Optic Nerve Sheath Diameter in Patients Undergoing Palatoplasty

December 3, 2018 updated by: Young-Kug Kim, Asan Medical Center

Effect of Neck Extension on Optic Nerve Sheath Diameter in Patients Undergoing Palatoplasty

The purpose of this study is to evaluate the change of the optic nerve sheath diameter according to the change of the neck position in pediatric patients undergoing palatoplasty.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Palatoplaty is performed under neck extension in patients with cleft palate. The purpose of this study is to evaluate the effect of neck extension on the ultrasonographic optic nerve sheath diameter during palatoplasty.

Study Type

Observational

Enrollment (Actual)

30

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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of
        • Young-Kug Kim

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

6 months to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who have undergone a palatoplasty with cleft palate and who are 6 months or older and under 24 months

Description

Inclusion Criteria:

  • Patients who have undergone a palatoplasty with cleft palate and who are 6 months or older and under 24 months
  • Patients who agree to voluntarily participate in this study
  • Patients with ASA class 1-2

Exclusion Criteria:

  • History of diagnosis of neurologic or ophthalmic disease
  • History of neurosurgery or ophthalmic surgery
  • Patients who refused to participate in clinical studies

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: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in optic nerve sheath diameter
Time Frame: 10 minutes after neck extension
Difference between the optic nerve sheath diameter measured during supine position without neck extension and the optic nerve sheath diameter measured during supine position with neck extension in patients undergoing palatoplasty
10 minutes after neck extension

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in optic nerve sheath diameter
Time Frame: at end of surgery with the neck extended
Difference between the optic nerve sheath diameter measured during supine position without neck extension and the optic nerve sheath diameter measured during supine position with neck extension in patients undergoing palatoplasty
at end of surgery with the neck extended

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

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 (Actual)

July 18, 2018

Primary Completion (Actual)

November 22, 2018

Study Completion (Actual)

November 30, 2018

Study Registration Dates

First Submitted

July 2, 2018

First Submitted That Met QC Criteria

July 2, 2018

First Posted (Actual)

July 13, 2018

Study Record Updates

Last Update Posted (Actual)

December 4, 2018

Last Update Submitted That Met QC Criteria

December 3, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-0756

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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