Optic Nerve Sheath Diameter in Patients Undergoing Palatoplasty

NCT ID: NCT03585608

Last Updated: 2018-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-18

Study Completion Date

2018-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cleft Palate

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Neck extension

The neck extension is routine posture during palatoplasty. We will evaluate the change in optic nerve sheath diameters before and after neck extension.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Young-Kug Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Young-Kug Kim, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan medical Center

Seoul, , South Korea

Site Status

Young-Kug Kim

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2018-0756

Identifier Type: -

Identifier Source: org_study_id

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