CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 89 enrolled
Drug / intervention
Ultrasound measurement of Optic nerve sheath diameterother
Likely dose
Not stated in record
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Search/NCT05849831
NCT05849831N/ACompleted

The Role of Ultrasonographic Assessment of Optic Nerve Sheath Diameter in Prediction of Sepsis Associated Encephalopathy

Zagazig University·observational·Posted May 9, 2023·Updated Jun 4, 2024

In Brief

An observational study evaluating Ultrasound measurement of Optic nerve sheath diameter for Sepsis. Completed, enrolled 89 participants across 2 sites.

Detailed Summary

Sepsis-associated brain dysfunction (SABD)with increased intracranial pressure is a complex pathology that can lead to unfavourable outcome. Although direct measurement of intracranial pressure using an intra-ventricular catheter remains the gold standard, it is burdened with potential serious complications due to its invasiveness. Ultrasonic measurement of optic nerve sheath diameter (ONSD) is a non-invasive method for ICP monitoring. Screening for SABD is crucial for early diagnosis and management, measurement of ONSD can detect elevated intracranial pressure in septic patients. Intracranial hypertension in septic patients might be a sign of SABD. Using ONSD for SABD screening requires further research. So, we hypothesized that ONSD could be used as an objective screening tool to predict and early diagnose SABD in adult septic patients.

Study Details

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

Timeline

N/ACompletedFinished
202420252026
First PostedMay 9, 2023
Enrollment StartMay 3, 2023
Primary CompletionMay 30, 2024
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 3.1 years ago

Interventions

Ultrasound measurement of Optic nerve sheath diameterother

Ocular ultrasonography will be performed by single skilled examiner with patients placed in supine position with closed eyes. A layer of ultrasound gel will be applied over the closed upper eyelid and the liner high frequency probe 7 - 12 MHz of SonoSite M-Turbo ultrasound machine is placed on temporal area of eyelid with the hand holding it resting on forehead of patient. ONSD is measured 3mm behind the globe in the transverse plane perpendicular to the optic nerve. For each eye one measurement will be made and the reported ONSD corresponds to the mean of the two values obtained for each patient. An average ONSD greater than 5 mm is considered abnormal and elevated intracranial pressure should be suspected. all enrolled subjects will be eligible for ONSD measurements, SOFA score calculation, as well as GCS assessment on daily basis for up to 10 consecutive days, until ICU discharge or death.