CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 89 enrolled
Drug / intervention
Ultrasound optic nerve sheath diameter / eyeball transverse diameter ratioprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05918705
NCT05918705N/ACompleted

Is the Ratio of Optic Nerve Sheath Diameter to Eyeball Transverse Diameter Correlated with the Prognosis of Sepsis Associated Encephalopathy in Critically Ill Patients

Zagazig University·observational·Posted Jun 26, 2023·Updated Aug 30, 2024

In Brief

An observational study evaluating Ultrasound optic nerve sheath diameter / eyeball transverse diameter ratio for Sepsis-associated Encephalopathy. Completed, enrolled 89 participants across 1 site.

Detailed Summary

Sepsis is associated with a mortality rate of 20-25%, with significant increase in case of associated comorbidities or shock. SAE is one of the most common forms of encephalopathy encountered in critically ill patients, with increased ICP as a possible underlying mechanism. Many studies revealed that ONSD is a valuable ICP monitoring tool. Also, ONSD/ETD ratio, according to previous studies, seemed to be more reliable than ONSD alone in predicting neurological outcomes of comatosed patients. The present study will assess the correlation between US-ONSD/ETD ratio and the prognosis of SAE in critically ill patients.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesEgypt
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedJun 26, 2023
Enrollment StartMar 1, 2023
Primary CompletionAug 1, 2024
Study CompletionAug 10, 2024
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 3.0 years ago

Interventions

Ultrasound optic nerve sheath diameter / eyeball transverse diameter ratioprocedure

Ocular ultrasonography will be performed once daily on patients diagnosed with sepsis associated encephalopathy at the bedside by two experienced examiners, who will be blinded to patients' clinical data, following the CLOSED protocol for ONSD sonography. ONSD will be measured at 3 mm behind the merging point of the nerve from the papilla "optic disc". The maximum external diameter of ONSD will be measured in the transverse plane perpendicular to the optic nerve and the maximum diameter of ETD (parallel lens) on this plane will be measured. Two measurements will be taken for each eye; horizontal and vertical. The sequence for measurements will be left eye horizontal; left eye vertical; right eye horizontal; right eye vertical. The ONSD measurements in the transversal and the sagittal plane for each eye measured by the two examiners will be averaged. Then, ETDs measurements will be averaged to obtain averaged ONSD/ETD ratio as a data to record the mean values of ONSD/ETD ratio.