Preoperative FastingNCT03567915
Ultrasound Assessment of Gastric Emptying of Korean Meals: Rice and Noodle
An observational study of Preoperative Fasting, run by SMG-SNU Boramae Medical Center.
Trial summary
The investigators evaluate gastric emptying time of common Korean meals (rice, noodles) in healthy volunteers. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Preoperative Fasting
- What is being tested?
- Evaluation of gastric volume and content
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2018to May 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 20 years and older
- All sexes
- Adult, Older adult
Study population: Adult healthy volunteers
Who may be able to join
- Adult healthy volunteers
Who cannot join
- History of gastrectomy
- Anatomical abnormalities or mass of stomach
About this study
Official title: Ultrasound Assessment of Gastric Emptying of Korean Meals in Healthy Volunteer: Rice and Noodle
The investigators evaluate gastric emptying time of common Korean meals (rice, noodles) in healthy volunteers.
Read the detailed description
The investigators assess the gastric volume and contents of healthy volunteers at 4, 5, 6, 7, 8 hours after eating common Korean meal (rice or noodle) using a ultrasonography.
- Conditions
- Preoperative Fasting
- Being tested
- Evaluation of gastric volume and content
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of gastric volume and contentOther
The gastric volume and gastric content are assessed at 4, 5, 6, 7, and 8 hours after eating a meal.
| Study group | Role | What they receive |
|---|---|---|
| Rice | Group that healthy volunteers eat rice. Receives: Other: Evaluation of gastric volume and content | |
| Noodle | Group that healthy volunteers eat noodle. Receives: Other: Evaluation of gastric volume and content |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric emptying time
The time for digesting a meal
Measured: 1 hour
Secondary outcomes (4)
Incidence of full stomach
The incidence of full stomach is assessed by using ultrasonography.
Measured: At 4, 5, 6, 7, and 8 hours after eating a meal.
Cross sectional area of the stomach
The cross sectional area of the stomach is assessed by using ultrasonography in the supine and right lateral positions.
Measured: At 4, 5, 6, 7, and 8 hours after eating a meal.
Gastric volume
The volume of stomach is assessed using the following formula; volume of stomach (mL) = 27.0 + 14.6 x cross-sectional area (right lateral position) - 1.28 x age.
Measured: At 4, 5, 6, 7, and 8 hours after eating a meal.
Type of gastric contents
The type of gastric contents is assessed using ultrasonography.
Measured: At 4, 5, 6, 7, and 8 hours after eating a meal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start15 Jun 2018 (estimated)
- Primary completionMay 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative FastingStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SMG-SNU Boramae Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Young Hwang, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03567915
- Sponsor's protocol ID
- 20180504
- Status last verified
- Jun 2018
- First submitted
- 4 May 2018
- Last updated
- 26 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Assessment of Gastric Emptying of Korean Meals in Healthy Volunteer: Rice and Noodle
- ClinicalTrials.gov ID
- NCT03567915
- Acronym / sponsor ID
- 20180504
- Conditions
- Preoperative Fasting
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- SMG-SNU Boramae Medical CenterUniversity, hospital or other
- Study start
- 15 Jun 2018 (estimated)
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 26 Jun 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 investigators evaluate gastric emptying time of common Korean meals (rice, noodles) in healthy volunteers.
Detailed description
The investigators assess the gastric volume and contents of healthy volunteers at 4, 5, 6, 7, 8 hours after eating common Korean meal (rice or noodle) using a ultrasonography.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rice | – | Other: Evaluation of gastric volume and contentGroup that healthy volunteers eat rice. |
| Noodle | – | Other: Evaluation of gastric volume and contentGroup that healthy volunteers eat noodle. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult healthy volunteers
Key inclusion criteria (1 listed)
- Adult healthy volunteers
Key exclusion criteria (2 listed)
- History of gastrectomy
- Anatomical abnormalities or mass of stomach
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 |
|---|---|---|
| Evaluation of gastric volume and contentThe gastric volume and gastric content are assessed at 4, 5, 6, 7, and 8 hours after eating a meal. | Other | Noodle, Rice |
Primary outcome
Gastric emptying time
Time frame: 1 hour
The time for digesting a meal
4 secondary outcomes
Incidence of full stomach
Time frame: At 4, 5, 6, 7, and 8 hours after eating a meal.
Cross sectional area of the stomach
Time frame: At 4, 5, 6, 7, and 8 hours after eating a meal.
Gastric volume
Time frame: At 4, 5, 6, 7, and 8 hours after eating a meal.
Type of gastric contents
Time frame: At 4, 5, 6, 7, and 8 hours after eating a meal.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
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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 Preoperative Fasting, run by SMG-SNU Boramae Medical Center.
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 26 Jun 2018. 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 emptying time (time frame: 1 hour). 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 26 Jun 2018.