Gastric EmptyingNCT01133691
Examination of Gastric Emptying in Children
An observational study of Gastric Emptying, run by University Children's Hospital, Zurich at 1 site in Switzerland.
Trial summary
Background: Fasting is mandatory for safety of anesthesia in elective surgery and imaging but gives rise to discomfort, hunger and thirst especially in children. Internationally accepted fasting times are often prolonged because of organisational delay in operating theatre. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Emptying
- What is being tested?
- clear fluid, light breakfast
- How many people
- 31 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2010to Feb 2011
- Phase
- Observational
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: healthy children aged 6 - 12 years old
Who may be able to join
- age 6 - 12 years
- ASA I or II
Who cannot join
- gastrointestinal pathology
- claustrophobia
- implants like pacemaker, ventriculoperitoneal shunt etc
- symptomatic or relevant cardiac, renal or metabolic disease
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Children's Hospital, Anesthesiology
Zurich, Canton of Zurich, 8032
About this study
Official title: Examination of Gastric Emptying With Magnetic Resonance Imaging and Ultrasonography
- Background: Fasting is mandatory for safety of anesthesia in elective surgery and imaging but gives rise to discomfort, hunger and thirst especially in children. Internationally accepted fasting times are often prolonged because of organisational delay in operating theatre.
- Hypothesis: Clear fluids can be ingested until an imaginary anesthesia induction time without enlarging the residual gastric contents compared to overnight fast. There is no difference between residual gastric contents after 4 hours of fasting after a light meal compare to 6 hours in healthy children.
- Examination of gastric volume using magnetic resonance imaging after overnight fasting and subsequent scans after either clear fluid intake or intake of a standard breakfast are performed in children aged 6 - 12 years. Time course after fluid intake is followed with scans every half hour for 2 hours. In the breakfast group 4 versus 6 hours fasting time will be simulated, e. g. intake of clear fluid is allowed for 2 versus 4 hours after the meal. Volume of gastric contents will be compared with a standardized ultrasonographic view of the stomach.
- Conditions
- Gastric Emptying
- Being tested
- clear fluid, light breakfast
- Keywords
- gastric emptying, children, gastric fluid volume, preoperative fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clear fluid, light breakfastDietary supplement
clear fluid 7 ml/kg, breakfast consisting of yoghurt, muesli, mild
| Study group | Role | What they receive |
|---|---|---|
| healthy children aged 6 - 12 years | Not described Receives: Dietary Supplement: clear fluid, light breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric emptying time
Time after food/fluid ingestion when gastric volume after overnight fast is achieved, as measured by volumetry of magnetic resonance scans
Measured: 6 hours
Secondary outcomes (3)
gastric volume after fasting
Measured: 6 hours
gastric antral area
Measured: 6 hours
visual analog scale of thirst/hunger
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2010 (estimated)
- Study startMay 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric EmptyingStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Achim J Schmitz, MD, Principal investigator, Children's University Hospital Zurich, Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133691
- Sponsor's protocol ID
- KEK-ZH-Nr. 2009-0147
- Status last verified
- Jan 2012
- First submitted
- 11 May 2010
- Last updated
- 18 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Gastric Emptying With Magnetic Resonance Imaging and Ultrasonography
- ClinicalTrials.gov ID
- NCT01133691
- Acronym / sponsor ID
- KEK-ZH-Nr. 2009-0147
- Conditions
- Gastric Emptying
- Keywords
- gastric emptying, children, gastric fluid volume, preoperative fasting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 31 May 2010 (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.
- Background: Fasting is mandatory for safety of anesthesia in elective surgery and imaging but gives rise to discomfort, hunger and thirst especially in children. Internationally accepted fasting times are often prolonged because of organisational delay in operating theatre.
- Hypothesis: Clear fluids can be ingested until an imaginary anesthesia induction time without enlarging the residual gastric contents compared to overnight fast. There is no difference between residual gastric contents after 4 hours of fasting after a light meal compare to 6 hours in healthy children.
- Examination of gastric volume using magnetic resonance imaging after overnight fasting and subsequent scans after either clear fluid intake or intake of a standard breakfast are performed in children aged 6 - 12 years. Time course after fluid intake is followed with scans every half hour for 2 hours. In the breakfast group 4 versus 6 hours fasting time will be simulated, e. g. intake of clear fluid is allowed for 2 versus 4 hours after the meal. Volume of gastric contents will be compared with a standardized ultrasonographic view of the stomach.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy children aged 6 - 12 years | – | Dietary Supplement: clear fluid, light breakfast |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- healthy children aged 6 - 12 years old
Key inclusion criteria (2 listed)
- age 6 - 12 years
- ASA I or II
Key exclusion criteria (4 listed)
- gastrointestinal pathology
- claustrophobia
- implants like pacemaker, ventriculoperitoneal shunt etc
- symptomatic or relevant cardiac, renal or metabolic disease
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 |
|---|---|---|
| clear fluid, light breakfastclear fluid 7 ml/kg, breakfast consisting of yoghurt, muesli, mild | Dietary supplement | healthy children aged 6 - 12 years |
Primary outcome
Gastric emptying time
Time frame: 6 hours
Time after food/fluid ingestion when gastric volume after overnight fast is achieved, as measured by volumetry of magnetic resonance scans
3 secondary outcomes
gastric volume after fasting
Time frame: 6 hours
gastric antral area
Time frame: 6 hours
visual analog scale of thirst/hunger
Time frame: 6 hours
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 18 Jan 2012.
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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.
Achim J Schmitz, MD principal investigator
Children's University Hospital Zurich, Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Emptying, run by University Children's Hospital, Zurich at 1 site in Switzerland.
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 4 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 18 Jan 2012. 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 Switzerland. 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?
Gastric emptying time (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2012.