Intracranial HypertensionNCT02507063
Optic Nerve Sheath Diameter and Intracranial Pressure (ICP) in Children
An observational study of Intracranial Hypertension, run by Anna Rominger.
Trial summary
The use of optic nerve sheath diameter (ONSD) measurements as a non invasive test for raised ICP has many potential benefits. This includes having assessments that can be made at the bedside instead of requiring patient transport to CT or MRI, which in itself can cause a rise in ICP. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Intracranial Hypertension
- What is being tested?
- ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Aug 2018
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children who are 0 - 18 years old who have an invasive intracranial ICP monitoring device admitted to PICU and children who are 0-18 years old who are determined to require a shunt revision following evaluation in the ED.
Who may be able to join
- Children between 0 years and 18 years of age
- Children who are determined to need an invasive intracranial monitoring device in the ED and admitted to the PICU
- Children who undergo VP shunt revisions at the study site
Who cannot join
- Children with an invasive intracranial monitoring device that is malfunctioning
- Prior adverse reactions to ultrasound gel
- Pre-existing ophthalmologic conditions that could cause a baseline increase in ONSD, including glaucoma or severe ocular trauma
- Children with ocular or facial trauma that would impede ONSD measurements
About this study
Official title: Determining the Correlation of Optic Nerve Sheath Diameter With Intracranial Pressure in Children
The use of optic nerve sheath diameter (ONSD) measurements as a non invasive test for raised ICP has many potential benefits. This includes having assessments that can be made at the bedside instead of requiring patient transport to CT or MRI, which in itself can cause a rise in ICP. If ONSD represents an acute and sensitive measurement of elevated ICP, it may prove useful in the emergency department (ED) setting in the evaluation of shunts used for cerebrospinal fluid (CSF) diversion. The investigators hypothesize that ONSD will correlate with measured ICP and thus be a reliable tool for the bedside assessment of ICP. The investigators further hypothesize that ONSD changes will correlate with changes in ICP, making it a useful bedside tool for assessing ICP changes over time. This is a prospective, observational study using a convenience sample. Children who are 0 - 18 years old who have an invasive intracranial ICP monitoring device admitted to the hospital Pediatric Intensive Care Unit (PICU) are eligible for participation in the study. Children who are 0-18 years old who are determined to require a shunt revision following evaluation in the ED will also be included in the study. 10. After the invasive intracranial pressure monitoring device is placed, for every recruited patient, ONSD measurements will be taken and the ICP will be recorded 8 hours post placement and then repeated 3 times a day until the intracranial pressure monitoring device is removed.12. For ventriculoperitoneal (VP) shunt revision patients, the investigators will obtain a measurement just before surgery, immediately post-op, and then 12 hours, 24 hours, and 36 hours post-op. If the patient is otherwise ready for discharge prior to 36 hours, the measurement may be omitted or done early so as to not unnecessarily prolong the hospitalization
- Conditions
- Intracranial Hypertension
- Being tested
- ultrasound
- Medical subject headings
- Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundProcedure or surgery
Ocular ultrasound to look at the optic nerve sheath diameter in patients with an intracranial monitoring device or with a ventriculoperitoneal shunt malfunction requiring revision
| Study group | Role | What they receive |
|---|---|---|
| study subjects | Patients age 0-18 with intracranial monitoring devices in place or requiring a VP shunt revision who receive a ocular ultrasound evaluating ONSD Receives: Procedure: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation (composite of multiple measurements) of ONSD measurements by sonography in patients with intracranial pressure measurements by invasive intracranial monitors.
