Cerebral PalsyNCT05185336
Ultrasound Assessed Gastric Volume in the Fasted Pediatric Cerebral Palsy Patients
An observational study of Cerebral Palsy, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
In patients with cerebral palsy, delayed gastric emptying and esophageal sphincter dysfunction are very commonly observed. Pulmonary aspiration of gastric contents causes aspiration pneumonia, which greatly affects patients' prognosis, including hospital stay and mortality. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- ultrasound assessment
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Feb 2022to 28 Feb 2022
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: patients with cerebral palsy under the age of 18 scheduled surgery under general anesthesia
Who may be able to join
- patients with cerebral palsy under the age of 18 scheduled surgery under general anesthesia
Who cannot join
- the patient who feed through Levin tube or gastrostomy tube
- refusal to participate
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Jiwon Han, fellow, 82-10-3447-1988, yesuroon@gmail.com
About this study
Official title: Ultrasound Assessment of Gastric Volume and Aspiration Risk Evaluation in the Fasted Pediatric Cerebral Palsy Patients.
In patients with cerebral palsy, delayed gastric emptying and esophageal sphincter dysfunction are very commonly observed.
Pulmonary aspiration of gastric contents causes aspiration pneumonia, which greatly affects patients' prognosis, including hospital stay and mortality.
In the case of patients with cerebral palsy, there is a limitation in respiratory function, so more attention is required.
Therefore, this study aims to evaluate the risk of aspiration by measuring gastric volume after fasting for surgery in children with cerebral palsy.
- Conditions
- Cerebral Palsy
- Being tested
- ultrasound assessment
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound assessmentDiagnostic test
gastric volume assessment by ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
gastric volume
-7.8 + (3.5 x RLD CSA) + 0.127 X age (months)
Measured: preoperative 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start10 Feb 2022 (estimated)
- Primary completion10 Feb 2022 (estimated)
- Study completion28 Feb 2022 (estimated)
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 Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JiWon Han, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185336
- Sponsor's protocol ID
- B-2104-681-301
- Status last verified
- Dec 2021
- First submitted
- 22 Dec 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Publications
Han J, Na HS, Min S, Shin HJ. Preoperative gastric volume assessment using ultrasound in cerebral palsy pediatric patients: a prospective observational study. Braz J Anesthesiol. 2024 Sep-Oct;74(5):844541. doi: 10.1016/j.bjane.2024.844541. Epub 2024 Jul 16.
PubMed 39025325
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Assessment of Gastric Volume and Aspiration Risk Evaluation in the Fasted Pediatric Cerebral Palsy Patients.
- ClinicalTrials.gov ID
- NCT05185336
- Acronym / sponsor ID
- B-2104-681-301
- Conditions
- Cerebral Palsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 10 Feb 2022 (estimated)
- Primary completion
- 10 Feb 2022 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 11 Jan 2022 (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.
In patients with cerebral palsy, delayed gastric emptying and esophageal sphincter dysfunction are very commonly observed.
Pulmonary aspiration of gastric contents causes aspiration pneumonia, which greatly affects patients' prognosis, including hospital stay and mortality.
In the case of patients with cerebral palsy, there is a limitation in respiratory function, so more attention is required.
Therefore, this study aims to evaluate the risk of aspiration by measuring gastric volume after fasting for surgery in children with cerebral palsy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- patients with cerebral palsy under the age of 18 scheduled surgery under general anesthesia
Key inclusion criteria (1 listed)
- patients with cerebral palsy under the age of 18 scheduled surgery under general anesthesia
Key exclusion criteria (2 listed)
- the patient who feed through Levin tube or gastrostomy tube
- refusal to participate
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 |
|---|---|---|
| ultrasound assessmentgastric volume assessment by ultrasound | Diagnostic test | – |
Primary outcome
gastric volume
Time frame: preoperative 20 minutes
-7.8 + (3.5 x RLD CSA) + 0.127 X age (months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Derived from this study: PubMed 39025325Han J, Na HS, Min S, Shin HJ. Preoperative gastric volume assessment using ultrasound in cerebral palsy pediatric patients: a prospective observational study. Braz J Anesthesiol. 2024 Sep-Oct;74(5):844541. doi: 10.1016/j.bjane.2024.844541. Epub 2024 Jul 16.
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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.
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 Cerebral Palsy, run by Seoul National University Bundang Hospital 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 11 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiwon Han, Dr (82-10-3447-1988, yesuroon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gastric volume (time frame: preoperative 20 minutes). 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 NCT05185336, 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 11 Jan 2022.