological deficits) who are referred to the Diagnostic Radiology Department for a non-contrast brain CT scan.
Key inclusion criteria (4 listed)
- Adults aged ≥ 18 years
- Clinical suspicion of acutely raised intracranial pressure (e.g., altered level of consciousness, papilledema, progressive headache, vomiting, or focal neurological deficits)
- Referred to undergo a brain CT scan
- Hemodynamically stable at the time of ultrasound examination
Key exclusion criteria (5 listed)
- Pre-existing orbital or ocular trauma
- Known history of optic nerve disease (e.g., optic neuritis or glaucoma)
- Previous ocular or intraorbital surgery
- Severe ocular pathology preventing safe transorbital ultrasonographic assessment
- Refusal to participate or lack of informed consent from the patient or legal guardian
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
Area Under the Receiver Operating Characteristic Curve (AUC-ROC) for Detecting Raised Intracranial Pressure
Time frame: baseline
The diagnostic performance of bedside transorbital optic nerve sheath diameter (ONSD) measurement in differentiating between patients with and without raised intracranial pressure will be evaluated using Receiver Operating Characteristic (ROC) curve analysis against the non-contrast brain CT reference standard. The Area Under the Curve (AUC) ranges from 0.5 (no discrimination) to 1.0 (perfect discrimination).
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 2 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Hypertension and Increased Intracranial Pressure, run by Assiut University.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Area Under the Receiver Operating Characteristic Curve (AUC-ROC) for Detecting Raised Intracranial Pressure (time frame: baseline). 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 2 Sep 2026.