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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2 months study duration

First Submitted

Initial submission to the registry

March 28, 2022

Completed

Same day until next milestone

Study Start

First participant enrolled

March 28, 2022

Completed

21 days until next milestone

First Posted

Study publicly available on registry

April 18, 2022

Completed

1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2022

Completed

14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed

Last Updated

August 12, 2022

Status Verified

August 1, 2022

Enrollment Period

2 months

First QC Date

March 28, 2022

Last Update Submit

August 11, 2022

Conditions

Gastric Emptying

Keywords

Preoperative fastingLiquid mealGastric ultrasound

Outcome Measures

Primary Outcomes (1)

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.

Secondary Outcomes (1)

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.

Study Arms (6)

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).