Diagnostic Accuracy of ONSD, ODE, and the Crescent Sign

July 19, 2026 updated by: Mümin Murat Yazıcı, Recep Tayyip Erdogan University Training and Research Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
    • Centrale
      • Rize, Centrale, Turkey (Türkiye), 53020
        • Recep Tayyip Erdoğan University Rize Training and Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Ultrasound assessment
Diagnostic test: Ultrasound assessment
Determination of optic nerve sheath diameter (ONSD), optic disc elevation (ODE) and the presence of the crescent sign using bedside ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary outcome
Time Frame: An average of 8 months
The diagnostic value of ONSD, ODE and the crescent sign in increased intracranial pressure
An average of 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Recep Tayyip Erdogan University Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

July 12, 2026

First Submitted That Met QC Criteria

July 19, 2026

First Posted (Actual)

July 22, 2026

Study Record Updates

Last Update Posted (Actual)

July 22, 2026

Last Update Submitted That Met QC Criteria

July 19, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MuratYazıcı

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not all of it has been determined

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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