Diagnostic Accuracy of ONSD, ODE, and the Crescent Sign
1 other identifier
interventional
10
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2026
CompletedFirst Posted
Study publicly available on registry
July 22, 2026
CompletedStudy Start
First participant enrolled
August 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2027
July 22, 2026
July 1, 2026
5 months
July 12, 2026
July 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary outcome
The diagnostic value of ONSD, ODE and the crescent sign in increased intracranial pressure
An average of 8 months
Study Arms (1)
Ultrasound assessment
OTHERInterventions
Determination of optic nerve sheath diameter (ONSD), optic disc elevation (ODE) and the presence of the crescent sign using bedside ultrasound
Eligibility Criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Recep Tayyip Erdoğan University Rize Training and Research Hospital
Rize, Centrale, 53020, Turkey (Türkiye)
Related Publications (5)
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.
PMID: 37599314BACKGROUNDLunia 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.
PMID: 41631636BACKGROUNDSahin 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.
PMID: 41720038BACKGROUNDTessaro 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.
PMID: 34051397BACKGROUNDMarmarou 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.
BACKGROUND
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Emergency medicine specialist
Study Record Dates
First Submitted
July 12, 2026
First Posted
July 22, 2026
Study Start
August 1, 2026
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
January 31, 2027
Last Updated
July 22, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share
Not all of it has been determined