Effect of Neck Extension on Intraocular Pressure in Patients Undergoing Palatoplasty

NCT04683978 | Completed

• 1 other identifier: 2020-1854
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the change in intraocular pressure according to the neck extension during palatoplasty in pediatric patients.

Conditions

Cleft Palate

Outcome Measures

Primary Outcomes (1)

• Intraocular pressure after neck extension

  Intraocular pressure after neck extension during palatoplasty

  at 5 minutes after the position change (neck extension)

Secondary Outcomes (3)

• Intraocular pressure 10 minutes after anesthetic induction

  at 10 minutes after anesthetic induction (supine position)

• Intraocular pressure at end of surgery

  immmediately after skin closure (neck extension)

• Intraocular pressure 5 minutes after supine position

  at 5 minutes after the position change to the supine position (after the end of the surgery)

Interventions

Position OTHER

Neck extension

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

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 with ASA class 1-2
• Patients who agree to voluntarily participate in this study

You may not qualify if:

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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan medical Center

Seoul, 05505, South Korea

Location

Related Publications (1)

• Yu J, Park JY, Jeong WS, Oh TS, Kim JY, Kim YK. Effect of neck extension on intraocular pressure in paediatric patients undergoing palatoplasty. J Plast Reconstr Aesthet Surg. 2023 Oct;85:309-315. doi: 10.1016/j.bjps.2023.07.014. Epub 2023 Jul 16.

  PMID: 37541047 DERIVED

MeSH Terms

Conditions

Cleft Palate

Interventions

Patient Positioning

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 24, 2020
• Study Start: February 10, 2021
• Primary Completion: December 22, 2021
• Study Completion: December 23, 2021
• Last Updated: February 16, 2022

Record last verified: 2022-02

Locations

KR (1)