Gastric Emptying Ultrasound Research Study (GERS)

Gastric Emptying of Novel Protein and Carbohydrate Rich Clear Liquids

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

Study Overview

• Status: Completed
• Conditions: Gastric Emptying
• Intervention / Treatment: Procedure: Ultrasound; Other: 2% milk; Other: apple juice; Other: ensure clear

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229-3039
      • Cincinnati Children's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 2% Milk; 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	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
Other: Apple Juice; 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	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: apple juice; 16 participants will drink 10 ounces of apple juice
Other: Ensure Clear; 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	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: ensure clear; 16 participants will drink 10 ounces of ensure clear

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Investigators: Principal Investigator: Jayant Pratap, MD, Children's Hospital Medical Center, Cincinnati; Principal Investigator: Trung Du, MD, Children's Hospital Medical Center, Cincinnati

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: July 25, 2016
• First Submitted That Met QC Criteria: October 17, 2016
• First Posted (Estimate): October 19, 2016

Study Record Updates

• Last Update Posted (Actual): August 23, 2017
• Last Update Submitted That Met QC Criteria: August 21, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 2016-0566