Gastric Emptying of High Calorie Liquid Meals

Not Applicable

Completed

• Conditions: Gastric Emptying

• Registration Number: NCT05333237
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-28
• Study First Submitted: 2022-03-28
• Study First Submitted QC: 2022-04-13
• Study First Posted: 2022-04-18
• Primary Completion: 2022-05-18
• Study Completion: 2022-06-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-11
• Last Update Posted: 2022-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• ASA 1 and 2

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Gastric emptying time	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 Outcome Measures

Name	Time	Method
Gastric volume at prespecified intervals after ingestions	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

Trial Locations

Locations (1)

Medical University Vienna; 🇦🇹 Vienna, Austria