NCT03585608

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2018

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 13, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

July 18, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2018

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

December 4, 2018

Status Verified

December 1, 2018

Enrollment Period

4 months

First QC Date

July 2, 2018

Last Update Submit

December 3, 2018

Conditions

Cleft Palate

Outcome Measures

Primary Outcomes (1)

  • Difference in optic nerve sheath diameter

    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 Outcomes (1)

  • Difference in optic nerve sheath diameter

    at end of surgery with the neck extended

Interventions

Neck extensionPROCEDURE

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

Eligibility Criteria

Age6 Months - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Asan medical Center

Seoul, 05505, South Korea

Location

Young-Kug Kim

Seoul, South Korea

Location

MeSH Terms

Conditions

Cleft Palate

Condition Hierarchy (Ancestors)

Jaw AbnormalitiesJaw DiseasesMusculoskeletal DiseasesMaxillofacial AbnormalitiesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesStomatognathic DiseasesMouth AbnormalitiesMouth DiseasesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Young-Kug Kim, MD,PhD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 2, 2018

First Posted

July 13, 2018

Study Start

July 18, 2018

Primary Completion

November 22, 2018

Study Completion

November 30, 2018

Last Updated

December 4, 2018

Record last verified: 2018-12

Locations

KR(2)