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Completed

NCT Number: NCT05333237

Gastric Emptying of High Calorie Liquid Meals

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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Key information

Conditions

Gastric Emptying

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: fat-free, high-calorie drink containing hydrolised vegetal protein

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.

Other names: high-calorie drink without fiber

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.

Other names: Solution reconstituted form 75 g glucose and 300 ml water

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

    The volume of the gastric content determined using ultrasound

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 18, 2022
Registry last updated
Aug 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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