Gastric EmptyingGERSNCT02938065
Gastric Emptying Ultrasound Research Study
A study testing Ultrasound, 2% milk and apple juice in people with Gastric Emptying, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Emptying
- What is being tested?
- Ultrasound, 2% milk and apple juice
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 8-14 years old
- Willing to not eat or drink for at least 8 hours overnight beforehand
- Have a BMI < 35
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Medical Center
Cincinnati, Ohio, 45229-3039
About this study
Official title: 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.
Read the 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.
- Conditions
- Gastric Emptying
- Being tested
- Ultrasound, 2% milk, apple juice, ensure clear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundProcedure or surgery
Baseline ultrasound is performed upon arrival. Ultrasound is performed when beverage is consumed and then every 30 minutes thereafter until stomach is empty.
2% milkOther
16 participants will drink 10 ounces of 2% milk
apple juiceOther
16 participants will drink 10 ounces of apple juice
ensure clearOther
16 participants will drink 10 ounces of ensure clear
| Study group | Role | What they receive |
|---|---|---|
| 2% Milk | Other | 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 Receives: Procedure: Ultrasound; Other: 2% milk |
| Apple Juice | Other | 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 Receives: Procedure: Ultrasound; Other: apple juice |
| Ensure Clear | Other | 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 Receives: Procedure: Ultrasound; Other: ensure clear |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of rate of gastric emptying through measure of the gastric antral cross-sectional area (CSA)
Measured: 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
Measured: Participants will be followed up to 6 hours after drinking 10 ounces of beverage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric EmptyingStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jayant Pratap, MD, Principal investigator, Children's Hospital Medical Center, CincinnatiTrung Du, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02938065
- Sponsor's protocol ID
- 2016-0566
- Acronym
- GERS
- Status last verified
- Aug 2017
- First submitted
- 25 Jul 2016
- Last updated
- 23 Aug 2017
- Results posted
- No
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.
PubMed 29077812
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Emptying of Novel Protein and Carbohydrate Rich Clear Liquids
- ClinicalTrials.gov ID
- NCT02938065
- Acronym / sponsor ID
- GERS / 2016-0566
- Conditions
- Gastric Emptying
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 19 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2% Milk | Other | Procedure: Ultrasound, Other: 2% milk16 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 |
| Apple Juice | Other | Procedure: Ultrasound, Other: apple juice16 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 |
| Ensure Clear | Other | Procedure: Ultrasound, Other: ensure clear16 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 |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 8-14 years old
- Willing to not eat or drink for at least 8 hours overnight beforehand
- Have a BMI < 35
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundBaseline ultrasound is performed upon arrival. Ultrasound is performed when beverage is consumed and then every 30 minutes thereafter until stomach is empty. | Procedure or surgery | 2% Milk, Apple Juice, Ensure Clear |
| 2% milk16 participants will drink 10 ounces of 2% milk | Other | 2% Milk |
| apple juice16 participants will drink 10 ounces of apple juice | Other | Apple Juice |
| ensure clear16 participants will drink 10 ounces of ensure clear | Other | Ensure Clear |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2017.
- Derived from this study: PubMed 29077812Du 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jayant Pratap, MD principal investigator
Children's Hospital Medical Center, Cincinnati
Trung Du, MD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound, 2% milk and apple juice in people with Gastric Emptying, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02938065, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2017.