Clinical trial NCT02938065: Gastric Emptying Ultrasound Research Study
Official title: Gastric Emptying of Novel Protein and Carbohydrate Rich Clear Liquids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Emptying
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2016-10-19
Enrollment: 48
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Measurement of rate of gastric emptying through measure of the gastric antral cross-sectional area (CSA)
timeFrame: Participants will be followed up to 6 hours after drinking 10 ounces of beverage
measure: Subjective evolution of hunger after ingestion of clear fluids using a validated visual analog scale called the Hunger Satiety Score
timeFrame: Participants will be followed up to 6 hours after drinking 10 ounces of beverage
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Jayant Pratap, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Medical Center, Cincinnati
name: Trung Du, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Du T, Hill L, Ding L, Towbin AJ, DeJonckheere M, Bennett P, Hagerman N, Varughese AM, Pratap JN. Gastric emptying for liquids of different compositions in children. Br J Anaesth. 2017 Nov 1;119(5):948-955. doi: 10.1093/bja/aex340.