Gastric Emptying Ultrasound Research Study
- Conditions
- Gastric Emptying
- Interventions
- Procedure: UltrasoundOther: 2% milkOther: apple juiceOther: ensure clear
- Registration Number
- NCT02938065
- Lead Sponsor
- Children's Hospital Medical Center, Cincinnati
- Brief Summary
The proposed study will use this technology to observe emptying of the stomach of a protein and carbohydrate rich clear liquid sports/nutrition drink.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- 8-14 years old
- Willing to not eat or drink for at least 8 hours overnight beforehand
- Have a BMI < 35
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2% Milk Ultrasound 16 participants will drink 10 ounces of 2% milk Ultrasound scan will be performed at the time of beverage administration and then every 30 minutes thereafter until beverage has been cleared from the stomach Apple Juice Ultrasound 16 participants will drink 10 ounces of apple juice Ultrasound scan will be performed at the time of beverage administration and then every 30 minutes thereafter until beverage has been cleared from the stomach Ensure Clear Ultrasound 16 participants will drink 10 ounces of ensure clear Ultrasound scan will be performed at the time of beverage administration and then every 30 minutes thereafter until beverage has been cleared from the stomach 2% Milk 2% milk 16 participants will drink 10 ounces of 2% milk Ultrasound scan will be performed at the time of beverage administration and then every 30 minutes thereafter until beverage has been cleared from the stomach Apple Juice apple juice 16 participants will drink 10 ounces of apple juice Ultrasound scan will be performed at the time of beverage administration and then every 30 minutes thereafter until beverage has been cleared from the stomach Ensure Clear ensure clear 16 participants will drink 10 ounces of ensure clear Ultrasound scan will be performed at the time of beverage administration and then every 30 minutes thereafter until beverage has been cleared from the stomach
- Primary Outcome Measures
Name Time Method Measurement of rate of gastric emptying through measure of the gastric antral cross-sectional area (CSA) Participants will be followed up to 6 hours after drinking 10 ounces of beverage Subjective evolution of hunger after ingestion of clear fluids using a validated visual analog scale called the Hunger Satiety Score Participants will be followed up to 6 hours after drinking 10 ounces of beverage
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cincinnati Children's Medical Center
🇺🇸Cincinnati, Ohio, United States