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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Garth Meckler, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00743457
First received: August 27, 2008
Last updated: October 12, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Hydrocephalus
Device: Ocular Ultrasound

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pediatric Ocular Ultrasound for VPS Failure

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Optic Nerve Sheath Diameter [ Time Frame: Within 4 hours of enrollment ] [ Designated as safety issue: No ]
  • Clinical VPS Failure [ Time Frame: Within 4 weeks of enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Standard Neuro-imaging Results (CT, MRI, X-rays) [ Time Frame: Day of enrollment ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: August 2008
Study Completion Date: March 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
VPS Patients
Children 6 months-18 years with VPS and symptoms of possible shunt failure
Device: Ocular Ultrasound
B-mode ultrasound of the eye with 90 and 30 degree view of optic nerve sheath

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.

  Eligibility

Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00743457

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239-3098
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Garth D Meckler, MD, MSHS Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Garth Meckler, Associate Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00743457     History of Changes
Other Study ID Numbers: IRB00004484
Study First Received: August 27, 2008
Last Updated: October 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Possible VPS failure with symptom such as headache
vomiting
lethargy
VPS failure

Additional relevant MeSH terms:
Hydrocephalus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Intracranial Hypertension

ClinicalTrials.gov processed this record on August 18, 2014