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

Hydrocephalus Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02663947
• Other study ID #: 4-2015-1091
• Status: Withdrawn
• Start date: January 2016
• Est. completion date: January 2017

Study information

• Verified date: January 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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:

• Patients with previous history of shunt operation, ocular disease and ocular surgery

• Patients with anatomical or functional abnormality of optic nerve

• emergency patient

Related Conditions & MeSH terms

• Hydrocephalus

Intervention

Device:
• ultrasonographic 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.

Locations

Country	Name	City	State
Korea, Republic of	Associate Professor Department of Anesthesiology and Pain Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ultrasonographic measurement of optic nerve sheath diameter		30 minutes