Cerebrospinal Fluid ShuntsNCT02776085
Bedside Ultrasound to Measure Optic Nerve Sheath Diameter in Pediatric CSF Shunts
An observational study of Cerebrospinal Fluid Shunts, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebrospinal Fluid Shunts
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 17 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolinas Medical Center
Charlotte, North Carolina, 28203
About this study
Official title: Using Bedside Ultrasound to Measure the Optic Nerve Sheath Diameter in the Evaluation of Pediatric Patients With 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.
Read the 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.
- Conditions
- Cerebrospinal Fluid Shunts
- Keywords
- optic nerve sheath diameter, ultrasound, shunt failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study startMay 2016
- Primary completionJan 2018
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrospinal Fluid ShuntsStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christyn Magill, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02776085
- Sponsor's protocol ID
- ONSD
- Status last verified
- Jan 2019
- First submitted
- 16 May 2016
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Bedside Ultrasound to Measure the Optic Nerve Sheath Diameter in the Evaluation of Pediatric Patients With CSF Shunts
- ClinicalTrials.gov ID
- NCT02776085
- Acronym / sponsor ID
- ONSD
- Conditions
- Cerebrospinal Fluid Shunts
- Keywords
- optic nerve sheath diameter, ultrasound, shunt failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 18 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christyn Magill, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrospinal Fluid Shunts, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the initial and final optic nerve sheath diameters measured by ultrasound in patients who are admitted for shunt failure (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022; AzTrials last refreshed its copy on 7 Nov 2026.