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

NCT02663947 | Withdrawn

• 1 other identifier: 4-2015-1091
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Hydrocephalus

Keywords

ventriculoperitoneal shunt; optic nerve sheath diameter; intracranial pressure

Outcome Measures

Primary Outcomes (1)

• ultrasonographic measurement of optic nerve sheath diameter

  30 minutes

Study Arms (1)

ultrasound group

ultrasonographic measure for optic nerve sheath diameter

Device: ultrasonographic measurement of optic nerve sheath diameter

Interventions

ultrasonographic measurement of optic nerve sheath diameter DEVICE

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.

ultrasound group

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Associate Professor Department of Anesthesiology and Pain Medicine

Seoul, 120-752, South Korea

Location

Related 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.

  PMID: 22258019 BACKGROUND

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2016
• First Posted: January 26, 2016
• Study Start: January 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: January 1, 2017
• Last Updated: January 17, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)