Optic Nerve Sheath Diameter in Patients Undergoing Palatoplasty

Cleft Palate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03585608
• Other study ID #: 2018-0756
• Status: Completed
• Start date: July 18, 2018
• Est. completion date: November 30, 2018

Study information

• Verified date: December 2018
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 30, 2018
• Est. primary completion date: November 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Cleft Palate

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Asan medical Center	Seoul
Korea, Republic of	Young-Kug Kim	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	at end of surgery with the neck extended