Cleft PalateNCT04683978
Effect of Neck Extension on Intraocular Pressure in Patients Undergoing Palatoplasty
An observational study of Cleft Palate, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the change in intraocular pressure according to the neck extension during palatoplasty in pediatric patients. Read more about this study
- Who is it for?
- Ages 6 to 24 months
- Conditions the study is for
- Cleft Palate
- What is being tested?
- Position
- How many people
- 37 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Feb 2021to 23 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 24 months
- All sexes
- No healthy volunteers
- Child
Study population: Patients who have undergone a palatoplasty with cleft palate and who are 6 months or older and under 24 months
Who may be able to join
- 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
Who cannot join
- Patients who refused to participate in clinical studies
- History of diagnosis of neurologic or ophthalmic disease
- History of neurosurgery or ophthalmic surgery
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Position
- Medical subject headings
- Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PositionOther
Neck extension
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure after neck extension
Intraocular pressure after neck extension during palatoplasty
Measured: at 5 minutes after the position change (neck extension)
Secondary outcomes (3)
Intraocular pressure 10 minutes after anesthetic induction
Intraocular pressure 10 minutes after anesthetic induction during palatoplasty
Measured: at 10 minutes after anesthetic induction (supine position)
Intraocular pressure at end of surgery
Intraocular pressure at end of surgery with neck extension
Measured: immmediately after skin closure (neck extension)
Intraocular pressure 5 minutes after supine position
Intraocular pressure 5 minutes after supine position
Measured: at 5 minutes after the position change to the supine position (after the end of the surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start10 Feb 2021
- Primary completion22 Dec 2021
- Study completion23 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cleft PalateStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young-Kug Kim, MD, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04683978
- Sponsor's protocol ID
- 2020-1854
- Status last verified
- Feb 2022
- First submitted
- 18 Dec 2020
- Last updated
- 16 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37541047
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neck Extension on Intraocular Pressure in Patients Undergoing Palatoplasty
- ClinicalTrials.gov ID
- NCT04683978
- Acronym / sponsor ID
- 2020-1854
- Conditions
- Cleft Palate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 22 Dec 2021 (actual)
- Study completion
- 23 Dec 2021 (actual)
- First posted
- 24 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the change in intraocular pressure according to the neck extension during palatoplasty in pediatric patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients who have undergone a palatoplasty with cleft palate and who are 6 months or older and under 24 months
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Patients who refused to participate in clinical studies
- History of diagnosis of neurologic or ophthalmic disease
- History of neurosurgery or ophthalmic surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PositionNeck extension | Other | – |
Primary outcome
Intraocular pressure after neck extension
Time frame: at 5 minutes after the position change (neck extension)
Intraocular pressure after neck extension during palatoplasty
3 secondary outcomes
Intraocular pressure 10 minutes after anesthetic induction
Time frame: at 10 minutes after anesthetic induction (supine position)
Intraocular pressure at end of surgery
Time frame: immmediately after skin closure (neck extension)
Intraocular pressure 5 minutes after supine position
Time frame: at 5 minutes after the position change to the supine position (after the end of the surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Derived from this study: PubMed 37541047Yu 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.
Related trials for Cleft Palate
Not yet recruiting
Comparative Study of Regional Nerve Blocks in Primary Cleft Palate Repair
Cleft Lip, Cleft Palate +/- Lip
Not yet recruiting
Quadratus Lumborum Block for Iliac Bone Harvest in Pediatric Cleft Alveolus Repair
Cleft Lip Palate
Not yet recruiting
Furlow With Buccinator and Fistula Formation
Cleft Palate
RecruitingPhase 3
Nebulized Bupivacaine Analgesia for Cleft Palate Repair
Cleft Palate
RecruitingObservational study
Perceptions of High and Low Intensity Speech Intervention in Children With a Cleft Palate
Cleft Lip and Palate, Cleft Palate Children
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cleft Palate, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure after neck extension (time frame: at 5 minutes after the position change (neck extension)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04683978, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2022.