Skip to main content
Clinical Trials/NCT05333237
NCT05333237CompletedNot Applicable

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

Medical University of Vienna2 sites in 1 country25 target enrollmentStarted: March 28, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
25
Locations
2
Primary Endpoint
Gastric emptying time

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Other
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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

  • 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.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Razvan Bologheanu

Principal Investigator

Medical University of Vienna

Study Sites (2)

Loading locations...

Similar Trials