Gastric Emptying of High Calorie Liquid Meals

August 11, 2022 updated by: Razvan Bologheanu, Medical University of Vienna

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Sequence 123

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).
Dietary supplement: Intervention #1: ProvideXtra Drink
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
Dietary supplement: Intervention #2: Fresubin Energy Drink
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
Dietary supplement: Intervention #3: Generic Glucose Solution
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
EXPERIMENTAL: Sequence 132

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).
Dietary supplement: Intervention #1: ProvideXtra Drink
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
Dietary supplement: Intervention #2: Fresubin Energy Drink
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
Dietary supplement: Intervention #3: Generic Glucose Solution
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
EXPERIMENTAL: Sequence 213

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).
Dietary supplement: Intervention #1: ProvideXtra Drink
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
Dietary supplement: Intervention #2: Fresubin Energy Drink
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
Dietary supplement: Intervention #3: Generic Glucose Solution
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
EXPERIMENTAL: Sequence 231

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).
Dietary supplement: Intervention #1: ProvideXtra Drink
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
Dietary supplement: Intervention #2: Fresubin Energy Drink
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
Dietary supplement: Intervention #3: Generic Glucose Solution
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
EXPERIMENTAL: Sequence 312

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).
Dietary supplement: Intervention #1: ProvideXtra Drink
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
Dietary supplement: Intervention #2: Fresubin Energy Drink
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
Dietary supplement: Intervention #3: Generic Glucose Solution
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
EXPERIMENTAL: Sequence 321

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).
Dietary supplement: Intervention #1: ProvideXtra Drink
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
Dietary supplement: Intervention #2: Fresubin Energy Drink
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
Dietary supplement: Intervention #3: Generic Glucose Solution
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Andreas Duma, MSc, Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 28, 2022

Primary Completion (ACTUAL)

May 18, 2022

Study Completion (ACTUAL)

June 1, 2022

Study Registration Dates

First Submitted

March 28, 2022

First Submitted That Met QC Criteria

April 13, 2022

First Posted (ACTUAL)

April 18, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 12, 2022

Last Update Submitted That Met QC Criteria

August 11, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1700_2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will be accessed by the PI upon request.

IPD Sharing Time Frame

Data will be available from the PI 10 years after study completion.

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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