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Optic Nerve Sheath Diameter in Patients Undergoing Palatoplasty

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ClinicalTrials.gov Identifier: NCT03585608
Recruitment Status : Completed
First Posted : July 13, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Young-Kug Kim, Asan Medical Center

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.

Condition or disease Intervention/treatment
Cleft Palate Procedure: Neck extension

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 7 Days
Official Title: Effect of Neck Extension on Optic Nerve Sheath Diameter in Patients Undergoing Palatoplasty
Actual Study Start Date : July 18, 2018
Actual Primary Completion Date : November 22, 2018
Actual Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: 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.


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   6 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

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): NCT03585608


Locations
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Korea, Republic of
Asan medical Center
Seoul, Korea, Republic of, 05505
Young-Kug Kim
Seoul, Korea, Republic of
Sponsors and Collaborators
Asan Medical Center
Investigators
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Principal Investigator: Young-Kug Kim, MD,PhD Asan Medical Center

Additional Information:

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Responsible Party: Young-Kug Kim, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03585608     History of Changes
Other Study ID Numbers: 2018-0756
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cleft Palate
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic Diseases
Mouth Abnormalities
Mouth Diseases
Stomatognathic System Abnormalities
Congenital Abnormalities