NCT07719842

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

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
6mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 22, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

July 22, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

July 12, 2026

Last Update Submit

July 19, 2026

Conditions

Keywords

POCUSONSDODEcrescent sign

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

OTHER
Diagnostic Test: Ultrasound assessment

Interventions

Ultrasound assessmentDIAGNOSTIC_TEST

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

Ultrasound assessment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

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: 37599314BACKGROUND
  • 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.

    PMID: 41631636BACKGROUND
  • 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.

    PMID: 41720038BACKGROUND
  • 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.

    PMID: 34051397BACKGROUND
  • 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.

    BACKGROUND

Central Study Contacts

Mümin M Yazici, Specialist

CONTACT

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

Locations