Cleft PalateNCT03585608
Optic Nerve Sheath Diameter in Patients Undergoing Palatoplasty
An observational study of Cleft Palate, run by Asan Medical Center at 2 sites in South Korea.
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. 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?
- Neck extension
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 18 Jul 2018to 30 Nov 2018
- How long will I take part?
- 7 Days
- 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 who agree to voluntarily participate in this study
- Patients with ASA class 1-2
Who cannot join
- History of diagnosis of neurologic or ophthalmic disease
- History of neurosurgery or ophthalmic surgery
- Patients who refused to participate in clinical studies
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Effect of Neck Extension on Optic Nerve Sheath Diameter in Patients Undergoing Palatoplasty
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.
Read the 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.
- Conditions
- Cleft Palate
- Being tested
- Neck extension
- Medical subject headings
- Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neck extensionProcedure or surgery
The neck extension is routine posture during palatoplasty. We will evaluate the change in optic nerve sheath diameters before and after neck extension.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 minutes after neck extension
Secondary 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
Measured: at end of surgery with the neck extended
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start18 Jul 2018
- Primary completion22 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 30 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young-Kug Kim, Asan Medical Center
- Investigators
- Young-Kug Kim, MD,PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03585608
- Sponsor's protocol ID
- 2018-0756
- Status last verified
- Dec 2018
- First submitted
- 2 Jul 2018
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neck Extension on Optic Nerve Sheath Diameter in Patients Undergoing Palatoplasty
- ClinicalTrials.gov ID
- NCT03585608
- Acronym / sponsor ID
- 2018-0756
- Conditions
- Cleft Palate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 22 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 13 Jul 2018 (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 evaluate the change of the optic nerve sheath diameter according to the change of the neck position in pediatric patients undergoing palatoplasty.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
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 who agree to voluntarily participate in this study
- Patients with ASA class 1-2
Key exclusion criteria (3 listed)
- History of diagnosis of neurologic or ophthalmic disease
- History of neurosurgery or ophthalmic surgery
- Patients who refused to participate in clinical studies
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 |
|---|---|---|
| Neck extensionThe neck extension is routine posture during palatoplasty. We will evaluate the change in optic nerve sheath diameters before and after neck extension. | Procedure or surgery | – |
Primary outcome
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
1 secondary outcome
Difference in optic nerve sheath diameter
Time frame: at end of surgery with the neck extended
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 4 Dec 2018.
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.
Young-Kug Kim, MD,PhD principal investigator
Asan Medical Center
2 sites 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 2 sites 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 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Difference in optic nerve sheath diameter (time frame: 10 minutes after neck extension). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Dec 2018.