Gastric EmptyingNCT03636828
Gastric Emptying Time of a Rice-based Meal
An observational study of Gastric Emptying, run by Kangbuk Samsung Hospital at 1 site in South Korea.
Trial summary
Adequate preoperative fasting is critical in preventing pulmonary aspiration of gastric content. Ultrasonography is considering as a useful test assessing the volume of gastric contents, but the emptying time of a rice-based meal (Asian foods) in healthy populations was not clear. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Gastric Emptying
- What is being tested?
- ultrasonographic measurement of gastric antral cross-sectional area
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Oct 2018to 27 Dec 2018
- 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 18 to 50 years
- All sexes
- Adult
Study population: Study population is 10 healthy volunteers.
Who may be able to join
- age over 18 years old
- body mass index between 18.5 and 29.9 kg/m2
Who cannot join
- history of gastrointestinal disease such as history of surgery of upper abdomen, hiatal hernia and gastroesophageal reflux,
- diabetes mellitus
- chronic kidney disease
- pregnancy
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kangbuk Samsung Hospital
Seoul, 110-746
Taejong Song, MD PhD, 82-2-2001-2582, taejong.song@gmail.com
Taejong Song, MD, PhD
About this study
Official title: Gastric Emptying Time of a Rice-based Meal Using Serial Sonographic Assessment
Adequate preoperative fasting is critical in preventing pulmonary aspiration of gastric content. Ultrasonography is considering as a useful test assessing the volume of gastric contents, but the emptying time of a rice-based meal (Asian foods) in healthy populations was not clear. The objective of this study was to investigate the minimum fasting time required for adequate gastric emptying after the ingestion of a rice-based meal.
Read the detailed description
Aspiration of gastric contents into the lungs in surgical patients is a rare, but serious adverse event. Because a proper preoperative fasting is mandatory before anesthesia to prevent this severe complication, patients undergoing elective surgery have traditionally asked to fast overnight to ensure that their stomachs are empty. However, it is difficult and uncomfortable for patients not to eat or drink, particularly for those scheduled for surgery later in the day. Fasting may lead to thirst, hunger, anxiety, and tiredness, along with the potential for hypoglycemia and dehydration. Moreover, prolonged preoperative starvation triggers a metabolic response that precipitates gluconeogenesis and increases the organic response to trauma [7,8] and leads to delayed recovery after surgery. Avoiding inordinate fasting before surgery markedly reduces postoperative insulin resistance which has beneficial effects on postoperative glucose and protein metabolism.
Current guidelines by the American Society of Anesthesiologists (ASA) recommend a minimum of 6 hours after a light meal (toast and clear fluid) and 8 hours if the meal includes fried or fatty foods. In the era of evidence-based medicine, however, these fasting recommendations to keep a patient in preoperative fasting of 6-8 hours after the intake of solid meal are derived from survey opinions solicited from 470 active members of the ASA membership despite insufficient literature.
Recent studies have shown that real-time ultrasonography can provide reliable information about the nature (clear fluid, solid, or none) and volume of gastric content, being a non-invasive, inexpensive and safe method. The ultrasonographic measurement of antral cross-sectional area (CSA) is used for the assessment of gastric emptying in diabetic or dyspeptic patients and clinical investigations in obstetrical anesthesia. Thus, we designed this study to evaluate scientifically the gastric emptying time of solid meal using serial sonographic assessment in healthy volunteers. (Especially, there was no study to evaluate the gastric emptying time of a rice-based meal.) The objective of this study was to confirm or confront the minimum fasting time required for adequate gastric emptying for a rice-based meal (Asian foods), according to the suggestion of current guideline.
- Conditions
- Gastric Emptying
- Being tested
- ultrasonographic measurement of gastric antral cross-sectional area
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonographic measurement of gastric antral cross-sectional areaDiagnostic test
Each participant fasted for 10 hours and subjected to a baseline gastric ultrasound and serial sonographic gastric evaluations was performed every hour after 2 hours of the ingestion of a 420 g, 536 Kcal rice-based meal (bibimbap) until the stomach was completely empty.
What is being measured
The primary outcome is the main question the study is designed to answer.
ultrasonographic measurement of gastric antral cross-sectional area (CSA)
Measured: 2 hours after the ingestion of a sold meal
ultrasonographic measurement of gastric antral cross-sectional area (CSA)
Measured: 3 hours after the ingestion of a sold meal
ultrasonographic measurement of gastric antral cross-sectional area (CSA)
Measured: 4 hours after the ingestion of a sold meal
ultrasonographic measurement of gastric antral cross-sectional area (CSA)
Measured: 5 hours after the ingestion of a sold meal
ultrasonographic measurement of gastric antral cross-sectional area (CSA)
Measured: 6 hours after the ingestion of a sold meal
ultrasonographic measurement of gastric antral cross-sectional area (CSA)
Measured: 7 hours after the ingestion of a sold meal
ultrasonographic measurement of gastric antral cross-sectional area (CSA)
Measured: 8 hours after the ingestion of a sold meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start15 Oct 2018
- Primary completion27 Dec 2018 (estimated)
- Study completion27 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric EmptyingStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kangbuk Samsung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taejong Song, Kangbuk Samsung Hospital
- Investigators
- Taejong Song, MD, PhD, Principal investigator, Kangbuk Samsung Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636828
- Sponsor's protocol ID
- KBSMC2018-08-001
- Status last verified
- Nov 2018
- First submitted
- 6 Aug 2018
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Emptying Time of a Rice-based Meal Using Serial Sonographic Assessment
- ClinicalTrials.gov ID
- NCT03636828
- Acronym / sponsor ID
- KBSMC2018-08-001
- Conditions
- Gastric Emptying
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Kangbuk Samsung HospitalUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 27 Dec 2018 (estimated)
- Study completion
- 27 Dec 2018 (estimated)
- First posted
- 17 Aug 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.
