WithdrawnNCT02663947Updated Jan 17, 2019

Comparison of Optic Nerve Sheath Diameter Measured by Ultrasonography Before and After Ventriculoperitoneal Shunt Surgery in Adult Patients With Hydrocephalus

An observational study in Hydrocephalus, sponsored by Yonsei University. Withdrawn at 1 site in Korea, Republic of. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-01-17.

Sponsored by Yonsei University · Observational

Why this study was withdrawn

Because the investigator's workplace and department have been changed, this study cannot be carried out.

Study type: Observational
Model: Case-only
Time perspective: Prospective
Enrollment: 0
Ages: 20 Years to 90 Years
Sex: All

Study summary

Hydrocephalus is a disturbance of cerebrospinal fluid production, flow and absorption leading to intracranial hypertension. Assessment of the change in intracranial pressure after ventriculoperitoneal shunt surgery is important in guiding appropriate postoperative management. The optic nerve sheath diameter measured using ultrasonography has been verified as a non-invasive indicator of intracranial hypertension in various clinical studies. The investigators hypothesized that a change in optic nerve sheath diameter detected through ultrasonography could help ascertain a reduction in intracranial pressure following ventriculoperitoneal shunt surgery in adult patients without the risk of serious complications.

Conditions studied

Hydrocephalus

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Hydrocephalus 210

Keywords

ventriculoperitoneal shunt
optic nerve sheath diameter
intracranial pressure

In context

Hydrocephalus

210 studies on the registry are indexed under Hydrocephalus; 51 are open to participants now.

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Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 90 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Patients who are scheduled for elective ventriculoperitoneal shunt surgery under general anesthesia

Inclusion criteria

Adult patients (20-90 years of age, ASA physical status 3 or less) who are scheduled for elective ventriculoperitoneal shunt surgery with non-communicating hydrocephalus and communicating hydrocephalus except for normal-pressure hydrocephalus
Non-communicating hydrocephalus is defined as a pattern of ventricular system or at the level of the fourth ventricle's outlets by lesions including tumor, giant aneurysm, or aqueductal stenosis.
Communicating hydrocephalus is defined as paraventricular enlargement resulting from postoperative complication after cranial surgery, meningitis, subarachnoid or intracerebral hemorrhage.

Exclusion criteria

Exclusion Criteria:

Patients with previous history of shunt operation, ocular disease and ocular surgery
Patients with anatomical or functional abnormality of optic nerve
emergency patient

Study design

Observational model: Case-only
Time perspective: Prospective
Enrollment: 0 participants (actual)
Patient registry: No

Groups and cohorts

ultrasound group
ultrasonographic measure for optic nerve sheath diameter
Device: ultrasonographic measurement of optic nerve sheath diameter

Interventions

Deviceultrasonographic measurement of optic nerve sheath diameter
A thick layer of gel is applied on the upper closed eyelid. The linear 7.5-MHz ultrasound probe is then placed in the gel, without exerting pressure on the eye. Three measurements are taken for each optic nerve in the transverse plane, with the probe being horizontal. The final ONSD is the mean of these measurements.

What researchers measure

Primary outcomes

ultrasonographic measurement of optic nerve sheath diameter
Time frame: 30 minutes

Study locations

1 site

Associate Professor Department of Anesthesiology and Pain Medicine
Seoul, 120-752, Korea, Republic of

References and documents

Publications

Dubost C, Le Gouez A, Jouffroy V, Roger-Christoph S, Benhamou D, Mercier FJ, Geeraerts T. Optic nerve sheath diameter used as ultrasonographic assessment of the incidence of raised intracranial pressure in preeclampsia: a pilot study. Anesthesiology. 2012 May;116(5):1066-71. doi: 10.1097/ALN.0b013e318246ea1a. PubMed 22258019 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02663947
Lead sponsor: Yonsei University
Responsible party: Sponsor
First posted: Jan 26, 2016
Start date: Jan 2016
Primary completion: Nov 2016 (estimated)
Completion: Jan 2017 (estimated)
Last update: Jan 17, 2019

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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