Aspiration, RespiratoryNCT04918277
Gastric Volume in the Fasted Pediatric Cerebral Palsy Patients
An observational study of Aspiration, Respiratory and Cerebral Palsy, run by Seoul National University Bundang Hospital.
Trial summary
In children with cerebral palsy, the gastric volume is measured through ultrasound after fasting before surgery to evaluate whether the risk of aspiration is higher than that of the general population. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Aspiration, Respiratory, Cerebral Palsy
- What is being tested?
- Assessment of gastric volume
- Type of treatment
- Medical device
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 5 Jun 2021to 30 Aug 2022
- How long will I take part?
- 10 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with cerebral palsy under the age of 18 undergoing surgery under general anesthesia
Who may be able to join
- Patients with cerebral palsy under the age of 18 undergoing surgery under general anesthesia
Who cannot join
- Levin tube or gastrostomy tube in situ
- Decline to participate
About this study
Official title: Ultrasound Assessment of Gastric Volume and Aspiration Risk Evaluation in the Fasted Pediatric Cerebral Palsy Patients
In children with cerebral palsy, the gastric volume is measured through ultrasound after fasting before surgery to evaluate whether the risk of aspiration is higher than that of the general population.
- Conditions
- Aspiration, Respiratory, Cerebral Palsy
- Being tested
- Assessment of gastric volume
- Medical subject headings
- Respiratory Aspiration, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of gastric volumeDevice
Measuring the cross-sectional area of stomach in supine and right lateral decubitus
What is being measured
The primary outcome is the main question the study is designed to answer.
gastric volume
Volume = -7.8 + (3.5 x RLD CSA) + 0.127 X age (months)
Measured: preoperative 1 days to postoperative 1 days
Secondary outcomes (1)
Grade of gastric fullness
Grade 0: Neither in supine, right lateral decubitus / Grade 1: stomach content only in lateral decubitus , Grade 2: Both in supine, lateral decubitus
Measured: preoperative 1 days to postoperative 1 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start5 Jun 2021 (estimated)
- Primary completion30 May 2022 (estimated)
- Study completion30 Aug 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 Aspiration, RespiratoryStudies 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)
- Target duration
- 10 Days
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
- NCT04918277
- Sponsor's protocol ID
- L-2021-365
- Status last verified
- Jun 2021
- First submitted
- 3 Jun 2021
- Last updated
- 8 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Spencer AO, Walker AM, Yeung AK, Lardner DR, Yee K, Mulvey JM, Perlas A. Ultrasound assessment of gastric volume in the fasted pediatric patient undergoing upper gastrointestinal endoscopy: development of a predictive model using endoscopically suctioned volumes. Paediatr Anaesth. 2015 Mar;25(3):301-8. doi: 10.1111/pan.12581. Epub 2014 Dec 11.
PubMed 25495405
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. 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
- NCT04918277
- Acronym / sponsor ID
- L-2021-365
- Conditions
- Aspiration, Respiratory, 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
- 5 Jun 2021 (estimated)
- Primary completion
- 30 May 2022 (estimated)
- Study completion
- 30 Aug 2022 (estimated)
- First posted
- 8 Jun 2021 (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 children with cerebral palsy, the gastric volume is measured through ultrasound after fasting before surgery to evaluate whether the risk of aspiration is higher than that of the general population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Days
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 undergoing surgery under general anesthesia
Key inclusion criteria (1 listed)
- Patients with cerebral palsy under the age of 18 undergoing surgery under general anesthesia
Key exclusion criteria (2 listed)
- Levin tube or gastrostomy tube in situ
- Decline 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 |
|---|---|---|
| Assessment of gastric volumeMeasuring the cross-sectional area of stomach in supine and right lateral decubitus | Device | – |
Primary outcome
gastric volume
Time frame: preoperative 1 days to postoperative 1 days
Volume = -7.8 + (3.5 x RLD CSA) + 0.127 X age (months)
1 secondary outcome
Grade of gastric fullness
Time frame: preoperative 1 days to postoperative 1 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Background: PubMed 25495405Spencer AO, Walker AM, Yeung AK, Lardner DR, Yee K, Mulvey JM, Perlas A. Ultrasound assessment of gastric volume in the fasted pediatric patient undergoing upper gastrointestinal endoscopy: development of a predictive model using endoscopically suctioned volumes. Paediatr Anaesth. 2015 Mar;25(3):301-8. doi: 10.1111/pan.12581. Epub 2014 Dec 11.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Aspiration, Respiratory and Cerebral Palsy, run by Seoul National University Bundang Hospital.
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 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
gastric volume (time frame: preoperative 1 days to postoperative 1 days). 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 NCT04918277, 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 8 Jun 2021.