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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention #1: ProvideXtra Drink | Dietary Supplement | 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Duma, MSc | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Vienna | Vienna | 1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21712716 | Background | 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. | |
| 33606419 | Background |
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IPD will be accessed by the PI upon request.
Data will be available from the PI 10 years after study completion.
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| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| D005947 | Glucose |
| D014867 | Water |
| ID | Term |
|---|---|
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
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3 interventions will be administered in fasted healthy volunteers in a random sequence on 3 different days.
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| 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). |
|
| 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). |
|
| 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). |
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| Intervention #2: Fresubin Energy Drink | Dietary Supplement | 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. |
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| Intervention #3: Generic Glucose Solution | Dietary Supplement | 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. |
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| Tacken 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. |
| 23302981 | Background | Perlas 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. |
| 29230709 | Background | Perlas 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. |
| 24893784 | Background | Van 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. |
| D010829 |
| Physiological Phenomena |
| D019602 | Food and Beverages |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |