FastingGUSNCT03155776
Estimation of Preoperative Gastric Volume Using Ultrasound
An observational study of Fasting, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Aspiration of gastric contents can be a serious anesthetic related complication. Gastric antral sonography prior to anesthesia may have a role in identifying pediatric patients at risk of aspiration. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Fasting
- What is being tested?
- GUS
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Jun 2017to 1 Apr 2019
- 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 Up to 1 year
- All sexes
- Child
Study population: Infants undergoing general anesthesia for abdominal surgery
Who may be able to join
- Infants undergoing general anesthesia with endotracheal intubation were included in this study
Who cannot join
- a recent (≤1 month) history of oesophageal or gastric surgery, gastrostomy or ileostomy, diaphragmatic hernia, emergent surgery, or a prolonged duration (>5 min) between completion of US assessment and suctioning of gastric contents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Assessment of Gastric Volume in Infants Undergoing General Anesthesia: Validation Study
Aspiration of gastric contents can be a serious anesthetic related complication. Gastric antral sonography prior to anesthesia may have a role in identifying pediatric patients at risk of aspiration. The investigator examined the relationship between sonographic antral area and endoscopically suctioned gastric volumes infants.
- Conditions
- Fasting
- Being tested
- GUS
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GUSDiagnostic test
gastric volume estimation using gastric ultrasound was performed immediately after anesthetic induction, and after aspirating the residual gastric contents using nasogastric tube
| Study group | Role | What they receive |
|---|---|---|
| GUS_infants | Infants patient undergoing general anesthesia for abdominal surgery Receives: Diagnostic Test: GUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
gastric antral cross sectional area
ultrasound assessment of gastric antral cross sectional area
Measured: immediate after anesthetic induction within 1 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start15 Jun 2017
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
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 FastingStudies of the same condition, open and under way.
- More trials run by Seoul National University 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03155776
- Sponsor's protocol ID
- H 1703-183-843
- Acronym
- GUS
- Status last verified
- Feb 2021
- First submitted
- 15 May 2017
- Last updated
- 4 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim EH, Yoon HC, Lee JH, Kim HS, Jang YE, Ji SH, Cho SA, Kim JT. Prediction of gastric fluid volume by ultrasonography in infants undergoing general anaesthesia. Br J Anaesth. 2021 Aug;127(2):275-280. doi: 10.1016/j.bja.2021.03.039. Epub 2021 May 25.
PubMed 34045064
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Assessment of Gastric Volume in Infants Undergoing General Anesthesia: Validation Study
- ClinicalTrials.gov ID
- NCT03155776
- Acronym / sponsor ID
- GUS / H 1703-183-843
- Conditions
- Fasting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 16 May 2017 (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.
Aspiration of gastric contents can be a serious anesthetic related complication. Gastric antral sonography prior to anesthesia may have a role in identifying pediatric patients at risk of aspiration. The investigator examined the relationship between sonographic antral area and endoscopically suctioned gastric volumes infants.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GUS_infants | – | Diagnostic Test: GUSInfants patient undergoing general anesthesia for abdominal surgery |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Age groups
- Child
- Study population
- Infants undergoing general anesthesia for abdominal surgery
Key inclusion criteria (1 listed)
- Infants undergoing general anesthesia with endotracheal intubation were included in this study
Key exclusion criteria (1 listed)
- a recent (≤1 month) history of oesophageal or gastric surgery, gastrostomy or ileostomy, diaphragmatic hernia, emergent surgery, or a prolonged duration (>5 min) between completion of US assessment and suctioning of gastric contents
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 |
|---|---|---|
| GUSgastric volume estimation using gastric ultrasound was performed immediately after anesthetic induction, and after aspirating the residual gastric contents using nasogastric tube | Diagnostic test | GUS_infants |
Primary outcome
gastric antral cross sectional area
Time frame: immediate after anesthetic induction within 1 minutes.
ultrasound assessment of gastric antral cross sectional area
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 Feb 2021.
- Derived from this study: PubMed 34045064Kim EH, Yoon HC, Lee JH, Kim HS, Jang YE, Ji SH, Cho SA, Kim JT. Prediction of gastric fluid volume by ultrasonography in infants undergoing general anaesthesia. Br J Anaesth. 2021 Aug;127(2):275-280. doi: 10.1016/j.bja.2021.03.039. Epub 2021 May 25.
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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.
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 Fasting, run by Seoul National University 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 1 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 Feb 2021. 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?
gastric antral cross sectional area (time frame: immediate after anesthetic induction within 1 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 NCT03155776, 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 4 Feb 2021.