HydrocephalusNCT01863329
Comparison of Optic Nerve Sheath Diameter on Retrobulbar Ultrasound Before and After Drainage of Cerebrospinal Fluid in Patient With Hydrocephalus
An observational study of Hydrocephalus, run by Yonsei University at 1 site in South Korea.
Trial summary
Studies in patients with intracranial hypertension have shown a good relationship between optic nerve sheath diameter measured by retrobulbar ultrasound and invasively measured intracranial pressure. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hydrocephalus
- What is being tested?
- retrobulbar ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2013to Sep 2013
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient with hydrocephalus
Who may be able to join
- ASA Ⅰ-Ⅱ
- aged between 20 and 70 year
- hydrocephalus
- general anesthesia for undergoing drainage of cerebrospinal fluid
Who cannot join
- 1. an anatomical or functional abnormality in optic nerve
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, 120-752
About this study
Studies in patients with intracranial hypertension have shown a good relationship between optic nerve sheath diameter measured by retrobulbar ultrasound and invasively measured intracranial pressure. The aim of this study was to evaluate changes in optic nerve sheath diameter before and after drainage of cerebrospinal fluid in patients with hydrocephalus.
- Conditions
- Hydrocephalus
- Being tested
- retrobulbar ultrasound
- Keywords
- Optic nerve sheath diameter, Hydrocephalus, Intracranial hypertension
- Medical subject headings
- Hydrocephalus, Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrobulbar ultrasoundProcedure or surgery
both optic nerve sheath diameter (the posterior 3mm of the papilla), 5 individual measurement
| Study group | Role | What they receive |
|---|---|---|
| both optic nerve sheath diameter | both optic nerve sheath diameter (the posterior 3mm of the papilla), 5 individual measurement Receives: Procedure: retrobulbar ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
both optic nerve sheath diameter (the posterior 3mm of the papilla)
Measured: from induction of general anesthesia to average 15 min after recovery of general anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2013
- Study completionSep 2013
Why it stopped: The investigator resigned on February 28, 2014.
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 Yonsei 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863329
- Sponsor's protocol ID
- 4-2013-0006
- Status last verified
- Dec 2014
- First submitted
- 22 May 2013
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Optic Nerve Sheath Diameter on Retrobulbar Ultrasound Before and After Drainage of Cerebrospinal Fluid in Patient With Hydrocephalus
- ClinicalTrials.gov ID
- NCT01863329
- Acronym / sponsor ID
- 4-2013-0006
- Conditions
- Hydrocephalus
- Keywords
- Optic nerve sheath diameter, Hydrocephalus, Intracranial hypertension
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The investigator resigned on February 28, 2014.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 27 May 2013 (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.
Studies in patients with intracranial hypertension have shown a good relationship between optic nerve sheath diameter measured by retrobulbar ultrasound and invasively measured intracranial pressure. The aim of this study was to evaluate changes in optic nerve sheath diameter before and after drainage of cerebrospinal fluid in patients with hydrocephalus.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| both optic nerve sheath diameter | – | Procedure: retrobulbar ultrasoundboth optic nerve sheath diameter (the posterior 3mm of the papilla), 5 individual measurement |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient with hydrocephalus
Key inclusion criteria (4 listed)
- ASA Ⅰ-Ⅱ
- aged between 20 and 70 year
- hydrocephalus
- general anesthesia for undergoing drainage of cerebrospinal fluid
Key exclusion criteria (1 listed)
- 1. an anatomical or functional abnormality in optic nerve
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 |
|---|---|---|
| retrobulbar ultrasoundboth optic nerve sheath diameter (the posterior 3mm of the papilla), 5 individual measurement | Procedure or surgery | both optic nerve sheath diameter |
Primary outcome
both optic nerve sheath diameter (the posterior 3mm of the papilla)
Time frame: from induction of general anesthesia to average 15 min after recovery of general anesthesia
Results and safety
The study was stopped early (reason given: The investigator resigned on February 28, 2014.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Yonsei University at 1 site in South Korea.
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: stopped early, as of the sponsor's last update on 27 Mar 2019. 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 South Korea. 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 was stopped early (reason given: The investigator resigned on February 28, 2014.). Results are not available in the source record.
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?
both optic nerve sheath diameter (the posterior 3mm of the papilla) (time frame: from induction of general anesthesia to average 15 min after recovery of general anesthesia). 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 27 Mar 2019.