NCT06492681

Brief Summary

The ultrasound of the optic nerve sheath diameter (ONSD) is a non-invasive tool used in the detection of intracranial hypertension and other neurological conditions. The aim of this research is to evaluate the correlation between the ultrasound measurement of the optic nerve sheath diameter and the side of neurological focus in the physical examination of adult patients evaluated in emergency departments.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 1, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 9, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

12 months

First QC Date

July 1, 2024

Last Update Submit

September 13, 2025

Conditions

Keywords

optic nerve sheath diameterstrokeemergency department

Outcome Measures

Primary Outcomes (1)

  • Correlation between optic nerve sheath and side of clinical neurological focalization

    Estimate the correlation between the ultrasound measurement of the optic nerve sheath diameter and the side of neurological focus in the physical examination of adult patients evaluated in emergency departments.

    In the first 4 hours of arrival to Emergency Department

Secondary Outcomes (1)

  • sensitivity and specificity of the ultrasound measurement of the optic nerve sheath diameter for predicting the side of neurological focus.

    In the first 4 hours of arrival to Emergency Department

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study aims to include a diverse adult population, encompassing various ages, genders, and ethnic backgrounds, reflective of the general demographic seen in emergency departments with suspected ischemic stroke. By doing so, the study seeks to enhance the generalizability of its findings across different subgroups within the adult population.

You may qualify if:

  • Patients with suspected acute ischemic stroke
  • CT scan negative to hemorrhagic stroke
  • Informed consent

You may not qualify if:

  • Contraindications to perform ocular ultrasound
  • Patients with ocular surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Mexico

Piedras Negras, Coahuila, 26020, Mexico

Location

Related Publications (5)

  • Lau T, Ahn JS, Manji R, Kim DJ. A Narrative Review of Point of Care Ultrasound Assessment of the Optic Nerve in Emergency Medicine. Life (Basel). 2023 Feb 15;13(2):531. doi: 10.3390/life13020531.

    PMID: 36836888BACKGROUND
  • Nathani A, Ghamande SA, Kambhampati S, Anderson B, Lohse M, White HD. The Use of POCUS-Obtained Optic Nerve Sheath Diameter in Intracerebral Hemorrhage. POCUS J. 2023 Nov 27;8(2):170-174. doi: 10.24908/pocus.v8i2.16563. eCollection 2023.

    PMID: 38099170BACKGROUND
  • Rajajee V, Vanaman M, Fletcher JJ, Jacobs TL. Optic nerve ultrasound for the detection of raised intracranial pressure. Neurocrit Care. 2011 Dec;15(3):506-15. doi: 10.1007/s12028-011-9606-8.

    PMID: 21769456BACKGROUND
  • Bauerle J, Lochner P, Kaps M, Nedelmann M. Intra- and interobsever reliability of sonographic assessment of the optic nerve sheath diameter in healthy adults. J Neuroimaging. 2012 Jan;22(1):42-5. doi: 10.1111/j.1552-6569.2010.00546.x. Epub 2010 Dec 1.

    PMID: 21121998BACKGROUND
  • Kimberly HH, Shah S, Marill K, Noble V. Correlation of optic nerve sheath diameter with direct measurement of intracranial pressure. Acad Emerg Med. 2008 Feb;15(2):201-4. doi: 10.1111/j.1553-2712.2007.00031.x.

    PMID: 18275454BACKGROUND

MeSH Terms

Conditions

Ischemic StrokeStrokeEmergencies

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Research and Critical Care Medicine

Study Record Dates

First Submitted

July 1, 2024

First Posted

July 9, 2024

Study Start

September 1, 2024

Primary Completion

August 30, 2025

Study Completion

September 1, 2025

Last Updated

September 16, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations