NCT01865149

Brief Summary

Studies in patients with intracranial hypertension have shown a good relationship between optic nerve sheath diameter measured by retrobulbar ultrasound and invasively measured intracranial pressure. The aim of this study was to evaluate changes in optic nerve sheath diameter before and after drainage of cerebrospinal fluid in patients with hydrocephalus.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 30, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

May 30, 2013

Status Verified

May 1, 2013

Enrollment Period

1 year

First QC Date

May 22, 2013

Last Update Submit

May 26, 2013

Conditions

Hydrocephalus

Keywords

ChildOptic nerve sheath diameterHydrocephalusIntracranial hypertension

Outcome Measures

Primary Outcomes (1)

  • both optic nerve sheath diameter (the posterior 3mm of the papilla)

    For day 1 from induction of general anesthesia to average 15 min after recovery of general anesthesia

Study Arms (1)

both optic nerve sheath diameter

Procedure: retrobulbar ultrasound

Interventions

retrobulbar ultrasoundPROCEDURE

both optic nerve sheath diameter (the posterior 3mm of the papilla), 5 individual measurement

both optic nerve sheath diameter

Eligibility Criteria

Age1 Year - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

patient with hydrocephalus

You may qualify if:

  • ASA Ⅰ-Ⅱ
  • aged between 1 and 19 year
  • hydrocephalus
  • general anesthesia for undergoing drainage of cerebrospinal fluid

You may not qualify if:

  • \. an anatomical or functional abnormality in optic nerve

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute,

Seoul, Seoul, 120-752, South Korea

RECRUITING

MeSH Terms

Conditions

HydrocephalusIntracranial Hypertension

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Hyunzu Kim, MD

CONTACT

82-2-2228-2422aneshyunzu@yuhs.ac

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2013

First Posted

May 30, 2013

Study Start

May 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

May 30, 2013

Record last verified: 2013-05

Locations

KR(1)