Gastric Emptying Ultrasound Research Study

Not Applicable

Completed

• Conditions: Gastric Emptying

• 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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-07-25
• Study First Submitted QC: 2016-10-17
• Study First Posted: 2016-10-19
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-21
• Last Update Posted: 2017-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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

Trial Locations

Locations (1)

Cincinnati Children's Medical Center; 🇺🇸 Cincinnati, Ohio, United States