Measured: 3 years
Secondary outcomes (1)
ONSD measurements by sonography in patients with VP shunt malfunction as evidenced by CT scan
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2015 (estimated)
- Study startJul 2016
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial HypertensionStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anna Rominger
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anna Rominger, University of Louisville
- Investigators
- Anna H Rominger, MD MPH MsC, Study director, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02507063
- Sponsor's protocol ID
- 15.0326
- Status last verified
- May 2017
- First submitted
- 18 Jul 2015
- Last updated
- 24 May 2017
- 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 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Correlation of Optic Nerve Sheath Diameter With Intracranial Pressure in Children
- ClinicalTrials.gov ID
- NCT02507063
- Acronym / sponsor ID
- 15.0326
- Conditions
- Intracranial Hypertension
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Anna RomingerUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 23 Jul 2015 (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 use of optic nerve sheath diameter (ONSD) measurements as a non invasive test for raised ICP has many potential benefits. This includes having assessments that can be made at the bedside instead of requiring patient transport to CT or MRI, which in itself can cause a rise in ICP. If ONSD represents an acute and sensitive measurement of elevated ICP, it may prove useful in the emergency department (ED) setting in the evaluation of shunts used for cerebrospinal fluid (CSF) diversion. The investigators hypothesize that ONSD will correlate with measured ICP and thus be a reliable tool for the bedside assessment of ICP. The investigators further hypothesize that ONSD changes will correlate with changes in ICP, making it a useful bedside tool for assessing ICP changes over time. This is a prospective, observational study using a convenience sample. Children who are 0 - 18 years old who have an invasive intracranial ICP monitoring device admitted to the hospital Pediatric Intensive Care Unit (PICU) are eligible for participation in the study. Children who are 0-18 years old who are determined to require a shunt revision following evaluation in the ED will also be included in the study. 10. After the invasive intracranial pressure monitoring device is placed, for every recruited patient, ONSD measurements will be taken and the ICP will be recorded 8 hours post placement and then repeated 3 times a day until the intracranial pressure monitoring device is removed.12. For ventriculoperitoneal (VP) shunt revision patients, the investigators will obtain a measurement just before surgery, immediately post-op, and then 12 hours, 24 hours, and 36 hours post-op. If the patient is otherwise ready for discharge prior to 36 hours, the measurement may be omitted or done early so as to not unnecessarily prolong the hospitalization
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study subjects | – | Procedure: ultrasoundPatients age 0-18 with intracranial monitoring devices in place or requiring a VP shunt revision who receive a ocular ultrasound evaluating ONSD |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children who are 0 - 18 years old who have an invasive intracranial ICP monitoring device admitted to PICU and children who are 0-18 years old who are determined to require a shunt revision following evaluation in the ED.
Key inclusion criteria (3 listed)
- Children between 0 years and 18 years of age
- Children who are determined to need an invasive intracranial monitoring device in the ED and admitted to the PICU
- Children who undergo VP shunt revisions at the study site
Key exclusion criteria (4 listed)
- Children with an invasive intracranial monitoring device that is malfunctioning
- Prior adverse reactions to ultrasound gel
- Pre-existing ophthalmologic conditions that could cause a baseline increase in ONSD, including glaucoma or severe ocular trauma
- Children with ocular or facial trauma that would impede ONSD measurements
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 |
|---|---|---|
| ultrasoundOcular ultrasound to look at the optic nerve sheath diameter in patients with an intracranial monitoring device or with a ventriculoperitoneal shunt malfunction requiring revision | Procedure or surgery | study subjects |
Primary outcome
The correlation (composite of multiple measurements) of ONSD measurements by sonography in patients with intracranial pressure measurements by invasive intracranial monitors.
Time frame: 3 years
1 secondary outcome
ONSD measurements by sonography in patients with VP shunt malfunction as evidenced by CT scan
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2017.
- 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.
Anna H Rominger, MD MPH MsC study director
University of Louisville
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Hypertension, run by Anna Rominger.
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 3 inclusion and 4 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: withdrawn, as of the sponsor's last update on 24 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
The correlation (composite of multiple measurements) of ONSD measurements by sonography in patients with intracranial pressure measurements by invasive intracranial monitors. (time frame: 3 years). 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 24 May 2017.