We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT01865149
Recruitment Status : Unknown
Verified May 2013 by Yonsei University.
Recruitment status was:  Recruiting
First Posted : May 30, 2013
Last Update Posted : May 30, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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. 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 or disease Intervention/treatment
Hydrocephalus Procedure: retrobulbar ultrasound

Study Design

Study Type : Observational
Estimated Enrollment : 38 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Study Start Date : May 2013
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
both optic nerve sheath diameter Procedure: retrobulbar ultrasound
both optic nerve sheath diameter (the posterior 3mm of the papilla), 5 individual measurement


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Posted: May 30, 2013    Key Record Dates
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