Gastric EmptyingNCT05333237
Gastric Emptying of High Calorie Liquid Meals
A study testing Intervention #1: ProvideXtra Drink, Intervention #2: Fresubin Energy Drink and Intervention #3: Generic Glucose Solution in people with Gastric Emptying, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Perioperative fasting is an essential patient safety measure to reduce the risk of pulmonary aspiration of gastric contents, a rare but potentially catastrophic complication of anesthetic and airway management. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Emptying
- What is being tested?
- Intervention #1: ProvideXtra Drink, Intervention #2: Fresubin Energy Drink and Intervention #3: Generic Glucose Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteAustria
- Study dates
- 28 Mar 2022to 1 Jun 2022
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA 1 and 2
Who cannot join
- Allergy or intolerance to any of the study products or the ingredients
- Previous esophageal, gastric, or duodeno-pancreatic surgery
- Gastric banding or large hiatal hernia
- mmobility
- Contraindication to right lateral positioning
- Gastrointestinal diseases and disturbances
Show all 9Show fewer
- Participation in another, possibly interfering study
- Diabetes mellitus
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Assessment of Gastric Emptying After a Standardized High Calorie Liquid Meal in Adults: a Prospective Observational Double-blind Study
Perioperative fasting is an essential patient safety measure to reduce the risk of pulmonary aspiration of gastric contents, a rare but potentially catastrophic complication of anesthetic and airway management. Anesthesiologists' concern about aspiration and the increasing awareness towards the negative impact of prolonged restriction of oral intake have shaped the current fasting guidelines. However, due to the perceived safety of prolonged fasting and practical considerations, adoption of the fasting guidelines is suboptimal.
Gastric ultrasound is a quick, non-invasive method to evaluate gastric contents and aspiration risk. Gastric ultrasound can accurately discriminate between solid particles and fluid content, and mathematical models can reliably predict the volume of the gastric contents from the gastric antral area (GAA).
Read more
This project aims to use gastric ultrasound to provide new data that can support management strategies in perioperative patients, that ensure both a low aspiration risk and an adequate nutritional support.
The investigators will test the hypothesis that commercially available liquid meals can be safely used preoperatively. A pilot crossover, study on healthy volunteers will be conducted to determine the gastric emptying time of high-calorie drinks, as compared to clear fluid.
- Conditions
- Gastric Emptying
- Being tested
- Intervention #1: ProvideXtra Drink, Intervention #2: Fresubin Energy Drink, Intervention #3: Generic Glucose Solution
- Keywords
- Preoperative fasting, Liquid meal, Gastric ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention #1: ProvideXtra DrinkDietary supplement
Also called fat-free, high-calorie drink containing hydrolised vegetal protein
Fasted subjects will be offered 200 ml of ProvideXtra and will be asked to ingest it at a comfortable rate. Subsequent gastric ultrasound examinations will be performed half-hourly (up to 6 hours) to determine the volume of the gastric contents. The intervention ends when the stomach appears to be empty again on ultrasound.
Intervention #2: Fresubin Energy DrinkDietary supplement
Also called high-calorie drink without fiber
Fasted subjects will be offered 200 ml of Fresubin Energy Drink and will be asked to ingest it at a comfortable rate. Subsequent gastric ultrasound examinations will be performed half-hourly to determine the volume of the gastric contents. The intervention ends when the stomach appears to be empty again on ultrasound.
