HydrocephalusNCT00743457
Study of Ultrasound of the Eye for Children With Suspected Shunt Failure
An observational study of Hydrocephalus, run by Oregon Health and Science University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Hydrocephalus
- What is being tested?
- Ocular Ultrasound
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Mar 2009
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients 6 months to 18 years of age with VPS and symptoms of potential shunt failure presenting the the emergency department
Who may be able to join
- 6 months to 18 years with VPS
- Headache
- Vomiting
- Mental status changes
Who cannot join
- Elevated intra-ocular pressure or known globe injury
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239-3098
About this study
Official title: Pediatric Ocular Ultrasound for VPS Failure
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.
Read the 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.
- Conditions
- Hydrocephalus
- Being tested
- Ocular Ultrasound
- Keywords
- Possible VPS failure with symptom such as headache, vomiting, lethargy, VPS failure
- Medical subject headings
- Hydrocephalus, Vomiting, Lethargy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ocular UltrasoundDevice
B-mode ultrasound of the eye with 90 and 30 degree view of optic nerve sheath
| Study group | Role | What they receive |
|---|---|---|
| VPS Patients | Children 6 months-18 years with VPS and symptoms of possible shunt failure Receives: Device: Ocular Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic Nerve Sheath Diameter
Measured: Within 4 hours of enrollment
Clinical VPS Failure
Measured: Within 4 weeks of enrollment
Secondary outcomes (1)
Standard Neuro-imaging Results (CT, MRI, X-rays)
Measured: Day of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionFeb 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrocephalusStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Garth Meckler, Oregon Health and Science University
- Investigators
- Garth D Meckler, MD, MSHS, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00743457
- Sponsor's protocol ID
- IRB00004484
- Status last verified
- Oct 2012
- First submitted
- 27 Aug 2008
- Last updated
- 15 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Ocular Ultrasound for VPS Failure
- ClinicalTrials.gov ID
- NCT00743457
- Acronym / sponsor ID
- IRB00004484
- Conditions
- Hydrocephalus
- Keywords
- Possible VPS failure with symptom such as headache, vomiting, lethargy, VPS failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 28 Aug 2008 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VPS Patients | – | Device: Ocular UltrasoundChildren 6 months-18 years with VPS and symptoms of possible shunt failure |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients 6 months to 18 years of age with VPS and symptoms of potential shunt failure presenting the the emergency department
Key inclusion criteria (4 listed)
- 6 months to 18 years with VPS
- Headache
- Vomiting
- Mental status changes
Key exclusion criteria (1 listed)
- Elevated intra-ocular pressure or known globe injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ocular UltrasoundB-mode ultrasound of the eye with 90 and 30 degree view of optic nerve sheath | Device | VPS Patients |
Primary outcome
Optic Nerve Sheath Diameter
Time frame: Within 4 hours of enrollment
Clinical VPS Failure
Time frame: Within 4 weeks of enrollment
1 secondary outcome
Standard Neuro-imaging Results (CT, MRI, X-rays)
Time frame: Day of enrollment
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 15 Oct 2012.
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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.
Garth D Meckler, MD, MSHS principal investigator
Oregon Health and Science University
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 Hydrocephalus, run by Oregon Health and Science University 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 4 inclusion and 1 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 15 Oct 2012. 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?
Optic Nerve Sheath Diameter (time frame: Within 4 hours of enrollment). The study lists 2 primary outcomes in all. 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 15 Oct 2012.