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

Recruiting

• Conditions: Ischemic Stroke

• Registration Number: NCT06492681
• Lead Sponsor: Clinica Mexico

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.

Detailed Description

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:

1. Informed consent will be obtained from patients who meet the inclusion criteria.

2. A neurological physical examination will be performed to identify the side of neurological focus.

3. The optic nerve sheath diameter will be measured using ultrasound with a high-frequency linear transducer (7.5-12 MHz).

4. 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.

Study Timeline

• Study First Submitted: 2024-07-01
• Study First Submitted QC: 2024-07-01
• Study First Posted: 2024-07-09
• Study Start: 2024-09-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-17
• Primary Completion: 2025-08-30
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between optic nerve sheath and side of clinical neurological focalization	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 Outcome Measures

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

Trial Locations

Locations (1)

Clinica Mexico; 🇲🇽 Piedras Negras, Coahuila, Mexico