Healthy VolunteerQUALIGASTRNCT06079268
Diagnostic Performance of Gastric Ultrasound in Children
A study testing the initial gastric ultrasound and the gastric ultrasound last 3 minutes in people with Healthy Volunteer, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Pulmonary aspiration of gastric contents is a complication responsible for the third highest cause of anaesthesia-related mortality in France, and for 50% of airway management-related mortality in the UK. Read more about this study
- Who is it for?
- Ages 1 year to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- the initial gastric ultrasound and the gastric ultrasound last 3 minutes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteFrance
- Study dates
- 20 Dec 2023to 15 Apr 2024
- 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 1 year to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged between 1 and 10 years
- Healthy volunteer, with no significant medical history (American Society of Anesthesiologists class ASA 1)
- Fasting according to the 2022 recommendations of the European Society of Anaesthesia: minimum fasting time of 1 h for clear liquids, 3 h for breast milk, 4 h for infant formula, 6 h for solid non-fatty foods and milk, 8 h for richer meals
- Informed consent signed by the child's legal representatives,
- affiliated to a social security scheme
Who cannot join
- Agitation of the child preventing gastric ultrasound scans from being performed
- Non-compliance with fasting instructions
- Previous oeso-gastro-duodenal surgery
- Treatments affecting gastric motility (erythromycin, metoclopramide, etc.)
- Obesity defined by a body mass index ≥ 30 kg/m².
- Pathologies that may affect gastric volume: insulin-dependent or requiring diabetes, gastro-oesophageal reflux, scleroderma, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Diagnostic Performance of Qualitative Ultrasound Assessment of Gastric Contents for the Detection of Gastric Fluid Volume ≥ 1.25 ml/kg in Children
Pulmonary aspiration of gastric contents is a complication responsible for the third highest cause of anaesthesia-related mortality in France, and for 50% of airway management-related mortality in the UK. The occurrence of pulmonary aspiration of gastric contents is often the result of a poor assessment of the risk of a "full" stomach, and could therefore often be avoided if the preoperative gastric contents were known to the anaesthetist. It is therefore useful to be able to discriminate easily between patients at risk of aspiration and those at low risk before general anaesthesia, and this can be done by ultrasound examination of the gastric contents in the gastric antrum, non-invasively (abdominal ultrasound) using a 2-5 MHz abdominal ultrasound probe or a high-frequency linear probe in small children (under 10 kg). European recommendations on preoperative fasting in paediatrics recommend that the examination should be interpreted in a qualitative manner only, without measuring the antral surface. However, the diagnostic performance of this qualitative approach alone has never been evaluated. The aim of this study was to determine the diagnostic performance of the qualitative assessment of gastric contents by ultrasound in children, and to compare it with that of the clinical algorithm, for the detection of a volume of fluid greater than 1.25 ml/kg.
Children will present themselves in the morning after fasting. Upon arrival, if their weight is not known, the children will be weighed. Subsequently, they will be positioned on an examination table in a supine inclined position at 45° (head of the bed elevated). An initial gastric ultrasound will be performed by a physician (investigator 1) who will not conduct the study ultrasounds. This initial ultrasound aims to confirm the absence of gastric content in the supine and right lateral decubitus positions, thereby establishing gastric emptiness.
Read more
Investigator 1 will then proceed with the random selection of the clear liquid volume to be ingested for the study.
The child will then be asked to drink this determined volume of clear liquid (water or apple juice according to their preference), as per the randomization results, under the supervision of the first investigator who performed the initial ultrasound.
Subsequently, investigator 2 will perform a gastric ultrasound blindly with respect to the ingested liquid volume, three minutes after the consumption of the clear liquid. The examination will last a maximum of 3 minutes.
Non-invasive gastric antrum ultrasound examinations will utilize a probe with a frequency of 2-5.5 MHz and a linear probe with a frequency of 10 MHz, enabling the evaluation of the gastric antrum's appearance. The diameters (longitudinal D1 and anteroposterior D2) of the antrum will also be measured in the supine (semi-seated and lying) and right lateral positions in the sagittal plane passing through the abdominal aorta and the left lobe of the liver, for the calculation of the antral section area, given by the formula: Antral area = π x D1 x D2 / 4.
