NCT06367868

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 9, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 16, 2024

Completed
Last Updated

April 16, 2024

Status Verified

April 1, 2024

Enrollment Period

9 months

First QC Date

April 5, 2024

Last Update Submit

April 13, 2024

Conditions

ICP (Intracranial Pressure) IncreaseOptic Nerve Sheath DiameterIntracranial Hypertension

Keywords

ONSDultrasonographynoninvasiveincreased intracranial pressure

Outcome Measures

Primary Outcomes (2)

  • Intracranial Pressure-1 (ICP-1)

    Measurement of intracranial pressure before cerebrospinal fluid (CSF) drainage

    baseline time

  • Optic Nerve Sheath Diameter-1 (ONSD-1)

    Measurement of optic nerve sheath diameter before cerebrospinal fluid drainage

    baseline time

Secondary Outcomes (2)

  • Intracranial Pressure-2 (ICP-2)

    2 minutes after CSF drainage

  • Optic Nerve Sheath Diameter-2 (ONSD-2)

    2 minutes after CSF drainage

Study Arms (1)

Before Drainage

EXPERIMENTAL

Optic nerve sheath diameter and intracranial pressure will be measured before CSF drainage

Procedure: After 5 ml CSF Drainage

Interventions

After 5 ml CSF DrainagePROCEDURE

Optic Nerve Sheath Diameter and Intracranial Pressure measurements will be after 5 ml CSF drainage

Before Drainage

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Fatıh, 34098, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 30019201BACKGROUND

  • 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.

    PMID: 36983213BACKGROUND

  • 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.

    PMID: 32852360BACKGROUND

  • 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.

    PMID: 18275454BACKGROUND

MeSH Terms

Conditions

Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • GULSAH ORAK

    Istanbul University - Cerrahpasa

    STUDY DIRECTOR

  • OZLEM KORKMAZ DİLMEN

    Istanbul University - Cerrahpasa

    STUDY CHAIR

  • EREN FATMA AKCİL

    Istanbul University - Cerrahpasa

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor-Anesthesiology and Reanimation

Study Record Dates

First Submitted

April 5, 2024

First Posted

April 16, 2024

Study Start

September 9, 2021

Primary Completion

June 1, 2022

Study Completion

December 1, 2022

Last Updated

April 16, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)