Intervention #3: Generic Glucose SolutionDietary supplement
Also called Solution reconstituted form 75 g glucose and 300 ml water
Fasted subjects will be offered the glucose solution and will be asked to ingest it at a comfortable rate. Subsequent gastric ultrasound examinations will be performed half-hourly (up to 6 hours) to determine the volume of the gastric contents. The intervention ends when the stomach appears to be empty again on ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 123 | Experimental | In this study arm the following sequence of interventions will be administered:
upon first study session, intervention #1 will be administered (Dietary Supplement: ProvideXtra Drink).
upon second study session, intervention #2 will be administered (Dietary Supplement: Fresubin Energy Drink).
upon third study session, intervention #3 will be administered (Dietary Supplement: Generic Glucose Solution). Receives: Dietary Supplement: Intervention #1: ProvideXtra Drink; Dietary Supplement: Intervention #2: Fresubin Energy Drink; Dietary Supplement: Intervention #3: Generic Glucose Solution |
| Sequence 132 | Experimental | In this study arm the following sequence of interventions will be administered:
upon first study session, intervention #1 will be administered (Dietary Supplement: ProvideXtra Drink).
upon second study session, intervention #3 will be administered (Dietary Supplement: Generic Glucose Solution).
upon third study session, intervention #2 will be administered (Dietary Supplement: Fresubin Energy Drink). Receives: Dietary Supplement: Intervention #1: ProvideXtra Drink; Dietary Supplement: Intervention #2: Fresubin Energy Drink; Dietary Supplement: Intervention #3: Generic Glucose Solution |
| Sequence 213 | Experimental | In this study arm the following sequence of interventions will be administered:
upon first study session, intervention #2 will be administered (Dietary Supplement: Fresubin Energy Drink).
upon second study session, intervention #1 will be administered (Dietary Supplement: ProvideXtra Drink).
upon third study session, intervention #3 will be administered (Dietary Supplement: Generic Glucose Solution). Receives: Dietary Supplement: Intervention #1: ProvideXtra Drink; Dietary Supplement: Intervention #2: Fresubin Energy Drink; Dietary Supplement: Intervention #3: Generic Glucose Solution |
| Sequence 231 | Experimental | In this study arm the following sequence of interventions will be administered:
upon first study session, intervention #2 will be administered (Dietary Supplement: Fresubin Energy Drink).
upon second study session, intervention #3 will be administered (Dietary Supplement: Fresubin Energy Drink).
upon third study session, intervention #1 will be administered (Dietary Supplement: ProvideXtra Drink). Receives: Dietary Supplement: Intervention #1: ProvideXtra Drink; Dietary Supplement: Intervention #2: Fresubin Energy Drink; Dietary Supplement: Intervention #3: Generic Glucose Solution |
| Sequence 312 | Experimental | In this study arm the following sequence of interventions will be administered:
upon first study session, intervention #3 will be administered (Dietary Supplement: Generic Glucose Solution).
upon second study session, intervention #1 will be administered (Dietary Supplement: ProvideXtra Drink).
upon third study session, intervention #2 will be administered (Dietary Supplement: Fresubin Energy Drink). Receives: Dietary Supplement: Intervention #1: ProvideXtra Drink; Dietary Supplement: Intervention #2: Fresubin Energy Drink; Dietary Supplement: Intervention #3: Generic Glucose Solution |
| Sequence 321 | Experimental | In this study arm the following sequence of interventions will be administered:
upon first study session, intervention #3 will be administered (Dietary Supplement: Generic Glucose Solution).
upon second study session, intervention #2 will be administered (Dietary Supplement: Fresubin Energy Drink).
upon third study session, intervention #1 will be administered (Dietary Supplement: ProvideXtra Drink). Receives: Dietary Supplement: Intervention #1: ProvideXtra Drink; Dietary Supplement: Intervention #2: Fresubin Energy Drink; Dietary Supplement: Intervention #3: Generic Glucose Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric emptying time
Time since ingestion of any of the study products until an empty stomach can be determined on ultrasound
Measured: Repeated ultrasound examinations will be performed every 30 minutes after the ingestion of the study product up to 6 hours after ingestion to determine whether the stomach has completely emptied.
