Intracranial Pressure IncreaseTCD ONSD TBINCT07816588
TCD and ONSD for Noninvasive Assessment of Increased ICP in TBI
An observational study of Intracranial Pressure Increase and Traumatic Brain Injuries, run by Ain Shams University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Intracranial Pressure Increase, Traumatic Brain Injuries
- What is being tested?
- Transcranial Doppler (TCD) and Optic Nerve Sheath Diameter (ONSD) Ultrasound
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Jun 2026to 7 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Being tested
- Transcranial Doppler (TCD), Optic Nerve Sheath Diameter (ONSD) Ultrasound
- Medical subject headings
- Intracranial Hypertension, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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) UltrasoundDiagnostic 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°.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Transcranial Doppler (TCD); Diagnostic Test: Optic Nerve Sheath Diameter (ONSD) Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline / initial assessment
Secondary outcomes (2)
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.
Measured: 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.
Measured: At baseline / initial assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start7 Jun 2026
- Primary completion7 Dec 2026 (estimated)
- Study completion7 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Intracranial Pressure IncreaseStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Khaled M Maghawry, Professor, Principal investigator, Ain Shams University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816588
- Sponsor's protocol ID
- FMASU MS 445/2026
- Acronym
- TCD ONSD TBI
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35198210Lioi 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.
PubMed 39209251Bellner 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.
PubMed 15226070Gomez 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.
PubMed 33554739Chang 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.
PubMed 34725957Hakeem 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.
PubMed 40353282
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07816588
- Acronym / sponsor ID
- TCD ONSD TBI / FMASU MS 445/2026
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 7 Jun 2026 (actual)
- Primary completion
- 7 Dec 2026 (estimated)
- Study completion
- 7 Dec 2026 (estimated)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Traumatic Brain Injury Patients | – | Diagnostic Test: Transcranial Doppler (TCD), Diagnostic Test: Optic Nerve Sheath Diameter (ONSD) UltrasoundAdults 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Doppler (TCD)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. | Diagnostic test | Traumatic Brain Injury Patients |
| Optic Nerve Sheath Diameter (ONSD) UltrasoundOptic 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 test | Traumatic Brain Injury Patients |
Primary outcome
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.
2 secondary outcomes
Correlation of TCD pulsatility index with severity of CT brain findings
Time frame: At baseline / initial assessment
Correlation of optic nerve sheath diameter with severity of CT brain findings
Time frame: At baseline / initial assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Results publication: PubMed 35198210Sitanaya 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.
- Results publication: PubMed 39209251Lioi 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.
- Results publication: PubMed 15226070Bellner 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.
- Results publication: PubMed 33554739Gomez 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.
- Results publication: PubMed 34725957Chang 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.
- Results publication: PubMed 40353282Hakeem 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khaled M Maghawry, Professor principal investigator
Ain Shams University, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Pressure Increase and Traumatic Brain Injuries, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07816588, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.