Gastric Emptying
Conditions
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.
Interventions
PROCEDUREUltrasound
Baseline ultrasound is performed upon arrival. Ultrasound is performed when beverage is consumed and then every 30 minutes thereafter until stomach is empty.
OTHER2% milk
16 participants will drink 10 ounces of 2% milk
OTHERapple juice
16 participants will drink 10 ounces of apple juice
OTHERensure clear
16 participants will drink 10 ounces of ensure clear
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 14 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Outcome results
None listed