Clinical trial NCT05333237: Gastric Emptying of High Calorie Liquid Meals
Official title: Ultrasound Assessment of Gastric Emptying After a Standardized High Calorie Liquid Meal in Adults: a Prospective Observational Double-blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Emptying
Keywords: Preoperative fasting
Liquid meal
Gastric ultrasound
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2022-04-18
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 3 interventions will be administered in fasted healthy volunteers in a random sequence on 3 different days.
Primary purpose: OTHER

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Gastric emptying time
timeFrame: 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:
measure: Gastric volume at prespecified intervals after ingestions
timeFrame: 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.
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna
Study officials:
affiliation: Medical University of Vienna
name: Andreas Duma, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.