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Not yet recruitingNCT07719842Updated Jul 22, 2026

Diagnostic Accuracy of ONSD, ODE, and the Crescent Sign

An interventional study of Ultrasound assessment in Assessment of ONSD, ODE and the Crescent Sign Using POCUS, sponsored by Recep Tayyip Erdogan University Training and Research Hospital. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.

Sponsored by Recep Tayyip Erdogan University Training and Research Hospital · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Assessment of ONSD, ODE and the Crescent Sign Using POCUS

Keywords

  • POCUS
  • ONSD
  • ODE
  • crescent sign
03

In context

Lead sponsor

Recep Tayyip Erdogan University Training and Research Hospital is the lead sponsor of 85 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Other
    Ultrasound assessment

    Diagnostic Test: Ultrasound assessment

Interventions

  • Diagnostic testUltrasound assessment

    Determination of optic nerve sheath diameter (ONSD), optic disc elevation (ODE) and the presence of the crescent sign using bedside ultrasound

06

What researchers measure

Primary outcomes

  1. Primary outcome

    The diagnostic value of ONSD, ODE and the crescent sign in increased intracranial pressure

    Time frame: An average of 8 months

07

Study locations

1 site
  • Recep Tayyip Erdoğan University Rize Training and Research Hospital
    Rize, Centrale 53020, Turkey (Türkiye)
08

References and documents

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 37599314 ↗
  • Lunia 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 41631636 ↗
  • Sahin 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 41720038 ↗
  • Tessaro 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 34051397 ↗
  • Marmarou 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 data

Plan to share: No — Not all of it has been determined

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07719842
Lead sponsor
Recep Tayyip Erdogan University Training and Research Hospital
Responsible party
Mümin Murat Yazıcı (Emergency medicine specialist, Recep Tayyip Erdogan University Training and Research Hospital) — Principal investigator
First posted
Jul 22, 2026
Start date
Aug 1, 2026 (estimated)
Primary completion
Dec 31, 2026 (estimated)
Completion
Jan 31, 2027 (estimated)
Last update
Jul 22, 2026

Study contacts

Mümin M Yazici, Specialist
Contact
mmuratyazici53@gmail.com
+9005364971612

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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