Gastric Emptying Ultrasound Research Study (GERS)

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Gastric Emptying

Treatments: Other: ensure clear; Other: apple juice; Procedure: Ultrasound; Other: 2% milk

Study type: Interventional

Funder types: Other

Identifiers

NCT02938065

2016-0566

Details and patient eligibility

About

The proposed study will use this technology to observe emptying of the stomach of a protein and carbohydrate rich clear liquid sports/nutrition drink.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 8 to 14 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 3 patient groups

2% Milk

Other group

Description:

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

Treatment:

Procedure: Ultrasound

Other: 2% milk

Apple Juice

Other group

Description:

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

Treatment:

Procedure: Ultrasound

Other: apple juice

Ensure Clear

Other group

Description:

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

Treatment:

Other: ensure clear

Procedure: Ultrasound