Clinical trial NCT06367868: Optic Nerve Sheath Diameter: A Non-Invasive Indicator of Intracranial Pressure in the Intensive Care Unit Monitoring
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ICP (Intracranial Pressure) Increase
Optic Nerve Sheath Diameter
Intracranial Hypertension
Keywords: ONSD
ultrasonography
noninvasive
increased intracranial pressure
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intracranial Pressure-1 (ICP-1)
timeFrame: baseline time
measure: Optic Nerve Sheath Diameter-1 (ONSD-1)
timeFrame: baseline time
Secondary outcomes:
measure: Intracranial Pressure-2 (ICP-2)
timeFrame: 2 minutes after CSF drainage
measure: Optic Nerve Sheath Diameter-2 (ONSD-2)
timeFrame: 2 minutes after CSF drainage
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
state: Fatıh
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: GULSAH ORAK
role: STUDY_DIRECTOR
affiliation: Istanbul University - Cerrahpasa
name: OZLEM KORKMAZ DİLMEN
role: STUDY_CHAIR
affiliation: Istanbul University - Cerrahpasa
name: EREN FATMA AKCİL
role: STUDY_CHAIR
References:
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.
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.
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.
citation: 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.