Clinical Trial: Study of Ultrasound of the Eye for Children With Suspected Shunt Failure
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
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 Summary:
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 optima
Sponsor: Oregon Health and Science University
Current Primary Outcome:
- Optic Nerve Sheath Diameter [ Time Frame: Within 4 hours of enrollment ]
- Clinical VPS Failure [ Time Frame: Within 4 weeks of enrollment ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Standard Neuro-imaging Results (CT, MRI, X-rays) [ Time Frame: Day of enrollment ]
Original Secondary Outcome: Same as current
Information By: Oregon Health and Science University
Dates:
Date Received: August 27, 2008
Date Started: August 2008
Date Completion:
Last Updated: October 12, 2012
Last Verified: October 2012
