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Completed

NCT Number: NCT02776085

Bedside Ultrasound to Measure Optic Nerve Sheath Diameter in Pediatric CSF Shunts

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.

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Key information

Age range

6 month–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Compare the initial and final optic nerve sheath diameters measured by ultrasound in patients who are admitted for shunt failure

    Time frame: 3 days

    Patients will have their ONSD measured by ultrasound in the emergency department or immediately after admission. After they either receive antibiotics or shunt revision surgery, and are no longer symptomatic from shunt failure, their ONSD will be measured again and compared to the initial measurement.

Secondary outcomes

  1. 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.

    Time frame: 6 months

    The ONSD will be measured for all pediatric patients with CSF shunts who come to the emergency department, and then the average measurements of each group will be compared to the other two groups to evaluate if there are significant differences in the measurements.

Other outcomes

  1. Physician Funduscopy Accuracy

    Time frame: 6 months

    The results of physician funduscopy of symptomatic patients will be compared to the imaging done for children to evaluate if physicians can visualize signs of increased intracranial pressure on funduscopic exam.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Using Bedside Ultrasound to Measure the Optic Nerve Sheath Diameter in the Evaluation of Pediatric Patients With CSF Shunts

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
May 18, 2016
Registry last updated
Apr 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.