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Clinical Trials/NCT06492681
NCT06492681
Completed
Not Applicable

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

Clinica Mexico1 site in 1 country19 target enrollmentSeptember 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Clinica Mexico
Enrollment
19
Locations
1
Primary Endpoint
Correlation between optic nerve sheath and side of clinical neurological focalization
Status
Completed
Last Updated
7 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2024
End Date
September 1, 2025
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Clinica Mexico
Responsible Party
Principal Investigator
Principal Investigator

Jose Ivan Rodriguez de Molina Serrano

Head of Research and Critical Care Medicine

Clinica Mexico

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • 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)

Study Sites (1)

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