Study of Ultrasound of the Eye for Children With Suspected Shunt Failure
Condition: Hydrocephalus
MeSH terms: Hydrocephalus
Study type: Observational

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.
    

Intervention name(s): Ocular Ultrasound
Intervention type(s): Device
Intervention description(s): B-mode ultrasound of the eye with 90 and 30 degree view of optic nerve sheath
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-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
      
Keywords: Possible VPS failure with symptom such as headache; vomiting; lethargy; VPS failure