Healthy ParticipantsNCT04478435
Gastric Volume Estimation by Ultrasonography After Glucose Loaded Clear Fluid Ingestion in Fasted Adult
A study testing glucose loaded clear fluid in people with Healthy Participants, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
Trial summary
Introduction; Pre operative gastric ultrasonography is a newly developed tool used to evaluate gastric content and volume in assessing perioperative aspiration risk and guide anaesthetic management. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- glucose loaded clear fluid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 254 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jan 2019to 1 Jul 2019
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA 1 \& 2
Who cannot join
- Upper gastrointestinal pathology such as hiatus hernia, oesophageal cancer
- Prior surgery to upper GI
- On medication that may affect gastric emptying time
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Pusat Perubatan Universiti Kebangsaan Malaysia
Kuala Lumpur, Wp, 5600
About this study
Official title: The Comparative Gastric Volume Estimation Between Different Time Intervals by Ultrasonography After Glucose Loaded Clear Fluid Ingestion in Fasted Healthy Adult
Introduction; Pre operative gastric ultrasonography is a newly developed tool used to evaluate gastric content and volume in assessing perioperative aspiration risk and guide anaesthetic management. Gastric antrum is the most amenable and most consistently identified region for sonographic examination during assessment even in empty state. Baseline gastric secretions and clear fluids i.e: water, apple juice and tea have hypoechoeic or anechoic appearance, whilst milk, thick fluids, or suspensions will have increased echogenicity. Evaluation with sonographic assessment were found to be accurately reflective of gastric content in various studies.
In this study, healthy volunteers were recruited. They will be required to fast at least 8 hours prior to baseline gastric antrum ultrasonography assessment. Following that, they will require to drink 250ml glucose loaded drinks. Repeated Ultrasound assessment will be done after 1 hour of glucose loaded drink ingestion in Group 1 and after 2 hours in Group 2. Hypothesis of the study is there will be no significant different between ultrasound assessment between this 2 groups.
Read the detailed description
This prospective randomized controlled trial study will be conducted in the Department of Anaesthesiology and Intensive Care UKM for eight months period from November 2018 to June 2019 involving healthy adult volunteers comprising staff members of Department of Anaesthesiology and Intensive Care, after obtaining approval from Research Committee of the Department of Anaesthesiology \& Intensive Care, Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia Medical Centre (UKMMC) and the Medical Research \& Ethics Committee, UKMMC. Written informed consent will be obtained from volunteers who fulfill the inclusion criteria.
All volunteers will be fasted, a minimum of 8 hours (duration of fasting will be recorded before the study begin) and will undergo baseline ultrasonographic gastric assessment (t0).
All subjects in Group 1 and group 2 will drink 250 ml of lychee juice (glucose loaded clear fluid containing solution with lychee flavor; 145 kcal in 250 ml) after completion of baseline gastric assessment.
Group 1 subjects will then continue fasting for one hour until completion of second sonographic antral assessment. Subjects in Group 2 will continue fasting for 2 hours until second sonographic antral assessment scan is completed.
Subjects will be divided into 2 groups via computer randomization which will be allocated by anaesthesia trainee that will not be taking part in the analytical and further write up phases of the study. Ultrasonographic volume assessment will be conducted by a single operator who is an anaesthesia Masters trainee, experienced in diagnostic abdominal ultrasound with more than 20 sonographic gastric volume assessments. The images will be recorded and validated by a consultant radiologist.
Ultrasonographic views of antral area will be obtained using a curvilinear array 2- to 5-MHz transducer and a Mindray DC-70 (Shanghai, China) with image compounding technologies. Images will be obtained with the stomach at rest, and between peristaltic contractions. Sonograms of the antral area will be examined in 2 views, cross-section in the supine position, followed by the right lateral decubitus position, at each of the two scanning sessions.
During ultrasonography, the antrum will be imaged in a parasagittal plane in the epigastric area using the left lobe of the liver, the inferior vena cava, and the superior mesenteric vein as internal landmarks. The two vessels are usually visualized slightly to the right of the abdominal midline. Once these vessels were identified, the transducer will be rotated slightly clockwise or counterclockwise to best obtain a true cross-sectional view of the antrum. The anteroposterior and craniocaudal diameters will be measured in this view.
CSA of the antral area (a two-dimensional section) will be calculated according to the formula previously used by Bolondi18 using two maximum perpendicular diameters.
This formula essentially represents the surface area of an ellipse, as follows: CSA (AP x CC x pie/4), where AP is the anteroposterior diameter and CC is the craniocaudal diameter measures in one decimal point.
Estimation of gastric volume will be obtain using this formula:
Predicted gastric volume based on right lateral CSA value : 27 + 14.6 * right lat CSA - 1.28*age (negative volume value indicates and empty state).