Secondary outcomes (1)
Gastric volume at prespecified intervals after ingestions
The volume of the gastric content determined using ultrasound
Measured: Ultrasound examinations will be repeated every 30 minutes after the ingestion of the study product up to 6 hours and the gastric antrum area and the gastric antrum cross-sectional area will be measured to estimate the volume of the gastric content.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start28 Mar 2022
- Primary completion18 May 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gastric EmptyingStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 3 interventions will be administered in fasted healthy volunteers in a random sequence on 3 different days.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Razvan Bologheanu, Medical University of Vienna
- Investigators
- Andreas Duma, MSc, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05333237
- Sponsor's protocol ID
- 1700_2021
- Status last verified
- Aug 2022
- First submitted
- 28 Mar 2022
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be accessed by the PI upon request.
Publications
Smith I, Kranke P, Murat I, Smith A, O'Sullivan G, Soreide E, Spies C, in't Veld B; European Society of Anaesthesiology. Perioperative fasting in adults and children: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2011 Aug;28(8):556-69. doi: 10.1097/EJA.0b013e3283495ba1.
PubMed 21712716Tacken MCT, van Leest TAJ, van de Putte P, Keijzer C, Perlas A. Ultrasound assessment of gastric volumes of thick fluids: Validating a prediction model. Eur J Anaesthesiol. 2021 Dec 1;38(12):1223-1229. doi: 10.1097/EJA.0000000000001465.
PubMed 33606419Perlas A, Mitsakakis N, Liu L, Cino M, Haldipur N, Davis L, Cubillos J, Chan V. Validation of a mathematical model for ultrasound assessment of gastric volume by gastroscopic examination. Anesth Analg. 2013 Feb;116(2):357-63. doi: 10.1213/ANE.0b013e318274fc19. Epub 2013 Jan 9.
PubMed 23302981Perlas A, Arzola C, Van de Putte P. Point-of-care gastric ultrasound and aspiration risk assessment: a narrative review. Can J Anaesth. 2018 Apr;65(4):437-448. doi: 10.1007/s12630-017-1031-9. Epub 2017 Dec 11.
PubMed 29230709Van de Putte P, Perlas A. Ultrasound assessment of gastric content and volume. Br J Anaesth. 2014 Jul;113(1):12-22. doi: 10.1093/bja/aeu151. Epub 2014 Jun 3.
PubMed 24893784
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Assessment of Gastric Emptying After a Standardized High Calorie Liquid Meal in Adults: a Prospective Observational Double-blind Study
- ClinicalTrials.gov ID
- NCT05333237
- Acronym / sponsor ID
- 1700_2021
- Conditions
- Gastric Emptying
- Keywords
- Preoperative fasting, Liquid meal, Gastric ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 18 May 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 18 Apr 2022 (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.
Perioperative fasting is an essential patient safety measure to reduce the risk of pulmonary aspiration of gastric contents, a rare but potentially catastrophic complication of anesthetic and airway management. Anesthesiologists' concern about aspiration and the increasing awareness towards the negative impact of prolonged restriction of oral intake have shaped the current fasting guidelines. However, due to the perceived safety of prolonged fasting and practical considerations, adoption of the fasting guidelines is suboptimal.
Gastric ultrasound is a quick, non-invasive method to evaluate gastric contents and aspiration risk. Gastric ultrasound can accurately discriminate between solid particles and fluid content, and mathematical models can reliably predict the volume of the gastric contents from the gastric antral area (GAA).
This project aims to use gastric ultrasound to provide new data that can support management strategies in perioperative patients, that ensure both a low aspiration risk and an adequate nutritional support.
The investigators will test the hypothesis that commercially available liquid meals can be safely used preoperatively. A pilot crossover, study on healthy volunteers will be conducted to determine the gastric emptying time of high-calorie drinks, as compared to clear fluid.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- 3 interventions will be administered in fasted healthy volunteers in a random sequence on 3 different days.
