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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Intracranial Hypertension
• Optic Nerve Sheath Diameter

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