TCD and ONSD for Noninvasive Assessment of Increased ICP in TBI

NCT07816588 | Active Not Recruiting

• 1 other identifier: FMASU MS 445/2026
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracranial Pressure Increase; Traumatic Brain Injuries

Outcome Measures

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:

  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.

  At baseline / initial assessment

Secondary Outcomes (2)

• Correlation of TCD pulsatility index with severity of CT brain findings

  At baseline / initial assessment

• Correlation of optic nerve sheath diameter with severity of CT brain findings

  At baseline / initial assessment

Study Arms (1)

Traumatic Brain Injury Patients

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

Interventions

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.

Traumatic Brain Injury Patients

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°.

Traumatic Brain Injury Patients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain-Shams University Hospitals

Cairo, Cairo Governorate, Egypt

Location

Related Publications (6)

• Sitanaya SN, Kamayanti F, Nugroho HA, Prabowo B. Comparing ultrasonographic optic nerve sheath diameter to head computed tomography scan to predict intracranial pressure elevation. SAGE Open Med. 2022 Feb 17;10:20503121221077834. doi: 10.1177/20503121221077834. eCollection 2022.

  PMID: 35198210 RESULT

• Lioi F, Ramm-Pettersen J, Fratini A, Riva C, Colella N, Missori P. Ultrasonographic Assessment of Optic Nerve Sheath Diameter as a Screening Tool for Intracranial Hypertension in Traumatic Brain Injury. World Neurosurg. 2024 Dec;192:e42-e48. doi: 10.1016/j.wneu.2024.08.111. Epub 2024 Aug 27.

  PMID: 39209251 RESULT

• Bellner J, Romner B, Reinstrup P, Kristiansson KA, Ryding E, Brandt L. Transcranial Doppler sonography pulsatility index (PI) reflects intracranial pressure (ICP). Surg Neurol. 2004 Jul;62(1):45-51; discussion 51. doi: 10.1016/j.surneu.2003.12.007.

  PMID: 15226070 RESULT

• Gomez A, Batson C, Froese L, Sainbhi AS, Zeiler FA. Utility of Transcranial Doppler in Moderate and Severe Traumatic Brain Injury: A Narrative Review of Cerebral Physiologic Metrics. J Neurotrauma. 2021 Aug 15;38(16):2206-2220. doi: 10.1089/neu.2020.7523. Epub 2021 Mar 1.

  PMID: 33554739 RESULT

• Chang T, Yan X, Zhao C, Zhang Y, Wang B, Gao L. Noninvasive evaluation of intracranial pressure in patients with traumatic brain injury by transcranial Doppler ultrasound. Brain Behav. 2021 Dec;11(12):e2396. doi: 10.1002/brb3.2396. Epub 2021 Nov 1.

  PMID: 34725957 RESULT

• Hakeem A, Anwer M, Khan AV, Kumar H, Karthikeyan V, Sridhar R, Kumar A, Kumar A, Kumar S. Optic Nerve Sheath Diameter Estimation to Detect Increased Intracranial Pressure in Traumatic Brain Injury patients at a Level I Trauma Center in Eastern India. Korean J Neurotrauma. 2025 Apr 24;21(2):93-101. doi: 10.13004/kjnt.2025.21.e15. eCollection 2025 Apr.

  PMID: 40353282 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Intracranial Hypertension; Brain Injuries, Traumatic

Interventions

Ultrasonography, Doppler, Transcranial; Ultrasonography

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Khaled M Maghawry, Professor

  Ain Shams University, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 11, 2026
• Study Start: June 7, 2026
• Primary Completion (Estimated): December 7, 2026
• Study Completion (Estimated): December 7, 2026
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)