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NCT06367868 Clinical Trial

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

Intracranial Hypertension Clinical Trial

Official title:
Evaluation of the Effect of Cerebrospinal Fluid Drainage on Optic Nerve Sheath Diameter in Patients Installed External Ventricular Drainage Catheter Due to Intracranial Pathology in the Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06367868
Other study ID # E-83045809-604.01.02-179951
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 9, 2021
Est. completion date December 1, 2022

Study information
Verified date April 2024
Source Istanbul University - Cerrahpasa (IUC)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 44
Est. completion date December 1, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• After 5 ml CSF Drainage
Optic Nerve Sheath Diameter and Intracranial Pressure measurements will be after 5 ml CSF drainage

Locations
Country Name City State
Turkey Istanbul University-Cerrahpasa Istanbul Fatih

Sponsors (1)
Lead Sponsor Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Kimberly HH, Shah S, Marill K, Noble V. Correlation of optic nerve sheath diameter with direct measurement of intracranial pressure. Acad Emerg Med. 2008 Feb;15(2):201-4. doi: 10.1111/j.1553-2712.2007.00031.x. — View Citation

Muller SJ, Henkes E, Gounis MJ, Felber S, Ganslandt O, Henkes H. Non-Invasive Intracranial Pressure Monitoring. J Clin Med. 2023 Mar 13;12(6):2209. doi: 10.3390/jcm12062209. — View Citation

Robba C, Santori G, Czosnyka M, Corradi F, Bragazzi N, Padayachy L, Taccone FS, Citerio G. Optic nerve sheath diameter measured sonographically as non-invasive estimator of intracranial pressure: a systematic review and meta-analysis. Intensive Care Med. 2018 Aug;44(8):1284-1294. doi: 10.1007/s00134-018-5305-7. Epub 2018 Jul 17. — View Citation

Sharawat IK, Kasinathan A, Bansal A, Sahu JK, Sodhi KS, Dogra MR, Sankhyan N. Evaluation of Optic Nerve Sheath Diameter and Transcranial Doppler As Noninvasive Tools to Detect Raised Intracranial Pressure in Children. Pediatr Crit Care Med. 2020 Nov;21(11):959-965. doi: 10.1097/PCC.0000000000002523. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Intracranial Pressure-1 (ICP-1) Measurement of intracranial pressure before cerebrospinal fluid (CSF) drainage baseline time
Primary Optic Nerve Sheath Diameter-1 (ONSD-1) Measurement of optic nerve sheath diameter before cerebrospinal fluid drainage baseline time
Secondary Intracranial Pressure-2 (ICP-2) Measurement of intracranial pressure 2 minutes after cerebrospinal fluid (CSF) drainage 2 minutes after CSF drainage
Secondary Optic Nerve Sheath Diameter-2 (ONSD-2) Measurement of optic nerve sheath diameter 2 minutes after cerebrospinal fluid drainage 2 minutes after CSF drainage
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