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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02663947
Other study ID # 4-2015-1091
Secondary ID
Status Withdrawn
Phase
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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
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