Adequate preoperative fasting is critical in preventing pulmonary aspiration of gastric content. Ultrasonography is considering as a useful test assessing the volume of gastric contents, but the emptying time of a rice-based meal (Asian foods) in healthy populations was not clear. The objective of this study was to investigate the minimum fasting time required for adequate gastric emptying after the ingestion of a rice-based meal.
Detailed description
Aspiration of gastric contents into the lungs in surgical patients is a rare, but serious adverse event. Because a proper preoperative fasting is mandatory before anesthesia to prevent this severe complication, patients undergoing elective surgery have traditionally asked to fast overnight to ensure that their stomachs are empty. However, it is difficult and uncomfortable for patients not to eat or drink, particularly for those scheduled for surgery later in the day. Fasting may lead to thirst, hunger, anxiety, and tiredness, along with the potential for hypoglycemia and dehydration. Moreover, prolonged preoperative starvation triggers a metabolic response that precipitates gluconeogenesis and increases the organic response to trauma [7,8] and leads to delayed recovery after surgery. Avoiding inordinate fasting before surgery markedly reduces postoperative insulin resistance which has beneficial effects on postoperative glucose and protein metabolism.
Current guidelines by the American Society of Anesthesiologists (ASA) recommend a minimum of 6 hours after a light meal (toast and clear fluid) and 8 hours if the meal includes fried or fatty foods. In the era of evidence-based medicine, however, these fasting recommendations to keep a patient in preoperative fasting of 6-8 hours after the intake of solid meal are derived from survey opinions solicited from 470 active members of the ASA membership despite insufficient literature.
Recent studies have shown that real-time ultrasonography can provide reliable information about the nature (clear fluid, solid, or none) and volume of gastric content, being a non-invasive, inexpensive and safe method. The ultrasonographic measurement of antral cross-sectional area (CSA) is used for the assessment of gastric emptying in diabetic or dyspeptic patients and clinical investigations in obstetrical anesthesia. Thus, we designed this study to evaluate scientifically the gastric emptying time of solid meal using serial sonographic assessment in healthy volunteers. (Especially, there was no study to evaluate the gastric emptying time of a rice-based meal.) The objective of this study was to confirm or confront the minimum fasting time required for adequate gastric emptying for a rice-based meal (Asian foods), according to the suggestion of current guideline.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- Study population is 10 healthy volunteers.
Key inclusion criteria (2 listed)
- age over 18 years old
- body mass index between 18.5 and 29.9 kg/m2
Key exclusion criteria (4 listed)
- history of gastrointestinal disease such as history of surgery of upper abdomen, hiatal hernia and gastroesophageal reflux,
- diabetes mellitus
- chronic kidney disease
- pregnancy
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 |
|---|---|---|
| ultrasonographic measurement of gastric antral cross-sectional areaEach participant fasted for 10 hours and subjected to a baseline gastric ultrasound and serial sonographic gastric evaluations was performed every hour after 2 hours of the ingestion of a 420 g, 536 Kcal rice-based meal (bibimbap) until the stomach was completely empty. | Diagnostic test | – |
Primary outcome
ultrasonographic measurement of gastric antral cross-sectional area (CSA)
Time frame: 2 hours after the ingestion of a sold meal
ultrasonographic measurement of gastric antral cross-sectional area (CSA)
Time frame: 3 hours after the ingestion of a sold meal
ultrasonographic measurement of gastric antral cross-sectional area (CSA)
Time frame: 4 hours after the ingestion of a sold meal
ultrasonographic measurement of gastric antral cross-sectional area (CSA)
Time frame: 5 hours after the ingestion of a sold meal
ultrasonographic measurement of gastric antral cross-sectional area (CSA)
Time frame: 6 hours after the ingestion of a sold meal
ultrasonographic measurement of gastric antral cross-sectional area (CSA)
Time frame: 7 hours after the ingestion of a sold meal
ultrasonographic measurement of gastric antral cross-sectional area (CSA)
Time frame: 8 hours after the ingestion of a sold meal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
- Individual participant dataSharing planned: No
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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.
Taejong Song, MD, PhD principal investigator
Kangbuk Samsung Hosptial
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 Gastric Emptying, run by Kangbuk Samsung 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 2 inclusion and 4 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 29 Nov 2018. 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 Taejong Song, MD, PhD (+821040358405, taejong.song@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ultrasonographic measurement of gastric antral cross-sectional area (CSA) (time frame: 2 hours after the ingestion of a sold meal). The study lists 7 primary outcomes in all. 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 29 Nov 2018.