| Arm | Type | Receives |
|---|---|---|
| Sequence 123 | Experimental | Dietary Supplement: Intervention #1: ProvideXtra Drink, Dietary Supplement: Intervention #2: Fresubin Energy Drink, Dietary Supplement: Intervention #3: Generic Glucose SolutionIn this study arm the following sequence of interventions will be administered: upon first study session, intervention #1 will be administered (Dietary Supplement: ProvideXtra Drink). upon second study session, intervention #2 will be administered (Dietary Supplement: Fresubin Energy Drink). upon third study session, intervention #3 will be administered (Dietary Supplement: Generic Glucose Solution). |
| Sequence 132 | Experimental | Dietary Supplement: Intervention #1: ProvideXtra Drink, Dietary Supplement: Intervention #2: Fresubin Energy Drink, Dietary Supplement: Intervention #3: Generic Glucose SolutionIn this study arm the following sequence of interventions will be administered: upon first study session, intervention #1 will be administered (Dietary Supplement: ProvideXtra Drink). upon second study session, intervention #3 will be administered (Dietary Supplement: Generic Glucose Solution). upon third study session, intervention #2 will be administered (Dietary Supplement: Fresubin Energy Drink). |
| Sequence 213 | Experimental | Dietary Supplement: Intervention #1: ProvideXtra Drink, Dietary Supplement: Intervention #2: Fresubin Energy Drink, Dietary Supplement: Intervention #3: Generic Glucose SolutionIn this study arm the following sequence of interventions will be administered: upon first study session, intervention #2 will be administered (Dietary Supplement: Fresubin Energy Drink). upon second study session, intervention #1 will be administered (Dietary Supplement: ProvideXtra Drink). upon third study session, intervention #3 will be administered (Dietary Supplement: Generic Glucose Solution). |
| Sequence 231 | Experimental | Dietary Supplement: Intervention #1: ProvideXtra Drink, Dietary Supplement: Intervention #2: Fresubin Energy Drink, Dietary Supplement: Intervention #3: Generic Glucose SolutionIn this study arm the following sequence of interventions will be administered: upon first study session, intervention #2 will be administered (Dietary Supplement: Fresubin Energy Drink). upon second study session, intervention #3 will be administered (Dietary Supplement: Fresubin Energy Drink). upon third study session, intervention #1 will be administered (Dietary Supplement: ProvideXtra Drink). |
| Sequence 312 | Experimental | Dietary Supplement: Intervention #1: ProvideXtra Drink, Dietary Supplement: Intervention #2: Fresubin Energy Drink, Dietary Supplement: Intervention #3: Generic Glucose SolutionIn this study arm the following sequence of interventions will be administered: upon first study session, intervention #3 will be administered (Dietary Supplement: Generic Glucose Solution). upon second study session, intervention #1 will be administered (Dietary Supplement: ProvideXtra Drink). upon third study session, intervention #2 will be administered (Dietary Supplement: Fresubin Energy Drink). |
| Sequence 321 | Experimental | Dietary Supplement: Intervention #1: ProvideXtra Drink, Dietary Supplement: Intervention #2: Fresubin Energy Drink, Dietary Supplement: Intervention #3: Generic Glucose SolutionIn this study arm the following sequence of interventions will be administered: upon first study session, intervention #3 will be administered (Dietary Supplement: Generic Glucose Solution). upon second study session, intervention #2 will be administered (Dietary Supplement: Fresubin Energy Drink). upon third study session, intervention #1 will be administered (Dietary Supplement: ProvideXtra Drink). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA 1 and 2
Key exclusion criteria (9 listed)
- Allergy or intolerance to any of the study products or the ingredients
- Previous esophageal, gastric, or duodeno-pancreatic surgery
- Gastric banding or large hiatal hernia
- mmobility
- Contraindication to right lateral positioning
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 |
|---|---|---|
| Intervention #1: ProvideXtra DrinkAlso: fat-free, high-calorie drink containing hydrolised vegetal proteinFasted subjects will be offered 200 ml of ProvideXtra and will be asked to ingest it at a comfortable rate. Subsequent gastric ultrasound examinations will be performed half-hourly (up to 6 hours) to determine the volume of the gastric contents. The intervention ends when the stomach appears to be empty again on ultrasound. | Dietary supplement | Sequence 123, Sequence 132, Sequence 213, Sequence 231, Sequence 312, Sequence 321 |
