Assessment of ONSD, ODE and the Crescent Sign Using POCUSNCT07719842
Diagnostic Accuracy of ONSD, ODE, and the Crescent Sign
A study testing Ultrasound assessment in people with Assessment of ONSD, ODE and the Crescent Sign Using POCUS, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Our aim was to determine the diagnostic accuracy of the ONSD, ODE, and crescent sign, as detected by POCUS, in identifying the clinical and radiological features of increased intracranial pressure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Assessment of ONSD, ODE and the Crescent Sign Using POCUS
- What is being tested?
- Ultrasound assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2026to 31 Jan 2027
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients presenting at the ED with any symptoms, who have undergone a cranial CT or cranial MRI for the diagnosis of cranial pathologies, and who do not meet the exclusion criteria
Who cannot join
- Patients under the age of 18
- Patients who have not undergone a cranial CT or cranial MRI
- Patients with orbital injuries
- Patients in whom ultrasonographic measurements cannot be performed
- Patients brought to ED following a cardiac arrest
- Patients who do not consent to diagnosis and treatment of their own volition
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Recep Tayyip Erdoğan University Rize Training and Research Hospital
Rize, Centrale, 53020
Mümin M Yazici, Specialist, +9005364971612, mmuratyazici53@gmail.com
About this study
Official title: Diagnostic Accuracy of ONSD, ODE, and the Crescent Sign on Ultrasound for Identifying Increased Intracranial Pressure: A Multicenter Study
Our aim was to determine the diagnostic accuracy of the ONSD, ODE, and crescent sign, as detected by POCUS, in identifying the clinical and radiological features of increased intracranial pressure.
Read the detailed description
All participants presenting to the ED with various symptoms and undergoing cranial CT or MRI for the diagnosis of cranial pathologies who do not meet the exclusion criteria will be included in the study. Informed consent will be obtained from all patients prior to the study. For participants included in the study, the presence of ONSD, ODE, and the crescent sign will be assessed using bedside ultrasound, and the diagnostic value of these findings will be evaluated. The bedside ultrasound will form part of the critical area examination in the emergency department; it will incur no cost to the institution and will be performed and assessed by an emergency medicine specialist and their assistant.
- Being tested
- Ultrasound assessment
- Keywords
- POCUS, ONSD, ODE, crescent sign
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound assessmentDiagnostic test
Determination of optic nerve sheath diameter (ONSD), optic disc elevation (ODE) and the presence of the crescent sign using bedside ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound assessment | Other | Not described Receives: Diagnostic Test: Ultrasound assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome
The diagnostic value of ONSD, ODE and the crescent sign in increased intracranial pressure
Measured: An average of 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Assessment of ONSD, ODE and the Crescent Sign Using POCUSStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mümin Murat Yazıcı, Recep Tayyip Erdogan University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719842
- Sponsor's protocol ID
- MuratYazıcı
- Status last verified
- Jul 2026
- First submitted
- 12 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not all of it has been determined
Publications
Janitschke D, Stogbauer J, Lattanzi S, Brigo F, Lochner P. B-mode transorbital ultrasonography for the diagnosis of idiopathic intracranial hypertension: an updated systematic review and meta-analysis. Neurol Sci. 2023 Dec;44(12):4313-4322. doi: 10.1007/s10072-023-07016-z. Epub 2023 Aug 21.
PubMed 37599314Lunia V, Kappagantu V, Bhoi SK, Sinha TP, Jamshed N, Kumar A, Ekka M, Mishra PR, Pandey S. Diagnostic Accuracy of Crescent Sign by Ultrasound in Identifying Increased Intracranial Pressure. J Ultrasound Med. 2026 Jul;45(7):1477-1484. doi: 10.1002/jum.70192. Epub 2026 Feb 3.
PubMed 41631636Sahin A, Akilli NB, Koylu R. The test characteristics of ONSD and ODE tests in predicting the prognosis of patients with traumatic brain injury. Am J Emerg Med. 2026 May;103:170-175. doi: 10.1016/j.ajem.2026.02.015. Epub 2026 Feb 12.
PubMed 41720038Tessaro MO, Friedman N, Al-Sani F, Gauthey M, Maguire B, Davis A. Pediatric point-of-care ultrasound of optic disc elevation for increased intracranial pressure: A pilot study. Am J Emerg Med. 2021 Nov;49:18-23. doi: 10.1016/j.ajem.2021.05.051. Epub 2021 May 21.