- Conditions
- Healthy Participants
- Being tested
- glucose loaded clear fluid
- Keywords
- gastric antrum ultrasonography, Gastric volume estimation, aspiration risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glucose loaded clear fluidOther
Ultrasound assessment of gastric antrum is done at different time interval following glucose loaded clear fluid ingestion
| Study group | Role | What they receive |
|---|---|---|
| 1 Hour post intervention | Active comparator | Ultrasound assessment done 1 hour after ingestion of glucose loaded drink Receives: Other: glucose loaded clear fluid |
| 2 hours post intervention | Placebo comparator | Ultrasound assessment done 2 hour after ingestion of glucose loaded drink Receives: Other: glucose loaded clear fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric volume assessment
Gastric volume can be calculated with gastric antrum measurement
Measured: 1 hour after intervention
Gastric volume assessment
Gastric volume can be calculated with gastric antrum measurement
Measured: 2 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start1 Jan 2019
- Primary completion1 Jun 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Healthy ParticipantsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Syarifah Noor Nazihah S Masri, Principal investigator, PPUKM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04478435
- Sponsor's protocol ID
- FF-2018-447
- Status last verified
- Jul 2020
- First submitted
- 5 Jul 2020
- Last updated
- 20 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be share on request
Publications
Warner MA, Warner ME, Weber JG. Clinical significance of pulmonary aspiration during the perioperative period. Anesthesiology. 1993 Jan;78(1):56-62. doi: 10.1097/00000542-199301000-00010.
PubMed 8424572Read MS, Vaughan RS. Allowing pre-operative patients to drink: effects on patients' safety and comfort of unlimited oral water until 2 hours before anaesthesia. Acta Anaesthesiol Scand. 1991 Oct;35(7):591-5. doi: 10.1111/j.1399-6576.1991.tb03354.x.
PubMed 1785235Perlas A, Davis L, Khan M, Mitsakakis N, Chan VW. Gastric sonography in the fasted surgical patient: a prospective descriptive study. Anesth Analg. 2011 Jul;113(1):93-7. doi: 10.1213/ANE.0b013e31821b98c0. Epub 2011 May 19.
PubMed 21596885Kruisselbrink R, Gharapetian A, Chaparro LE, Ami N, Richler D, Chan VWS, Perlas A. Diagnostic Accuracy of Point-of-Care Gastric Ultrasound. Anesth Analg. 2019 Jan;128(1):89-95. doi: 10.1213/ANE.0000000000003372.
PubMed 29624530
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparative Gastric Volume Estimation Between Different Time Intervals by Ultrasonography After Glucose Loaded Clear Fluid Ingestion in Fasted Healthy Adult
- ClinicalTrials.gov ID
- NCT04478435
- Acronym / sponsor ID
- FF-2018-447
- Conditions
- Healthy Participants
- Keywords
- gastric antrum ultrasonography, Gastric volume estimation, aspiration risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical CentreUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 20 Jul 2020 (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.
Introduction; Pre operative gastric ultrasonography is a newly developed tool used to evaluate gastric content and volume in assessing perioperative aspiration risk and guide anaesthetic management. Gastric antrum is the most amenable and most consistently identified region for sonographic examination during assessment even in empty state. Baseline gastric secretions and clear fluids i.e: water, apple juice and tea have hypoechoeic or anechoic appearance, whilst milk, thick fluids, or suspensions will have increased echogenicity. Evaluation with sonographic assessment were found to be accurately reflective of gastric content in various studies.
In this study, healthy volunteers were recruited. They will be required to fast at least 8 hours prior to baseline gastric antrum ultrasonography assessment. Following that, they will require to drink 250ml glucose loaded drinks. Repeated Ultrasound assessment will be done after 1 hour of glucose loaded drink ingestion in Group 1 and after 2 hours in Group 2. Hypothesis of the study is there will be no significant different between ultrasound assessment between this 2 groups.
Detailed description
This prospective randomized controlled trial study will be conducted in the Department of Anaesthesiology and Intensive Care UKM for eight months period from November 2018 to June 2019 involving healthy adult volunteers comprising staff members of Department of Anaesthesiology and Intensive Care, after obtaining approval from Research Committee of the Department of Anaesthesiology \& Intensive Care, Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia Medical Centre (UKMMC) and the Medical Research \& Ethics Committee, UKMMC. Written informed consent will be obtained from volunteers who fulfill the inclusion criteria.
All volunteers will be fasted, a minimum of 8 hours (duration of fasting will be recorded before the study begin) and will undergo baseline ultrasonographic gastric assessment (t0).
All subjects in Group 1 and group 2 will drink 250 ml of lychee juice (glucose loaded clear fluid containing solution with lychee flavor; 145 kcal in 250 ml) after completion of baseline gastric assessment.
