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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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07816588
Acronym
TCD ONSD TBI
Enrollment
40
Registered
2026-09-11
Start date
2026-06-07
Completion date
2026-12-07
Last updated
2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Pressure Increase, Traumatic Brain Injuries

Brief summary

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.

Interventions

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°.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* 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.

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.

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic accuracy of TCD pulsatility index (PI) and optic nerve sheath diameter (ONSD) for detecting CT signs of increased intracranial pressure Description:At baseline / initial assessmentDiagnostic 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.

Secondary

MeasureTime frameDescription
Correlation of TCD pulsatility index with severity of CT brain findingsAt baseline / initial assessmentThe relationship between TCD parameters, particularly pulsatility index, and the severity of CT brain findings will be assessed using the Marshall CT classification.
Correlation of optic nerve sheath diameter with severity of CT brain findingsAt baseline / initial assessmentThe relationship between ONSD measurements and the severity of CT brain findings will be assessed using the Marshall CT classification.

Countries

Egypt

Contacts

PRINCIPAL_INVESTIGATORKhaled M Maghawry, Professor

Ain Shams University, Faculty of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026