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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01865149
First received: May 22, 2013
Last updated: May 26, 2013
Last verified: May 2013
  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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   1 Year to 19 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01865149     History of Changes
Other Study ID Numbers: 1-2013-0022
Study First Received: May 22, 2013
Last Updated: May 26, 2013
Health Authority: Korea: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 30, 2014