Gastric Emptying of High Calorie Liquid Meals

Medical University of Vienna

Status: Completed

Conditions: Gastric Emptying

Treatments: Dietary Supplement: Intervention #3: Generic Glucose Solution; Dietary Supplement: Intervention #1: ProvideXtra Drink; Dietary Supplement: Intervention #2: Fresubin Energy Drink

Study type: Interventional

Funder types: Other

Identifiers

NCT05333237

1700_2021

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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25 participants in 6 patient groups

Sequence 123

Experimental group

Description:

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).

Treatment:

Dietary Supplement: Intervention #2: Fresubin Energy Drink

Dietary Supplement: Intervention #3: Generic Glucose Solution

Dietary Supplement: Intervention #1: ProvideXtra Drink

Sequence 132

Experimental group

Description:

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 #3 will be administered (Dietary Supplement: Generic Glucose Solution). upon third study session, intervention #2 will be administered (Dietary Supplement: Fresubin Energy Drink).

Treatment:

Dietary Supplement: Intervention #2: Fresubin Energy Drink

Dietary Supplement: Intervention #3: Generic Glucose Solution

Dietary Supplement: Intervention #1: ProvideXtra Drink

Sequence 213

Experimental group

Description:

In this study arm the following sequence of interventions will be administered: upon first study session, intervention #2 will be administered (Dietary Supplement: Fresubin Energy Drink). upon second study session, intervention #1 will be administered (Dietary Supplement: ProvideXtra Drink). upon third study session, intervention #3 will be administered (Dietary Supplement: Generic Glucose Solution).

Treatment:

Dietary Supplement: Intervention #2: Fresubin Energy Drink

Dietary Supplement: Intervention #3: Generic Glucose Solution

Dietary Supplement: Intervention #1: ProvideXtra Drink

Sequence 231

Experimental group

Description:

In this study arm the following sequence of interventions will be administered: upon first study session, intervention #2 will be administered (Dietary Supplement: Fresubin Energy Drink). upon second study session, intervention #3 will be administered (Dietary Supplement: Fresubin Energy Drink). upon third study session, intervention #1 will be administered (Dietary Supplement: ProvideXtra Drink).

Treatment:

Dietary Supplement: Intervention #2: Fresubin Energy Drink

Dietary Supplement: Intervention #3: Generic Glucose Solution

Dietary Supplement: Intervention #1: ProvideXtra Drink

Sequence 312

Experimental group

Description:

In this study arm the following sequence of interventions will be administered: upon first study session, intervention #3 will be administered (Dietary Supplement: Generic Glucose Solution). upon second study session, intervention #1 will be administered (Dietary Supplement: ProvideXtra Drink). upon third study session, intervention #2 will be administered (Dietary Supplement: Fresubin Energy Drink).

Treatment:

Dietary Supplement: Intervention #2: Fresubin Energy Drink

Dietary Supplement: Intervention #3: Generic Glucose Solution

Dietary Supplement: Intervention #1: ProvideXtra Drink

Sequence 321

Experimental group

Description:

In this study arm the following sequence of interventions will be administered: upon first study session, intervention #3 will be administered (Dietary Supplement: Generic Glucose Solution). upon second study session, intervention #2 will be administered (Dietary Supplement: Fresubin Energy Drink). upon third study session, intervention #1 will be administered (Dietary Supplement: ProvideXtra Drink).

Treatment:

Dietary Supplement: Intervention #2: Fresubin Energy Drink

Dietary Supplement: Intervention #3: Generic Glucose Solution

Dietary Supplement: Intervention #1: ProvideXtra Drink