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Gastric Emptying Ultrasound Research Study (GERS)

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ClinicalTrials.gov Identifier: NCT02938065
Recruitment Status : Completed
First Posted : October 19, 2016
Last Update Posted : August 23, 2017
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

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.

Condition or disease Intervention/treatment Phase
Gastric Emptying Procedure: Ultrasound Other: 2% milk Other: apple juice Other: ensure clear Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Gastric Emptying of Novel Protein and Carbohydrate Rich Clear Liquids
Study Start Date : June 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Arm Intervention/treatment
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

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

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




Primary Outcome Measures :
  1. Measurement of rate of gastric emptying through measure of the gastric antral cross-sectional area (CSA) [ Time Frame: Participants will be followed up to 6 hours after drinking 10 ounces of beverage ]
  2. Subjective evolution of hunger after ingestion of clear fluids using a validated visual analog scale called the Hunger Satiety Score [ Time Frame: Participants will be followed up to 6 hours after drinking 10 ounces of beverage ]


Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938065


Locations
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United States, Ohio
Cincinnati Children's Medical Center
Cincinnati, Ohio, United States, 45229-3039
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
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Principal Investigator: Jayant Pratap, MD Children's Hospital Medical Center, Cincinnati
Principal Investigator: Trung Du, MD Children's Hospital Medical Center, Cincinnati

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02938065     History of Changes
Other Study ID Numbers: 2016-0566
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017