Gastric VolumeNCT04093726
Lollipop on Gastric Volume
A study testing lollipop in people with Gastric Volume, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
To observe the effect of chewing lollipop on residual gastric volume in healthy volunteers with fasting. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Volume
- What is being tested?
- lollipop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 21 Oct 2019to 22 Dec 2019
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- volunteer aged 18 years-45 years old
- volunteer with a body mass index between 18 and 28 kg/m2
Who cannot join
- those with history of diabetes mellitus
- those with gastric diseases
- those with history of gastro-intestinal surgery
- those with history of smoking
- those with use of gastric mobility medicines
- those with pregnancy or breeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Chewing Lollipop on Gastric Residual Volume
To observe the effect of chewing lollipop on residual gastric volume in healthy volunteers with fasting.
- Conditions
- Gastric Volume
- Being tested
- lollipop
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lollipopOther
chewing lollipop for 20min
| Study group | Role | What they receive |
|---|---|---|
| lollipop | Experimental | Not described Receives: Other: lollipop |
| control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
residual gastric volume at 30 minutes after chewing lollipop
Measured: from starting chewing lollipop to 30 minutes after chewing, on an average of 30 minutes
Secondary outcomes (3)
residual gastric volume at 2 hours after chewing lollipop
Measured: from starting chewing lollipop to 2 hours after chewing, on an average of 2 hours
residual gastric volume at 1 hour after chewing lollipop
Measured: residual gastric volume at 1 hour after chewing lollipop
time to peak gastric volume
Measured: from starting chewing lollipop to gastric volume reaching peak , on an average of 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start21 Oct 2019
- Primary completion22 Dec 2019
- Study completion22 Dec 2019
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 VolumeStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhihong LU, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04093726
- Sponsor's protocol ID
- XJH-A-20190916-2
- Status last verified
- Apr 2020
- First submitted
- 16 Sep 2019
- Last updated
- 17 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data of primary and secondary outcomes could be shared
Publications
Schoenfelder RC, Ponnamma CM, Freyle D, Wang SM, Kain ZN. Residual gastric fluid volume and chewing gum before surgery. Anesth Analg. 2006 Feb;102(2):415-7. doi: 10.1213/01.ane.0000189218.07293.6e.
PubMed 16428535
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Chewing Lollipop on Gastric Residual Volume
- ClinicalTrials.gov ID
- NCT04093726
- Acronym / sponsor ID
- XJH-A-20190916-2
- Conditions
- Gastric Volume
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 22 Dec 2019 (actual)
- Study completion
- 22 Dec 2019 (actual)
- First posted
- 18 Sep 2019 (actual)
- 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.
To observe the effect of chewing lollipop on residual gastric volume in healthy volunteers with fasting.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lollipop | Experimental | Other: lollipop |
| control | No intervention | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- volunteer aged 18 years-45 years old
- volunteer with a body mass index between 18 and 28 kg/m2
Key exclusion criteria (6 listed)
- those with history of diabetes mellitus
- those with gastric diseases
- those with history of gastro-intestinal surgery
- those with history of smoking
- those with use of gastric mobility medicines
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 |
|---|---|---|
| lollipopchewing lollipop for 20min | Other | lollipop |
Primary outcome
residual gastric volume at 30 minutes after chewing lollipop
Time frame: from starting chewing lollipop to 30 minutes after chewing, on an average of 30 minutes
3 secondary outcomes
residual gastric volume at 2 hours after chewing lollipop
Time frame: from starting chewing lollipop to 2 hours after chewing, on an average of 2 hours
residual gastric volume at 1 hour after chewing lollipop
Time frame: residual gastric volume at 1 hour after chewing lollipop
time to peak gastric volume
Time frame: from starting chewing lollipop to gastric volume reaching peak , on an average of 1 hour
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 17 Apr 2020.
- Results publication: PubMed 16428535Schoenfelder RC, Ponnamma CM, Freyle D, Wang SM, Kain ZN. Residual gastric fluid volume and chewing gum before surgery. Anesth Analg. 2006 Feb;102(2):415-7. doi: 10.1213/01.ane.0000189218.07293.6e.
- Individual participant dataSharing planned: Undecided. Data of primary and secondary outcomes could be shared
Related trials for Gastric Volume
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Recruiting
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Enrolling by invitation
Premedication Gastric Ultrasound
Surgery
Recruiting
Continuous Versus Intermittent Enteral Feeding and Gastric Residual Volume in Critically Ill Patients
Enteral Feeding Intolerance, Critical Illness
Recruiting
Maltodextrin Versus Sugar Water Carbohydrate Loading and Gastric Volume in Geriatric Lower Limb Orthopedic Surgery
Respiratory Aspiration, Hyperglycemia
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lollipop in people with Gastric Volume, run by Air Force Military Medical University, China at 1 site in China.
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 2 inclusion and 6 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 17 Apr 2020. 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 China. 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?
residual gastric volume at 30 minutes after chewing lollipop (time frame: from starting chewing lollipop to 30 minutes after chewing, on an average of 30 minutes). 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 NCT04093726, 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 17 Apr 2020.