Optic Nerve Sheath Diameter: A Non-Invasive Indicator of Intracranial Pressure in the Intensive Care Unit Monitoring

Not Applicable

Completed

• Conditions: Intracranial Hypertension; ICP (Intracranial Pressure) Increase; Optic Nerve Sheath Diameter

• Registration Number: NCT06367868
• Lead Sponsor: Istanbul University - Cerrahpasa (IUC)

Brief Summary

Determination of high intracranial pressure (ICP) is necessary for the treatment of patients with raised ICP to improve long-term neurological outcomes. Ultrasonographic optic nerve sheath diameter (ONSD) measurement is a noninvasive, easily performed and cost effective technique for detecting high ICP.

Detailed Description

ICP measurements via ventricular catheters provide CSF drainage and ICP reduction. The normal ICP value is less than 15 mmHg in adults. In the literature the correlation of ONSD and invasive ICP measurements were determined. The aim of study is to evaluate the correlation of ONSD and direct ICP measurements and to determine cut off ONSD value to detect ICP ≥15 mmHg.

Study Timeline

• Study Start: 2021-09-09
• Primary Completion: 2022-06-01
• Study Completion: 2022-12-01
• Status Verified: 2024-04
• Study First Submitted: 2024-04-05
• Study First Submitted QC: 2024-04-13
• Last Update Submitted: 2024-04-13
• Study First Posted: 2024-04-16
• Last Update Posted: 2024-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• 18-80 aged patients
• With an external ventricular drainage catheter due to intracranial pathology

Exclusion Criteria

• Under the age of 18
• Orbital tumors
• Graves' disease
• Exophthalmos
• Sarcoidosis
• Optic neuropathy
• Meningitis
• Ocular trauma
• Lung diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Intracranial Pressure-1 (ICP-1)	baseline time	Measurement of intracranial pressure before cerebrospinal fluid (CSF) drainage
Optic Nerve Sheath Diameter-1 (ONSD-1)	baseline time	Measurement of optic nerve sheath diameter before cerebrospinal fluid drainage

Secondary Outcome Measures

Name	Time	Method
Intracranial Pressure-2 (ICP-2)	2 minutes after CSF drainage	Measurement of intracranial pressure 2 minutes after cerebrospinal fluid (CSF) drainage
Optic Nerve Sheath Diameter-2 (ONSD-2)	2 minutes after CSF drainage	Measurement of optic nerve sheath diameter 2 minutes after cerebrospinal fluid drainage

Trial Locations

Locations (1)

Istanbul University-Cerrahpasa; 🇹🇷 Istanbul, Fatıh, Turkey