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NCT Number: NCT07816588

TCD and ONSD for Noninvasive Assessment of Increased ICP in TBI

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Intracranial Pressure Increase Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Intracranial Hypertension Nervous System Diseases Trauma, Nervous System Traumatic Brain Injuries Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ain-Shams University Hospitals

Cairo, Cairo Governorate, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcranial Doppler (TCD)

Diagnostic Test

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 (ONSD) Ultrasound

Diagnostic Test

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°.

Primary outcomes

  1. Diagnostic accuracy of TCD pulsatility index (PI) and optic nerve sheath diameter (ONSD) for detecting CT signs of increased intracranial pressure Description:

    Time frame: At baseline / initial assessment

    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.

Secondary outcomes

  1. Correlation of TCD pulsatility index with severity of CT brain findings

    Time frame: At baseline / initial assessment

    The relationship between TCD parameters, particularly pulsatility index, and the severity of CT brain findings will be assessed using the Marshall CT classification.

  2. Correlation of optic nerve sheath diameter with severity of CT brain findings

    Time frame: At baseline / initial assessment

    The relationship between ONSD measurements and the severity of CT brain findings will be assessed using the Marshall CT classification.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Efficacy of Trans-cranial Doppler and Optic Nerve Sheath Diameter Compared to CT Brain in Assessment of Increased Intracranial Pressure in Traumatic Brain Injury

Acronym: TCD ONSD TBI

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 11, 2026
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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