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

NCT02776085 | Completed DMC

• 1 other identifier: ONSD
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrospinal Fluid Shunts

Keywords

optic nerve sheath diameter; ultrasound; shunt failure

Outcome Measures

Primary Outcomes (1)

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

  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.

  3 days

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.

  6 months

Other Outcomes (1)

• Physician Funduscopy Accuracy

  6 months

Study Arms (3)

Asymptomatic

Group of patients with CSF shunts who are evaluated for a reason other than concern for shunt failure. The optic nerve sheath diameter of these patients will be used as baseline measurements for children with CSF shunts.

Symptomatic, Not Admitted

Group of patients with CSF shunts who are evaluated for concerns of shunt malfunction or failure, but either have shunt failure ruled out, or are felt to be safe for discharge to home. They are not admitted to the hospital. The optic nerve sheath diameter of these patients will be measured once in the emergency department.

Symptomatic, Admitted

Group of patients with CSF shunts who are evaluated for concerns of shunt malfunction or failure, and then are admitted to the hospital secondary to these concerns. The optic nerve sheath diameter of these patients will be measured once in the emergency department or as close to admission as possible, and then measured again while they are still inpatient, but after they have an intervention performed (medical or surgical) to relieve their shunt malfunction or failure. These patients will have their initial optic nerve sheath diameters compared to the other two populations, but they will also have their initial and final optic nerve sheath diameters compared to each other.

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Study Officials

• Christyn Magill, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2016
• First Posted: May 18, 2016
• Study Start: May 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2019
• Last Updated: April 28, 2022

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)