An observational study in Intracranial Pressure Increase and Traumatic Brain Injuries, sponsored by Ain Shams University. Active, not recruiting at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Ain Shams University · Observational
This study will evaluate two non-invasive ultrasound methods, transcranial Doppler (TCD) and optic nerve sheath diameter (ONSD) ultrasound, for detecting signs of increased intracranial pressure in adults with traumatic brain injury (TBI). The results of these methods will be compared with findings from brain computed tomography (CT), which will be used as the reference assessment.
The study will include 40 patients aged 18 to 60 years who are admitted to the intensive care unit with blunt traumatic brain injury and diffuse brain edema on their initial CT scan. TCD and ONSD measurements will be performed by trained operators, together with collection of clinical and physiological data.
The study will assess how accurately TCD and ONSD identify CT findings suggestive of increased intracranial pressure and will compare the diagnostic performance of the two methods. Measurements will also be assessed in relation to the severity of CT findings.
165 studies on the registry are indexed under Intracranial Hypertension; 36 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 76 observational studies indexed under Intracranial Hypertension.
Browse Intracranial Hypertension studies →Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population will consist of adult male and female patients aged 18-60 years who are admitted to the intensive care unit with blunt traumatic brain injury associated with diffuse brain edema on the initial CT brain scan. A total of 40 patients are planned for inclusion. Participants will undergo assessment using transcranial Doppler and optic nerve sheath diameter ultrasound, with comparison of these findings with CT brain findings suggestive of increased intracranial pressure.
Inclusion Criteria:
Age 18-60 years. Male and female patients. Patients admitted to the intensive care unit with blunt traumatic brain injury associated with diffuse brain edema on the initial CT brain scan.
Patient or legally authorized representative provides .
Exclusion Criteria:
Age less than 18 or greater than 60 years. History of vascular disease affecting brain vessels. Pregnant females. Inability to obtain adequate TCD signal from trans-temporal acoustic bone windows due to fusion of skull sutures or temporal bone injury.
Significant cardiovascular disease that may affect the TCD signal, such as significant arrhythmia.
History of cardiac arrest before admission. Blood flow velocity greater than 120 cm/sec in patients with subarachnoid hemorrhage, to exclude vasospasm as a cause of decreased blood flow.
Ocular trauma or orbital surgery that would interfere with ONSD measurement. Chronic hydrocephalus. History of Graves' disease with exophthalmos. History of disease affecting the optic nerve, such as glaucoma. Refusal of consent by the patient or legally authorized representative.
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.
Adults aged 18-60 years admitted to the intensive care unit with blunt traumatic brain injury and diffuse brain edema on the initial CT brain scan. Participants will undergo non-invasive assessment using transcranial Doppler (TCD) and optic nerve sheath diameter (ONSD) ultrasound. TCD measurements will include peak systolic velocity, end diastolic velocity, and pulsatility index from the middle cerebral arteries bilaterally. ONSD will be measured in both eyes. These findings will be compared with CT brain findings suggestive of increased intracranial pressure. Clinical and physiological data, including Glasgow Coma Scale, mean arterial pressure, PaCO₂, oxygen saturation, and ECG findings, will also be recorded.
Diagnostic Test: Transcranial Doppler (TCD) · Diagnostic Test: Optic Nerve Sheath Diameter (ONSD) Ultrasound
Transcranial Doppler ultrasound will be performed by a trained operator through the temporal acoustic window to assess the middle cerebral artery bilaterally. Measurements will be obtained at a depth of 45-60 mm, including peak systolic velocity, end diastolic velocity, and pulsatility index. A pulsatility index greater than 1.3 and end diastolic velocity less than 25 cm/s will be considered abnormal according to the study protocol.
Optic nerve sheath diameter will be measured by a trained operator using a high-frequency 5-15 MHz linear ultrasound probe. Measurements will be obtained from both eyes, with three measurements performed for each eye and the average recorded. The diameter will be measured 3 mm behind the globe with the patient supine and in a neutral head position, with the head of the bed elevated between 20° and 30°.
Diagnostic accuracy of TCD pulsatility index (PI) and optic nerve sheath diameter (ONSD) for detecting CT signs of increased intracranial pressure Description:
Diagnostic performance of TCD-PI and ONSD measurements will be assessed by comparing them with signs of increased intracranial pressure on the initial CT brain scan. Sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating characteristic curve (AUC) will be calculated. The optimal cut-off values will be determined using the Youden index.
Time frame: At baseline / initial assessment
Correlation of TCD pulsatility index with severity of CT brain findings
The relationship between TCD parameters, particularly pulsatility index, and the severity of CT brain findings will be assessed using the Marshall CT classification.
Time frame: At baseline / initial assessment
Correlation of optic nerve sheath diameter with severity of CT brain findings
The relationship between ONSD measurements and the severity of CT brain findings will be assessed using the Marshall CT classification.
Time frame: At baseline / initial assessment
Plan to share: No
Started Jun 2026 (actual). Primary completion is estimated for Dec 2026, 6 months after the start.
Of 42 non-industry observational studies under Intracranial Hypertension, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 62. This study's planned 6 months is below that.
Counting every sponsor, half of 44 studies reached it within 31 months; a quarter within 11 and three quarters within 62.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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