| Intervention #2: Fresubin Energy DrinkAlso: high-calorie drink without fiberFasted subjects will be offered 200 ml of Fresubin Energy Drink and will be asked to ingest it at a comfortable rate. Subsequent gastric ultrasound examinations will be performed half-hourly to determine the volume of the gastric contents. The intervention ends when the stomach appears to be empty again on ultrasound. | Dietary supplement | Sequence 123, Sequence 132, Sequence 213, Sequence 231, Sequence 312, Sequence 321 |
| Intervention #3: Generic Glucose SolutionAlso: Solution reconstituted form 75 g glucose and 300 ml waterFasted subjects will be offered the glucose solution and will be asked to ingest it at a comfortable rate. Subsequent gastric ultrasound examinations will be performed half-hourly (up to 6 hours) to determine the volume of the gastric contents. The intervention ends when the stomach appears to be empty again on ultrasound. | Dietary supplement | Sequence 123, Sequence 132, Sequence 213, Sequence 231, Sequence 312, Sequence 321 |
Primary outcome
Gastric emptying time
Time frame: Repeated ultrasound examinations will be performed every 30 minutes after the ingestion of the study product up to 6 hours after ingestion to determine whether the stomach has completely emptied.
Time since ingestion of any of the study products until an empty stomach can be determined on ultrasound
1 secondary outcome
Gastric volume at prespecified intervals after ingestions
Time frame: Ultrasound examinations will be repeated every 30 minutes after the ingestion of the study product up to 6 hours and the gastric antrum area and the gastric antrum cross-sectional area will be measured to estimate the volume of the gastric content.
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 12 Aug 2022.
- Background: PubMed 21712716Smith I, Kranke P, Murat I, Smith A, O'Sullivan G, Soreide E, Spies C, in't Veld B; European Society of Anaesthesiology. Perioperative fasting in adults and children: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2011 Aug;28(8):556-69. doi: 10.1097/EJA.0b013e3283495ba1.
- Background: PubMed 33606419Tacken MCT, van Leest TAJ, van de Putte P, Keijzer C, Perlas A. Ultrasound assessment of gastric volumes of thick fluids: Validating a prediction model. Eur J Anaesthesiol. 2021 Dec 1;38(12):1223-1229. doi: 10.1097/EJA.0000000000001465.
- Background: PubMed 23302981Perlas A, Mitsakakis N, Liu L, Cino M, Haldipur N, Davis L, Cubillos J, Chan V. Validation of a mathematical model for ultrasound assessment of gastric volume by gastroscopic examination. Anesth Analg. 2013 Feb;116(2):357-63. doi: 10.1213/ANE.0b013e318274fc19. Epub 2013 Jan 9.
- Background: PubMed 29230709Perlas A, Arzola C, Van de Putte P. Point-of-care gastric ultrasound and aspiration risk assessment: a narrative review. Can J Anaesth. 2018 Apr;65(4):437-448. doi: 10.1007/s12630-017-1031-9. Epub 2017 Dec 11.
- Background: PubMed 24893784Van de Putte P, Perlas A. Ultrasound assessment of gastric content and volume. Br J Anaesth. 2014 Jul;113(1):12-22. doi: 10.1093/bja/aeu151. Epub 2014 Jun 3.
- Individual participant dataSharing planned: Yes. IPD will be accessed by the PI upon 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.
Andreas Duma, MSc principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention #1: ProvideXtra Drink, Intervention #2: Fresubin Energy Drink and Intervention #3: Generic Glucose Solution in people with Gastric Emptying, run by Medical University of Vienna at 1 site in Austria.
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 9 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 12 Aug 2022. 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 Austria. 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 emptying time (time frame: Repeated ultrasound examinations will be performed every 30 minutes after the ingestion of the study product up to 6 hours after ingestion to determine whether the stomach has completely emptied.). 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 NCT05333237, which also lists 5 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 12 Aug 2022.