Gastric VolumeNCT04875845
Comparison of Gastric Volume After 6-hour and 8-hour Fasting in Patient Scheduled for Elective Surgery
An observational study of Gastric Volume and Ultrasonography, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Preoperative fasting was a common practice to decrease perioperative aspiration risk. Duration of fasting was proportional to gastric volume. Short fasting duration may increase aspiration risk. However, prolonged perioperative fasting duration may lead to dehydration and hypoglycemia. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Gastric Volume, Ultrasonography
- What is being tested?
- Fasting for elective surgery
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 37 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2019to 30 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: This was a cohort study for 37 subjects from January to February 2019. Subjects were patients scheduled for elective non-digestive surgery in Cipto Mangunkusumo Hospital
Who may be able to join
- The inclusion criteria were patients aged 18-60 years
- ASA 1-2 who would undergo non-digestive elective surgery in Cipto Mangunkusumo Hospital
- Body mass index between 20-30 kg/m2
Who cannot join
- patient who is not willing to enter the study
- patients with diabetes mellitus
- pregnancy
- abdominal distension
- intestinal motility disorders
- history of dyspepsia
Show all 10Show fewer
- patients who do not receive the standard Cipto Mangunkusumo Hospital diet
- changes of the surgery schedule in which the patient is unable to do 8-hours fasting before surgery
- the patient who has an emergency in the perioperative period
- the patient was unable to consume the standard food provided
Trial locations and contacts
1 site in 1 country.
About this study
Preoperative fasting was a common practice to decrease perioperative aspiration risk. Duration of fasting was proportional to gastric volume. Short fasting duration may increase aspiration risk. However, prolonged perioperative fasting duration may lead to dehydration and hypoglycemia.
The objective of this study was to analyze gastric volume after 6-hour and 8-hour duration of fasting after consumption of solid meal on patients scheduled for elective surgery.
This was a cohort study recruiting 37 subjects from January to February 2019. Subjects were patients scheduled for elective non-digestive surgery in Cipto Mangunkusumo Hospital, Jakarta, Indonesia. Before fasting, all subjects consumed standard Cipto Mangunkusumo meal and was later assessed for gastric volume using ultrasound at 6 and 8 hour after meal was consumed.
Read the detailed description
Background. Preoperative fasting was a common practice to decrease perioperative aspiration risk. Duration of fasting was proportional to gastric volume. Short fasting duration may increase aspiration risk. However, prolonged perioperative fasting duration may lead to dehydration and hypoglycemia. The protocols of 8 hours preoperative fasting was recommended by American Society of Anesthesiologist (ASA) after a full meal. The meal recognized by ASA to make this guidelines were Western diet that contains more fat. South East Asian (SEA) standard solid meal mainly contains rice and less protein and fats. We hypothesized 6-hours compared with 8-hours fasting was sufficient to provide ideal gastric volume for preoperative fasting after SEA standard solid meal. The objective of this study was to analyze gastric volume after 6-hour and 8-hour of fasting after consumption of SEA standard solid meal on patients scheduled for elective surgery.
Methods This was a cohort study recruiting 37 subjects from January to February 2019. Subjects were patients scheduled for elective non-digestive surgery in Cipto Mangunkusumo Hospital, Jakarta, Indonesia. Inclusion criteria were age between 18 to 60 years old, have no nutritional status disorder, and ASA physical status of 1 or 2. The exclusion criteria were patients with diabetes mellitus, pregnancy, abdominal distention, history of dyspepsia, and intestinal motility disturbances.
Subjects agreed to take part in the research, will be initial examined for obtaining demographic data: age, weight and height, type of surgery to be performed, and preoperative examinations. The subject will start 8 hours of fasting before the surgical planning time. Before fasting, the subjects were given Cipto Mangunkusumo Hospital food standardized nutritional levels. Subjects were given 1 hour to consume the food. Six hours after the standard meal is consumed, an ultrasound examination will be performed in the right lateral decubitus position to obtain ultrasound imaging of the antrum. After that, the subject continued fasting until 8 hours after meal and ultrasound examination was performed using the same technique to obtain images of ultrasound imaging of the antrum. Imaging pictures are taken at the time relaxation of the antrum, between two contractions. The results of this imaging are stored and assessments of antrum craniocaudal (CC) and anteroposterior (AP) diameters were performed by research assistants who don't know when the image was taken. These measurements were used to calculate Cross Sectional Area (CSA) using the formula of CSA=(π×CC×AP)/4. The Gastric Volume (GV) was then calculated with the formula GV=27.0+(14.6×CSA)-(1.28×age).
The primary data obtained was the result of repeated examinations. The analysis was adjusted using the Bonferonni correction factor. Categorical data was analyzed using the McNemar test. The results of data processing are displayed in tabular form. The gastric volume was grouped into sufficient and insufficient with a border value of 1.5ml/kg.
- Conditions
- Gastric Volume, Ultrasonography
- Being tested
- Fasting for elective surgery
- Keywords
- Gastric volume, preoperative fasting, ultrasonography.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasting for elective surgeryBehavioural
6-hours and 8-hours fasting before elective surgery
| Study group | Role | What they receive |
|---|---|---|
| 6-hours fasting gastric volume | gastric volume measured after 6-hours fasting Receives: Behavioral: Fasting for elective surgery | |
| 8-hours fasting gastric volume | gastric volume measured after 8-hours fasting Receives: Behavioral: Fasting for elective surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric Volume 6-hours
Gastric volume measured with ultrasound after 6-hours of preoperative fasting
Measured: After 6-hours of preoperative fasting
Gastric Volume 8-hours
Gastric volume measured with ultrasound after 8-hours of preoperative fasting
Measured: After 8-hours of preoperative fasting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start1 Jan 2019
- Primary completion28 Feb 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric VolumeStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raden Besthadi Sukmono, Universitas Indonesia
- Investigators
- Raden B Sukmono, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04875845
- Sponsor's protocol ID
- GVES
- Status last verified
- May 2021
- First submitted
- 21 Apr 2021
- Last updated
- 10 May 2021
- 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 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Gastric Volume After 6-hour and 8-hour Fasting in Patient Scheduled for Elective Surgery
- ClinicalTrials.gov ID
- NCT04875845
- Acronym / sponsor ID
- GVES
- Conditions
- Gastric Volume, Ultrasonography
- Keywords
- Gastric volume, preoperative fasting, ultrasonography.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 6 May 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.