PubMed 34051397Marmarou A, Anderson RL, Ward JD, et al. Impact of ICP instability and hypotension on outcome in patients with severe head trauma. J Neurosurg 1991; 75:S59-S66.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of ONSD, ODE, and the Crescent Sign on Ultrasound for Identifying Increased Intracranial Pressure: A Multicenter Study
- ClinicalTrials.gov ID
- NCT07719842
- Acronym / sponsor ID
- MuratYazıcı
- Keywords
- POCUS, ONSD, ODE, crescent sign
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 22 Jul 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.
Our aim was to determine the diagnostic accuracy of the ONSD, ODE, and crescent sign, as detected by POCUS, in identifying the clinical and radiological features of increased intracranial pressure.
Detailed description
All participants presenting to the ED with various symptoms and undergoing cranial CT or MRI for the diagnosis of cranial pathologies who do not meet the exclusion criteria will be included in the study. Informed consent will be obtained from all patients prior to the study. For participants included in the study, the presence of ONSD, ODE, and the crescent sign will be assessed using bedside ultrasound, and the diagnostic value of these findings will be evaluated. The bedside ultrasound will form part of the critical area examination in the emergency department; it will incur no cost to the institution and will be performed and assessed by an emergency medicine specialist and their assistant.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound assessment | Other | Diagnostic Test: Ultrasound assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients presenting at the ED with any symptoms, who have undergone a cranial CT or cranial MRI for the diagnosis of cranial pathologies, and who do not meet the exclusion criteria
Key exclusion criteria (6 listed)
- Patients under the age of 18
- Patients who have not undergone a cranial CT or cranial MRI
- Patients with orbital injuries
- Patients in whom ultrasonographic measurements cannot be performed
- Patients brought to ED following a cardiac arrest
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 |
|---|---|---|
| Ultrasound assessmentDetermination of optic nerve sheath diameter (ONSD), optic disc elevation (ODE) and the presence of the crescent sign using bedside ultrasound | Diagnostic test | Ultrasound assessment |
Primary outcome
Primary outcome
Time frame: An average of 8 months
The diagnostic value of ONSD, ODE and the crescent sign in increased intracranial pressure
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 22 Jul 2026.
- Background: PubMed 37599314Janitschke D, Stogbauer J, Lattanzi S, Brigo F, Lochner P. B-mode transorbital ultrasonography for the diagnosis of idiopathic intracranial hypertension: an updated systematic review and meta-analysis. Neurol Sci. 2023 Dec;44(12):4313-4322. doi: 10.1007/s10072-023-07016-z. Epub 2023 Aug 21.
- Background: PubMed 41631636Lunia V, Kappagantu V, Bhoi SK, Sinha TP, Jamshed N, Kumar A, Ekka M, Mishra PR, Pandey S. Diagnostic Accuracy of Crescent Sign by Ultrasound in Identifying Increased Intracranial Pressure. J Ultrasound Med. 2026 Jul;45(7):1477-1484. doi: 10.1002/jum.70192. Epub 2026 Feb 3.
- Background: PubMed 41720038Sahin A, Akilli NB, Koylu R. The test characteristics of ONSD and ODE tests in predicting the prognosis of patients with traumatic brain injury. Am J Emerg Med. 2026 May;103:170-175. doi: 10.1016/j.ajem.2026.02.015. Epub 2026 Feb 12.
- Background: PubMed 34051397Tessaro MO, Friedman N, Al-Sani F, Gauthey M, Maguire B, Davis A. Pediatric point-of-care ultrasound of optic disc elevation for increased intracranial pressure: A pilot study. Am J Emerg Med. 2021 Nov;49:18-23. doi: 10.1016/j.ajem.2021.05.051. Epub 2021 May 21.
- BackgroundMarmarou A, Anderson RL, Ward JD, et al. Impact of ICP instability and hypotension on outcome in patients with severe head trauma. J Neurosurg 1991; 75:S59-S66.
- Individual participant dataSharing planned: No. Not all of it has been determined
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound assessment in people with Assessment of ONSD, ODE and the Crescent Sign Using POCUS, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 6 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: opening soon, as of the sponsor's last update on 22 Jul 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 Turkey (Türkiye). 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?
Contact Mümin M Yazici, Specialist (+9005364971612, mmuratyazici53@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome (time frame: An average of 8 months). 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 NCT07719842, which also lists 5 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 22 Jul 2026.