Gastric ContentNCT02936882
Evaluation of Antral Ultrasonography for Full Stomach Diagnosis Before Pediatric Surgical Emergencies
A study testing Preoperative gastric ultrasonography in people with Gastric Content and Full Stomach Status, run by Hôpital Necker-Enfants Malades at 1 site in France.
Trial summary
This study evaluates antral ultrasonography for the diagnosis of full stomach before surgical emergencies in pediatric population. Preoperative ultrasonographic antral evaluation is compared to peroperative gastric aspirate with nasogastric tube. Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Gastric Content, Full Stomach Status
- What is being tested?
- Preoperative gastric ultrasonography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2016to Dec 2016
- 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 3 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Surgical emergency procedure
- ASA I-II
Who cannot join
- Ultrasound antrum assessment not possible
- No nasogastric tube during surgery
- Vital emergency
- Patient from Critical Care Ward
- Time between ultrasound assessment and gastric content collecting up to 20min
- Child and/or Parents doesn't/don't want to participate in the study
- Personal medical history of gastric or oesophagus desease
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Necker Enfants-Malades University Hospital - APHP
Paris, 75015
MAUPAIN Olivier, 0033171396697, olivier.maupain@aphp.fr
About this study
This study evaluates antral ultrasonography for the diagnosis of full stomach before surgical emergencies in pediatric population. Preoperative ultrasonographic antral evaluation is compared to peroperative gastric aspirate with nasogastric tube.
- Conditions
- Gastric Content, Full Stomach Status
- Being tested
- Preoperative gastric ultrasonography
- Keywords
- ultrasonography, aspiration, emergency, children, antrum
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative gastric ultrasonographyProcedure or surgery
Before surgical emergency procedure, a preoperative antral ultrasonography is performed to assess gastric content.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative gastric ultrasonography | Other | Not described Receives: Procedure: Preoperative gastric ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of gastric content aspirated throw nasogastric tube
Measured: 20 min
Secondary outcomes (7)
Grades as described by Perlas et al. for ultrasonographic qualitative evaluation of gastric content
Measured: 20 min
relationship between peroperative gastric content and ultrasonographic antrum assessment
Measured: 20 min
Time to perform antral ultrasonography
Measured: 20 min
Quality of image obtained during antral ultrasonography
Measured: 20 min
Child behaviour during antral ultrasonography
Measured: 20 min
Number of participants with exploitable antral ultrasonography
Measured: 20 min
Reasons for antral ultrasonography failure
Measured: 20 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric ContentStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital Necker-Enfants Malades
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivier MAUPAIN, Hôpital Necker-Enfants Malades
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936882
- Sponsor's protocol ID
- DAR_NCK_OMN0001
- Status last verified
- Oct 2016
- First submitted
- 6 Oct 2016
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Antral Ultrasonography for Full Stomach Diagnosis Before Pediatric Surgical Emergencies
- ClinicalTrials.gov ID
- NCT02936882
- Acronym / sponsor ID
- DAR_NCK_OMN0001
- Conditions
- Gastric Content, Full Stomach Status
- Keywords
- ultrasonography, aspiration, emergency, children, antrum
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hôpital Necker-Enfants MaladesUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Dec 2016 (estimated)
- First posted
- 18 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.
This study evaluates antral ultrasonography for the diagnosis of full stomach before surgical emergencies in pediatric population. Preoperative ultrasonographic antral evaluation is compared to peroperative gastric aspirate with nasogastric tube.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preoperative gastric ultrasonography | Other | Procedure: Preoperative gastric ultrasonography |
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Surgical emergency procedure
- ASA I-II
Key exclusion criteria (7 listed)
- Ultrasound antrum assessment not possible
- No nasogastric tube during surgery
- Vital emergency
- Patient from Critical Care Ward
- Time between ultrasound assessment and gastric content collecting up to 20min
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 |
|---|---|---|
| Preoperative gastric ultrasonographyBefore surgical emergency procedure, a preoperative antral ultrasonography is performed to assess gastric content. | Procedure or surgery | Preoperative gastric ultrasonography |
Primary outcome
Volume of gastric content aspirated throw nasogastric tube
Time frame: 20 min
7 secondary outcomes
Grades as described by Perlas et al. for ultrasonographic qualitative evaluation of gastric content
Time frame: 20 min
relationship between peroperative gastric content and ultrasonographic antrum assessment
Time frame: 20 min
Time to perform antral ultrasonography
Time frame: 20 min
Quality of image obtained during antral ultrasonography
Time frame: 20 min
Child behaviour during antral ultrasonography
Time frame: 20 min
Number of participants with exploitable antral ultrasonography
Time frame: 20 min
Reasons for antral ultrasonography failure
Time frame: 20 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative gastric ultrasonography in people with Gastric Content and Full Stomach Status, run by Hôpital Necker-Enfants Malades at 1 site in France.
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 7 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: status not confirmed, as of the sponsor's last update on 18 Oct 2016. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of gastric content aspirated throw nasogastric tube (time frame: 20 min). 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 Oct 2016.