Preoperative fasting was a common practice to decrease perioperative aspiration risk. Duration of fasting was proportional to gastric volume. Short fasting duration may increase aspiration risk. However, prolonged perioperative fasting duration may lead to dehydration and hypoglycemia.
The objective of this study was to analyze gastric volume after 6-hour and 8-hour duration of fasting after consumption of solid meal on patients scheduled for elective surgery.
This was a cohort study recruiting 37 subjects from January to February 2019. Subjects were patients scheduled for elective non-digestive surgery in Cipto Mangunkusumo Hospital, Jakarta, Indonesia. Before fasting, all subjects consumed standard Cipto Mangunkusumo meal and was later assessed for gastric volume using ultrasound at 6 and 8 hour after meal was consumed.
Detailed description
Background. Preoperative fasting was a common practice to decrease perioperative aspiration risk. Duration of fasting was proportional to gastric volume. Short fasting duration may increase aspiration risk. However, prolonged perioperative fasting duration may lead to dehydration and hypoglycemia. The protocols of 8 hours preoperative fasting was recommended by American Society of Anesthesiologist (ASA) after a full meal. The meal recognized by ASA to make this guidelines were Western diet that contains more fat. South East Asian (SEA) standard solid meal mainly contains rice and less protein and fats. We hypothesized 6-hours compared with 8-hours fasting was sufficient to provide ideal gastric volume for preoperative fasting after SEA standard solid meal. The objective of this study was to analyze gastric volume after 6-hour and 8-hour of fasting after consumption of SEA standard solid meal on patients scheduled for elective surgery.
Methods This was a cohort study recruiting 37 subjects from January to February 2019. Subjects were patients scheduled for elective non-digestive surgery in Cipto Mangunkusumo Hospital, Jakarta, Indonesia. Inclusion criteria were age between 18 to 60 years old, have no nutritional status disorder, and ASA physical status of 1 or 2. The exclusion criteria were patients with diabetes mellitus, pregnancy, abdominal distention, history of dyspepsia, and intestinal motility disturbances.
Subjects agreed to take part in the research, will be initial examined for obtaining demographic data: age, weight and height, type of surgery to be performed, and preoperative examinations. The subject will start 8 hours of fasting before the surgical planning time. Before fasting, the subjects were given Cipto Mangunkusumo Hospital food standardized nutritional levels. Subjects were given 1 hour to consume the food. Six hours after the standard meal is consumed, an ultrasound examination will be performed in the right lateral decubitus position to obtain ultrasound imaging of the antrum. After that, the subject continued fasting until 8 hours after meal and ultrasound examination was performed using the same technique to obtain images of ultrasound imaging of the antrum. Imaging pictures are taken at the time relaxation of the antrum, between two contractions. The results of this imaging are stored and assessments of antrum craniocaudal (CC) and anteroposterior (AP) diameters were performed by research assistants who don't know when the image was taken. These measurements were used to calculate Cross Sectional Area (CSA) using the formula of CSA=(π×CC×AP)/4. The Gastric Volume (GV) was then calculated with the formula GV=27.0+(14.6×CSA)-(1.28×age).
The primary data obtained was the result of repeated examinations. The analysis was adjusted using the Bonferonni correction factor. Categorical data was analyzed using the McNemar test. The results of data processing are displayed in tabular form. The gastric volume was grouped into sufficient and insufficient with a border value of 1.5ml/kg.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 6-hours fasting gastric volume | – | Behavioral: Fasting for elective surgerygastric volume measured after 6-hours fasting |
| 8-hours fasting gastric volume | – | Behavioral: Fasting for elective surgerygastric volume measured after 8-hours fasting |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This was a cohort study for 37 subjects from January to February 2019. Subjects were patients scheduled for elective non-digestive surgery in Cipto Mangunkusumo Hospital
Key inclusion criteria (3 listed)
- The inclusion criteria were patients aged 18-60 years
- ASA 1-2 who would undergo non-digestive elective surgery in Cipto Mangunkusumo Hospital
- Body mass index between 20-30 kg/m2
Key exclusion criteria (10 listed)
- patient who is not willing to enter the study
- patients with diabetes mellitus
- pregnancy
- abdominal distension
- intestinal motility disorders
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 |
|---|---|---|
| Fasting for elective surgery6-hours and 8-hours fasting before elective surgery | Behavioural | 6-hours fasting gastric volume, 8-hours fasting gastric volume |
Primary outcome
Gastric Volume 6-hours
Time frame: After 6-hours of preoperative fasting
Gastric volume measured with ultrasound after 6-hours of preoperative fasting
Gastric Volume 8-hours
Time frame: After 8-hours of preoperative fasting
Gastric volume measured with ultrasound after 8-hours of preoperative fasting
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 10 May 2021.
- 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.
Raden B Sukmono principal investigator
Universitas Indonesia
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 Volume and Ultrasonography, run by Universitas Indonesia at 1 site in Indonesia.
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 3 inclusion and 10 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 10 May 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 Indonesia. 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 Volume 6-hours (time frame: After 6-hours of preoperative fasting). The study lists 2 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 10 May 2021.