NCT00743457

Brief Summary

The purpose of the study is to determine whether an ultrasound of the eye can be used as a radiation-free alternative to X-ray to identify children with risk of shunt failure in the Emergency Department. Please note that a shunt is an artificial or natural channel running between two other channels.2. Briefly summarize how participants are recruited.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2008

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 28, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

October 15, 2012

Status Verified

October 1, 2012

Enrollment Period

6 months

First QC Date

August 27, 2008

Last Update Submit

October 12, 2012

Conditions

Hydrocephalus

Keywords

Possible VPS failure with symptom such as headachevomitinglethargyVPS failure

Outcome Measures

Primary Outcomes (2)

  • Optic Nerve Sheath Diameter

    Within 4 hours of enrollment

  • Clinical VPS Failure

    Within 4 weeks of enrollment

Secondary Outcomes (1)

  • Standard Neuro-imaging Results (CT, MRI, X-rays)

    Day of enrollment

Study Arms (1)

VPS Patients

Children 6 months-18 years with VPS and symptoms of possible shunt failure

Device: Ocular Ultrasound

Interventions

Ocular UltrasoundDEVICE

B-mode ultrasound of the eye with 90 and 30 degree view of optic nerve sheath

VPS Patients

Eligibility Criteria

Age6 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients 6 months to 18 years of age with VPS and symptoms of potential shunt failure presenting the the emergency department

You may qualify if:

  • months to 18 years with VPS
  • Headache
  • Vomiting
  • Mental status changes

You may not qualify if:

  • Elevated intra-ocular pressure or known globe injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239-3098, United States

Location

MeSH Terms

Conditions

HydrocephalusVomitingLethargy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsNeurobehavioral ManifestationsNeurologic Manifestations

Study Officials

  • Garth D Meckler, MD, MSHS

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 27, 2008

First Posted

August 28, 2008

Study Start

August 1, 2008

Primary Completion

February 1, 2009

Study Completion

March 1, 2009

Last Updated

October 15, 2012

Record last verified: 2012-10

Locations

US(1)