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Optic Nerve Sheath Diameter for Prediction of Sepsis Associated Encephalopathy

NCT05849831 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 89

Last updated 2024-06-04

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Ultrasound measurement of Optic nerve sheath diameter

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.

Sponsors & Collaborators

  • Zagazig University

    lead OTHER_GOV

Principal Investigators

  • Sherif MS Mowafy, MD · Anaesthesia, Intensive Care, and Pain Management Department. Faculty of Medicine, Zagazig University,

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-03
Primary Completion
2024-05-30
Completion
2024-05-30

Countries

  • Egypt

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05849831 on ClinicalTrials.gov