- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01865149
Comparison of Optic Nerve Sheath Diameter on Retrobulbar Ultrasonography Before and After Drainage of Cerebrospinal Fluid in Pediatric Patient With Hydrocephalus
May 26, 2013 updated by: Yonsei University
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 Overview
Study Type
Observational
Enrollment (Anticipated)
38
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Seoul, Korea, Republic of, 120-752
- Recruiting
- Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute,
-
Contact:
- Hyunzu Kim, MD
- Phone Number: 82-2-2228-2422
- Email: aneshyunzu@yuhs.ac
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 19 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patient with hydrocephalus
Description
Inclusion Criteria:
- ASA Ⅰ-Ⅱ
- aged between 1 and 19 year
- hydrocephalus
- general anesthesia for undergoing drainage of cerebrospinal fluid
Exclusion Criteria:
1. an anatomical or functional abnormality in optic nerve
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
both optic nerve sheath diameter
|
both optic nerve sheath diameter (the posterior 3mm of the papilla), 5 individual measurement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
both optic nerve sheath diameter (the posterior 3mm of the papilla)
Time Frame: For day 1 from induction of general anesthesia to average 15 min after recovery of general anesthesia
|
For day 1 from induction of general anesthesia to average 15 min after recovery of general anesthesia
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Anticipated)
May 1, 2014
Study Completion (Anticipated)
May 1, 2014
Study Registration Dates
First Submitted
May 22, 2013
First Submitted That Met QC Criteria
May 26, 2013
First Posted (Estimate)
May 30, 2013
Study Record Updates
Last Update Posted (Estimate)
May 30, 2013
Last Update Submitted That Met QC Criteria
May 26, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1-2013-0022
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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