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Completed

NCT Number: NCT06492681

Correlation Between Optic Nerve Sheath Diameter and Neurological Deficit in Adult Patients With Suspected Ischemic Stroke

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinica Mexico

Piedras Negras, Coahuila, 26020, Mexico

About this study

II. Hypothesis The ultrasound measurement of the optic nerve sheath diameter correlates with the side of neurological focus in the physical examination of adult patients evaluated in emergency departments.

III. Objectives 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.

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

IV. Methodology

Study design:

A observational study will be conducted in a secondary care hospital.

Population and sample:

Adult patients (≥18 years) presenting to the emergency department with neurological symptoms, such as headache, altered level of consciousness, motor or sensory deficit, among others, will be included. Patients with contraindications for ocular ultrasound or with a history of previous ocular surgery will be excluded.

Procedures:

  • Informed consent will be obtained from patients who meet the inclusion criteria.
  • A neurological physical examination will be performed to identify the side of neurological focus.
  • The optic nerve sheath diameter will be measured using ultrasound with a high-frequency linear transducer (7.5-12 MHz).
  • Demographic, clinical, and ultrasound data will be recorded for the patients.

Data analysis:

The correlation between the ultrasound measurement of the optic nerve sheath diameter and the side of neurological focus will be calculated using Pearson's or Spearman's correlation coefficient, depending on the distribution of the data. Additionally, sensitivity, specificity, positive and negative predictive values, and 95% confidence intervals will be calculated to determine the diagnostic utility of the ultrasound measurement of the optic nerve sheath diameter in identifying the side of neurological focus.

V. Ethical considerations The ethical guidelines established by the Declaration of Helsinki will be followed, and the privacy and confidentiality of patients will be protected. The protocol will be approved by the hospital's Research Ethics Committee before its implementation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Contraindications to perform ocular ultrasound
  • Patients with ocular surgery

Treatment and study plan

Primary outcomes

  1. Correlation between optic nerve sheath and side of clinical neurological focalization

    Time frame: In the first 4 hours of arrival to Emergency Department

    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.

Secondary outcomes

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

    Time frame: In the first 4 hours of arrival to Emergency Department

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

Sponsors and collaborators

Lead sponsor

Clinica Mexico

Other

Registry information

Official study title

Correlation Between Optic Nerve Sheath Diameter Measured by POCUS and Neurological Deficit in Physical Examination in Adult Patients With Suspected Ischemic Stroke Evaluated in Emergency Departments

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 9, 2024
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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