Gastric Emptying Ultrasound Research Study

Gastric Emptying Clinical Trial

— GERS  

Official title:

Gastric Emptying of Novel Protein and Carbohydrate Rich Clear Liquids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02938065
• Other study ID #: 2016-0566
• Status: Completed
• Phase: N/A
• First received: July 25, 2016
• Last updated: August 21, 2017
• Start date: June 2016
• Est. completion date: June 2017

Study information

• Verified date: August 2017
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Emptying

Intervention

Procedure:
• Ultrasound
Baseline ultrasound is performed upon arrival. Ultrasound is performed when beverage is consumed and then every 30 minutes thereafter until stomach is empty.

Other:
• 2% milk
16 participants will drink 10 ounces of 2% milk
• apple juice
16 participants will drink 10 ounces of apple juice
• ensure clear
16 participants will drink 10 ounces of ensure clear

Locations

Country	Name	City	State
United States	Cincinnati Children's Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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