Gastric Emptying Ultrasound Research Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Gastric Emptying of Novel Protein and Carbohydrate Rich Clear Liquids

Conditions
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Gastric Emptying

Intervention / Treatment
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* Procedure: Ultrasound
* Other: 2% milk
* Other: apple juice
* Other: ensure clear


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 2% Milk<br>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 | Procedure: Ultrasound<br>* Baseline ultrasound is performed upon arrival. Ultrasound is performed when beverage is consumed and then every 30 minutes thereafter until stomach is empty.<br>Other: 2% milk<br>* 16 participants will drink 10 ounces of 2% milk<br>|
| Other: Apple Juice<br>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 | Procedure: Ultrasound<br>* Baseline ultrasound is performed upon arrival. Ultrasound is performed when beverage is consumed and then every 30 minutes thereafter until stomach is empty.<br>Other: apple juice<br>* 16 participants will drink 10 ounces of apple juice<br>|
| Other: Ensure Clear<br>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 | Procedure: Ultrasound<br>* Baseline ultrasound is performed upon arrival. Ultrasound is performed when beverage is consumed and then every 30 minutes thereafter until stomach is empty.<br>Other: ensure clear<br>* 16 participants will drink 10 ounces of ensure clear<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |