Clinical trial NCT02776085: Bedside Ultrasound to Measure Optic Nerve Sheath Diameter in Pediatric CSF Shunts
Official title: Using Bedside Ultrasound to Measure the Optic Nerve Sheath Diameter in the Evaluation of Pediatric Patients With CSF Shunts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebrospinal Fluid Shunts
Keywords: optic nerve sheath diameter
ultrasound
shunt failure
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2016-05-18
Enrollment: 64
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients with cerebrospinal fluid shunts who are evaluated in the emergency department for any reason, or are admitted to the hospital through the neurosurgery clinic.

Brief summary: Bedside ultrasound in the emergency department is useful for quick assessments of patients. One growing use is to measure the optic nerve sheath diameter of patients for whom increased pressure in the head is a concern. This study will look at the optic nerve sheath diameters of a specific population of pediatric patients with shunts that drain extra fluid from their heads.

Detailed description: The particular interest of this study is the use of ultrasound to evaluate a child's optic nerve sheath diameter (ONSD), or the size of the covering around the nerve behind the eye. This covering expands when there is a higher than normal pressure inside the head. The group of interest on which this study focuses is the children with cerebrospinal shunts that drain extra fluid from their heads to other parts of the body (abdomen, heart, lungs) because the brain cannot drain all of the fluid like normal. When these shunts malfunction or fail, this can cause a backup of fluid in the brain, and raise the intracranial pressure (ICP) inside the skull. Depending on the degree of pressure buildup, this can be a surgical emergency due to pressure on the brain. Currently, computed tomography (CT) scans or magnetic resonance imaging (MRI) scans are used to diagnose the condition, but a quick screening tool, such as use of ultrasound to screen for elevated ICP in the emergency department, would be of great benefit to the patients to expedite care. Previous studies have explored the use of bedside ultrasound to evaluate the optic nerve sheath diameter in children with shunts. However, to date, there have been no reported prospective observational studies that compared before and after ultrasound measurements of the ONSD in patients in whom shunt failure is diagnosed and treated. Of note, this study is observational and the measurements taken with the ultrasound machine will not be used for clinical decision making. The measurements in this study will have no clinical impact on patient care. The use of ultrasound to measure the ONSD is an already accepted application of ultrasound.

Eligibility criteria: Inclusion Criteria:

* Children and adolescents, ages 6 months through 17 years who have a shunt and who present to the children's emergency department for evaluation and treatment.
* Children and adolescents, ages 6 months through 17 years who have a shunt and are directly admitted to the inpatient children's hospital from an outside facility.

Exclusion Criteria:

* Patients for whom the parents or guardians do not agree to participate in the study.
* Patients with any acute trauma to the eyes, face, or head.
* Severe anaphylactic allergy to ultrasound gel or Tegaderm

Primary outcomes:
measure: Compare the initial and final optic nerve sheath diameters measured by ultrasound in patients who are admitted for shunt failure
timeFrame: 3 days
Secondary outcomes:
measure: Compare the optic nerve sheath diameter measurements of asymptomatic patients vs symptomatic patients who are not diagnosed with shunt failure vs those are diagnosed with shunt failure and admitted.
timeFrame: 6 months
Other outcomes:
measure: Physician Funduscopy Accuracy
timeFrame: 6 months
Locations:
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Christyn Magill, MD
role: PRINCIPAL_INVESTIGATOR
References: