Gastric Emptying Ultrasound Research Study

NCT ID: NCT02938065

Last Updated: 2017-08-23

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Gastric Emptying

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

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

Group Type OTHER

Ultrasound

Intervention Type PROCEDURE

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

Intervention Type OTHER

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

Group Type OTHER

Ultrasound

Intervention Type PROCEDURE

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

Intervention Type OTHER

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

Group Type OTHER

Ultrasound

Intervention Type PROCEDURE

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

Intervention Type OTHER

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.

Intervention Type PROCEDURE

2% milk

16 participants will drink 10 ounces of 2% milk

Intervention Type OTHER

apple juice

16 participants will drink 10 ounces of apple juice

Intervention Type OTHER

ensure clear

16 participants will drink 10 ounces of ensure clear

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 29077812 (View on PubMed)

Other Identifiers

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2016-0566

Identifier Type: -

Identifier Source: org_study_id

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