Study of Ultrasound of the Eye for Children With Suspected Shunt Failure

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Brief Title

Study of Ultrasound of the Eye for Children With Suspected Shunt Failure

Official Title

Pediatric Ocular Ultrasound for VPS Failure

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.
    

Detailed Description

      Children (6 months to 18 years old) with ventriculoperitoneal shunts presenting to the
      Emergency Department (ED) with signs and symptoms of shunt failure will be recruited through
      their parent/legal guardian when the parent/guardian brings the child to the emergency room.
      Ventriculoperitoneal shunt is a device implanted surgically to relieve pressure inside the
      skull (intracranial pressure) caused by water on the brain (hydrocephalus).

      Screening for the study includes a check of the child's age and the diagnosis by CRISP
      volunteer research assistants in the ED between 08:00 and 23:00. If the child is eligible,
      the CRISP volunteer research assistants will contact the study team. Parents/guardians will
      be informed by the study team of the availability of the study and will be asked if they
      would like to have the study explained to them and if they would like to read the consent
      form regarding the study. In addition to that, assent of children over 7 years of age will be
      obtained.

      Information will be collected from the child's medical record, including medical history and
      current and prior symptoms and illnesses. The parent/guardian will also be asked if they
      believe their child's illness is due to a shunt malfunction. The child will undergo a
      physical exam and an ultrasound of the eye where the diameter of their optic nerve (ONSD)
      will be recorded. The optic nerve is the nerve that carries visual messages from the retina
      to the brain. Standard radiographic images, obtained as part of standard of care, will be
      reviewed by study radiologists blinded to the ultrasound results. The study radiologist will
      review the radiologic imaging and record if the outcome is suggestive of shunt failure.
      Another study radiologist from the Casey Eye Institute will review the results of the ocular
      ultrasound and record if the results are optimal or not optimal. Four weeks after the child
      was originally taken to the emergency room, the study team will review the child's medical
      record for information about the child's ED diagnosis, the procedures performed during their
      ED visit and if the initial radiology read was suggestive of shunt failure.

      The study team will complete the ED Encounter Form on the day of the child's visit to the ED.
      The ED Encounter Form includes one question to the parent/guardian, who will be asked if they
      believe their child's illness is due to a shunt malfunction.

      Results will be presented using descriptive statistics. The primary outcome measure is the
      proportion of children with a shunt failure who are correctly identified by the ocular
      ultrasound and proportion of children without shunt failure who have had a negative screening
      test result when an ocular ultrasound is used.
    


Study Type

Observational


Primary Outcome

Optic Nerve Sheath Diameter

Secondary Outcome

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

Condition

Hydrocephalus

Intervention

Ocular Ultrasound

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

36

Start Date

August 2008

Completion Date

March 2009

Primary Completion Date

February 2009

Eligibility Criteria

        Inclusion Criteria:

          -  6 months to 18 years with VPS

          -  Headache

          -  Vomiting

          -  Mental status changes

        Exclusion Criteria:

          -  Elevated intra-ocular pressure or known globe injury
      

Gender

All

Ages

6 Months - 18 Years

Accepts Healthy Volunteers

No

Contacts

Garth D Meckler, MD, MSHS, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00743457

Organization ID

IRB00004484


Responsible Party

Principal Investigator

Study Sponsor

Oregon Health and Science University


Study Sponsor

Garth D Meckler, MD, MSHS, Principal Investigator, Oregon Health and Science University


Verification Date

October 2012