Ignite Creation Date:
2024-07-17 @ 10:51 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492681
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-07-01
Brief Title:
Correlation Between Optic Nerve Sheath Diameter and Neurological Deficit in Adult Patients With Suspected Ischemic Stroke
Sponsor:
Clinica Mexico
Organization:
Clinica Mexico
Study Overview
Official 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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 75-12 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 Pearsons or Spearmans 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 hospitals Research Ethics Committee before its implementation
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 75-12 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 Pearsons or Spearmans 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 hospitals Research Ethics Committee before its implementation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None