NCT07816588Active, not recruiting
TCD and ONSD for Noninvasive Assessment of Increased ICP in TBI
Efficacy of Trans-cranial Doppler and Optic Nerve Sheath Diameter Compared to CT Brain in Assessment of Increased Intracranial Pressure in Traumatic Brain Injury
Source: ClinicalTrials.gov · Last updated 11 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 40 (estimated)
- First submitted
- 8 Sept 2026
- Start date
- 7 Jun 2026
- Primary completion date
- 7 Dec 2026
- Lead sponsor
- Ain Shams University
- NCT number
- NCT07816588
What you commit to
- Study type: Observational
- Planned participants: 40
- From 7 Jun 2026 to the primary completion date, 7 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Age
- 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.
Who the study is looking for
- 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 informed consent.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ain Shams University Hospitals Coordinator of this site? Confirm its status | Cairo | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.