Gastric Emptying of High Calorie Liquid Meals

Study Overview
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Brief Summary
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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.

Official Title
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Ultrasound Assessment of Gastric Emptying After a Standardized High Calorie Liquid Meal in Adults: a Prospective Observational Double-blind Study

Conditions
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Gastric Emptying

Intervention / Treatment
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* Dietary Supplement: Intervention #1: ProvideXtra Drink
* Dietary Supplement: Intervention #2: Fresubin Energy Drink
* Dietary Supplement: Intervention #3: Generic Glucose Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA 1 and 2 Exclusion Criteria: 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 Participation in another, possibly interfering study Diabetes mellitus Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 3 interventions will be administered in fasted healthy volunteers in a random sequence on 3 different days.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 123<br>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). | Dietary Supplement: Intervention #1: ProvideXtra Drink<br>* 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.<br>* Other names: fat-free, high-calorie drink containing hydrolised vegetal protein;Dietary Supplement: Intervention #2: Fresubin Energy Drink<br>* 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.<br>* Other names: high-calorie drink without fiber;Dietary Supplement: Intervention #3: Generic Glucose Solution<br>* 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.<br>* Other names: Solution reconstituted form 75 g glucose and 300 ml water;|
| Experimental: Sequence 132<br>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). | Dietary Supplement: Intervention #1: ProvideXtra Drink<br>* 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.<br>* Other names: fat-free, high-calorie drink containing hydrolised vegetal protein;Dietary Supplement: Intervention #2: Fresubin Energy Drink<br>* 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.<br>* Other names: high-calorie drink without fiber;Dietary Supplement: Intervention #3: Generic Glucose Solution<br>* 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.<br>* Other names: Solution reconstituted form 75 g glucose and 300 ml water;|
| Experimental: Sequence 213<br>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). | Dietary Supplement: Intervention #1: ProvideXtra Drink<br>* 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.<br>* Other names: fat-free, high-calorie drink containing hydrolised vegetal protein;Dietary Supplement: Intervention #2: Fresubin Energy Drink<br>* 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.<br>* Other names: high-calorie drink without fiber;Dietary Supplement: Intervention #3: Generic Glucose Solution<br>* 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.<br>* Other names: Solution reconstituted form 75 g glucose and 300 ml water;|
| Experimental: Sequence 231<br>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). | Dietary Supplement: Intervention #1: ProvideXtra Drink<br>* 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.<br>* Other names: fat-free, high-calorie drink containing hydrolised vegetal protein;Dietary Supplement: Intervention #2: Fresubin Energy Drink<br>* 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.<br>* Other names: high-calorie drink without fiber;Dietary Supplement: Intervention #3: Generic Glucose Solution<br>* 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.<br>* Other names: Solution reconstituted form 75 g glucose and 300 ml water;|
| Experimental: Sequence 312<br>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). | Dietary Supplement: Intervention #1: ProvideXtra Drink<br>* 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.<br>* Other names: fat-free, high-calorie drink containing hydrolised vegetal protein;Dietary Supplement: Intervention #2: Fresubin Energy Drink<br>* 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.<br>* Other names: high-calorie drink without fiber;Dietary Supplement: Intervention #3: Generic Glucose Solution<br>* 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.<br>* Other names: Solution reconstituted form 75 g glucose and 300 ml water;|
| Experimental: Sequence 321<br>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). | Dietary Supplement: Intervention #1: ProvideXtra Drink<br>* 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.<br>* Other names: fat-free, high-calorie drink containing hydrolised vegetal protein;Dietary Supplement: Intervention #2: Fresubin Energy Drink<br>* 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.<br>* Other names: high-calorie drink without fiber;Dietary Supplement: Intervention #3: Generic Glucose Solution<br>* 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.<br>* Other names: Solution reconstituted form 75 g glucose and 300 ml water;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric emptying time | Time since ingestion of any of the study products until an empty stomach can be determined on ultrasound | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric volume at prespecified intervals after ingestions | The volume of the gastric content determined using ultrasound | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preoperative fasting, Liquid meal, Gastric ultrasound