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Comparison of Optic Nerve Sheath Diameter on Retrobulbar Ultrasonography Before and After Drainage of Cerebrospinal Fluid in Pediatric Patient With Hydrocephalus

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2013 by Yonsei University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01865149
First Posted: May 30, 2013
Last Update Posted: May 30, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yonsei University
  Purpose
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.

Condition Intervention
Hydrocephalus Procedure: retrobulbar ultrasound

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 38
Study Start Date: May 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
both optic nerve sheath diameter Procedure: retrobulbar ultrasound
both optic nerve sheath diameter (the posterior 3mm of the papilla), 5 individual measurement

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patient with hydrocephalus
Criteria

Inclusion Criteria:

  1. ASA Ⅰ-Ⅱ
  2. aged between 1 and 19 year
  3. hydrocephalus
  4. general anesthesia for undergoing drainage of cerebrospinal fluid

Exclusion Criteria:

1. an anatomical or functional abnormality in optic nerve

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865149


Contacts
Contact: Hyunzu Kim, MD 82-2-2228-2422 aneshyunzu@yuhs.ac

Locations
Korea, Republic of
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Hyunzu Kim, MD    82-2-2228-2422    aneshyunzu@yuhs.ac   
Sponsors and Collaborators
Yonsei University
  More Information

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01865149     History of Changes
Other Study ID Numbers: 1-2013-0022
First Submitted: May 22, 2013
First Posted: May 30, 2013
Last Update Posted: May 30, 2013
Last Verified: May 2013

Keywords provided by Yonsei University:
Child
Optic nerve sheath diameter
Hydrocephalus
Intracranial hypertension

Additional relevant MeSH terms:
Hydrocephalus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases