Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
2016-06-30
2017-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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
Ultrasound
Baseline ultrasound is performed upon arrival. Ultrasound is performed when beverage is consumed and then every 30 minutes thereafter until stomach is empty.
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
Ultrasound
Baseline ultrasound is performed upon arrival. Ultrasound is performed when beverage is consumed and then every 30 minutes thereafter until stomach is empty.
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
Ultrasound
Baseline ultrasound is performed upon arrival. Ultrasound is performed when beverage is consumed and then every 30 minutes thereafter until stomach is empty.
ensure clear
16 participants will drink 10 ounces of ensure clear
Interventions
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Ultrasound
Baseline ultrasound is performed upon arrival. Ultrasound is performed when beverage is consumed and then every 30 minutes thereafter until stomach is empty.
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
Eligibility Criteria
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Inclusion Criteria
* Willing to not eat or drink for at least 8 hours overnight beforehand
* Have a BMI \< 35
Exclusion Criteria
* 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
8 Years
14 Years
ALL
Yes
Sponsors
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Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Principal Investigators
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Jayant Pratap, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Trung Du, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Locations
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Cincinnati Children's Medical Center
Cincinnati, Ohio, United States
Countries
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References
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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.
Other Identifiers
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2016-0566
Identifier Type: -
Identifier Source: org_study_id
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