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OpenTrials
Completed

NCT Number: NCT02938065

Gastric Emptying Ultrasound Research Study

The proposed study will use this technology to observe emptying of the stomach of a protein and carbohydrate rich clear liquid sports/nutrition drink.

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Key information

Conditions

Age range

8 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Medical Center

Cincinnati, Ohio, 45229-3039, United States

About this study

In order to ensure safety for elective anesthesia, standard practice requires pre-operative fasting to ensure that the stomach is empty prior to induction. The question of timing of pre-operative consumption of oral fluids remains vexed, and challenges anesthesiologists on a frequent basis. In the past few years, a new controversy in pre-operative fasting has arisen: clear drinks with increased content of protein and carbohydrate have been introduced to the market. Families and professionals alike are confused whether to regard these products as clear liquids (2 hours fasting) or as solids (at least 6 hours).

Ultrasound is now considered an accepted tool in the anesthesia literature as a surrogate for aspiration risk with different materials and in different disease states.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 8-14 years old
  • Willing to not eat or drink for at least 8 hours overnight beforehand
  • Have a BMI < 35

Exclusion criteria

  • Use tobacco of any kind
  • Taking any medications (Females: oral contraceptives okay)
  • Suffers from diabetes, Crohn's Disease, Celiac Disease, Malabsorption, Galactosemia
  • Has ever has surgery on esophagus, stomach, or small bowel
  • Has allergies or intolerances to milk, apple juice, or ensure clear
  • Has any surgical condition, disease, or on any medication that could alter stomach emptying rate
  • Has any disease that limits day-to-day activities
  • Is pregnant or possibly could be pregnant

Treatment and study plan

Ultrasound

Procedure

Baseline ultrasound is performed upon arrival. Ultrasound is performed when beverage is consumed and then every 30 minutes thereafter until stomach is empty.

2% milk

Other

16 participants will drink 10 ounces of 2% milk

Apple juice

Other

16 participants will drink 10 ounces of apple juice

ensure clear

Other

16 participants will drink 10 ounces of ensure clear

Primary outcomes

  1. Measurement of rate of gastric emptying through measure of the gastric antral cross-sectional area (CSA)

    Time frame: Participants will be followed up to 6 hours after drinking 10 ounces of beverage

  2. Subjective evolution of hunger after ingestion of clear fluids using a validated visual analog scale called the Hunger Satiety Score

    Time frame: Participants will be followed up to 6 hours after drinking 10 ounces of beverage

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

Gastric Emptying of Novel Protein and Carbohydrate Rich Clear Liquids

Acronym: GERS

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 19, 2016
Registry last updated
Aug 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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