Group 1 subjects will then continue fasting for one hour until completion of second sonographic antral assessment. Subjects in Group 2 will continue fasting for 2 hours until second sonographic antral assessment scan is completed.
Subjects will be divided into 2 groups via computer randomization which will be allocated by anaesthesia trainee that will not be taking part in the analytical and further write up phases of the study. Ultrasonographic volume assessment will be conducted by a single operator who is an anaesthesia Masters trainee, experienced in diagnostic abdominal ultrasound with more than 20 sonographic gastric volume assessments. The images will be recorded and validated by a consultant radiologist.
Ultrasonographic views of antral area will be obtained using a curvilinear array 2- to 5-MHz transducer and a Mindray DC-70 (Shanghai, China) with image compounding technologies. Images will be obtained with the stomach at rest, and between peristaltic contractions. Sonograms of the antral area will be examined in 2 views, cross-section in the supine position, followed by the right lateral decubitus position, at each of the two scanning sessions.
During ultrasonography, the antrum will be imaged in a parasagittal plane in the epigastric area using the left lobe of the liver, the inferior vena cava, and the superior mesenteric vein as internal landmarks. The two vessels are usually visualized slightly to the right of the abdominal midline. Once these vessels were identified, the transducer will be rotated slightly clockwise or counterclockwise to best obtain a true cross-sectional view of the antrum. The anteroposterior and craniocaudal diameters will be measured in this view.
CSA of the antral area (a two-dimensional section) will be calculated according to the formula previously used by Bolondi18 using two maximum perpendicular diameters.
This formula essentially represents the surface area of an ellipse, as follows: CSA (AP x CC x pie/4), where AP is the anteroposterior diameter and CC is the craniocaudal diameter measures in one decimal point.
Estimation of gastric volume will be obtain using this formula:
Predicted gastric volume based on right lateral CSA value : 27 + 14.6 * right lat CSA - 1.28*age (negative volume value indicates and empty state).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Hour post intervention | Active comparator | Other: glucose loaded clear fluidUltrasound assessment done 1 hour after ingestion of glucose loaded drink |
| 2 hours post intervention | Placebo comparator | Other: glucose loaded clear fluidUltrasound assessment done 2 hour after ingestion of glucose loaded drink |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA 1 \& 2
Key exclusion criteria (4 listed)
- Upper gastrointestinal pathology such as hiatus hernia, oesophageal cancer
- Prior surgery to upper GI
- On medication that may affect gastric emptying time
- 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 |
|---|---|---|
| glucose loaded clear fluidUltrasound assessment of gastric antrum is done at different time interval following glucose loaded clear fluid ingestion | Other | 1 Hour post intervention, 2 hours post intervention |
Primary outcome
Gastric volume assessment
Time frame: 1 hour after intervention
Gastric volume can be calculated with gastric antrum measurement
Gastric volume assessment
Time frame: 2 hours after intervention
Gastric volume can be calculated with gastric antrum measurement
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 20 Jul 2020.
- Results publication: PubMed 8424572Warner MA, Warner ME, Weber JG. Clinical significance of pulmonary aspiration during the perioperative period. Anesthesiology. 1993 Jan;78(1):56-62. doi: 10.1097/00000542-199301000-00010.
- Results publication: PubMed 1785235Read MS, Vaughan RS. Allowing pre-operative patients to drink: effects on patients' safety and comfort of unlimited oral water until 2 hours before anaesthesia. Acta Anaesthesiol Scand. 1991 Oct;35(7):591-5. doi: 10.1111/j.1399-6576.1991.tb03354.x.
- Results publication: PubMed 21596885Perlas A, Davis L, Khan M, Mitsakakis N, Chan VW. Gastric sonography in the fasted surgical patient: a prospective descriptive study. Anesth Analg. 2011 Jul;113(1):93-7. doi: 10.1213/ANE.0b013e31821b98c0. Epub 2011 May 19.
- Results publication: PubMed 29624530Kruisselbrink R, Gharapetian A, Chaparro LE, Ami N, Richler D, Chan VWS, Perlas A. Diagnostic Accuracy of Point-of-Care Gastric Ultrasound. Anesth Analg. 2019 Jan;128(1):89-95. doi: 10.1213/ANE.0000000000003372.
- Individual participant dataSharing planned: No. IPD will be share on request
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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.
Syarifah Noor Nazihah S Masri principal investigator
PPUKM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing glucose loaded clear fluid in people with Healthy Participants, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
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 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: finished, as of the sponsor's last update on 20 Jul 2020. 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 Malaysia. 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. Some participants in this study may receive a placebo. 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 assessment (time frame: 1 hour after intervention). 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?
On the ClinicalTrials.gov record for NCT04478435, which also lists 4 linked publications.
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 20 Jul 2020.