An observational study in Intracranial Hypertension, Increased Intracranial Pressure and Brain Edema, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Assiut University · Observational
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.
165 studies on the registry are indexed under Intracranial Hypertension; 36 are open to participants now.
This study's planned enrollment of 85 is above the median of 60 across 76 observational studies indexed under Intracranial Hypertension.
Browse Intracranial Hypertension studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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).
Time frame: baseline
No study locations are listed for this record.
Start is estimated for Oct 2026; primary completion for Oct 2027, 12 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.