- Conditions
- Healthy Volunteer
- Being tested
- the initial gastric ultrasound, the gastric ultrasound last 3 minutes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the initial gastric ultrasoundOther
Non-invasive gastric antrum ultrasound examinations will utilize a probe with a frequency of 2-5.5 MHz and a linear probe with a frequency of 10 MHz, enabling the evaluation of the gastric antrum's appearance
the gastric ultrasound last 3 minutesOther
Non-invasive gastric antrum ultrasound examinations will utilize a probe with a frequency of 2-5.5 MHz and a linear probe with a frequency of 10 MHz, enabling the evaluation of the gastric antrum's appearance
| Study group | Role | What they receive |
|---|---|---|
| 0 ml/kg of water | Experimental | The child does not drink water, and then the gastric ultrasound is performed 3 minutes later blindly to the ingested volume. Receives: Other: the initial gastric ultrasound; Other: the gastric ultrasound last 3 minutes |
| 0.6 ml/kg of water | Experimental | The child drinks 0.6 ml/kg water, and then the gastric ultrasound is performed 3 minutes later blindly to the ingested volume. Receives: Other: the initial gastric ultrasound; Other: the gastric ultrasound last 3 minutes |
| 1 ml/kg of water | Experimental | The child drinks 1 ml/kg water, and then the gastric ultrasound is performed 3 minutes later blindly to the ingested volume. Receives: Other: the initial gastric ultrasound; Other: the gastric ultrasound last 3 minutes |
| 1.25 ml/kg of water | Experimental | The child drinks 1.25 ml/kg water, and then the gastric ultrasound is performed 3 minutes later blindly to the ingested volume Receives: Other: the initial gastric ultrasound; Other: the gastric ultrasound last 3 minutes |
| 1.5 ml/kg of water | Experimental | The child drinks 1.5 ml/kg water, and then the gastric ultrasound is performed 3 minutes later blindly to the ingested volume. Receives: Other: the initial gastric ultrasound; Other: the gastric ultrasound last 3 minutes |
| 2 ml/kg of water | Experimental | The child drinks 2 ml/kg water, and then the gastric ultrasound is performed 3 minutes later blindly to the ingested volume. Receives: Other: the initial gastric ultrasound; Other: the gastric ultrasound last 3 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of the qualitative examination of the gastric antrum for the detection of gastric fluid volume ≥ 1.25 ml/kg in the 45° semirecumbent position
Calculation of the sensitivity and specificity
Measured: 3 minutes after the ingestion of water
Secondary outcomes (2)
Positive predictive value, negative predictive value, positive and negative likelihood ratio of the qualitative examination of the gastric antrum for the detection of gastric fluid volume ≥ 1.25 ml/kg in the 45° semirecumbent position
Calculation of the positive predictive value, negative predictive value, positive and negative likelihood ratio
Measured: 3 minutes after the ingestion of water
Diagnostic performance of a clinical algorithm used for the interpretation of gastric ultrasound for the detection of gastric fluid volume ≥ 1.25 ml/kg in the 45° semirecumbent position
Calculation of the sensitivity, specificity, positive predictive value, negative predictive value, positive and negative likelihood ratiovalue, positive and negative likelihood ratio
Measured: 3 minutes after the ingestion of water
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start20 Dec 2023
- Primary completion15 Apr 2024
- Study completion15 Apr 2024
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 Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lionel BOUVET, Dr, Principal investigator, Hôpital Femme Mère Enfant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06079268
- Sponsor's protocol ID
- 69HCL23_0690
- Acronym
- QUALIGASTR
- Status last verified
- Sep 2025
- First submitted
- 6 Oct 2023
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cercueil E, Henriet A, Barbe C, Santos Machado G, Bouvet L. Diagnostic accuracy of qualitative gastric ultrasound assessment for detecting high gastric fluid volume in children: a prospective randomised study. Anaesthesia. 2025 Jun;80(6):636-644. doi: 10.1111/anae.16539. Epub 2025 Jan 7.
PubMed 39764617
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Diagnostic Performance of Qualitative Ultrasound Assessment of Gastric Contents for the Detection of Gastric Fluid Volume ≥ 1.25 ml/kg in Children
- ClinicalTrials.gov ID
- NCT06079268
- Acronym / sponsor ID
- QUALIGASTR / 69HCL23_0690
- Conditions
- Healthy Volunteer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 12 Oct 2023 (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.
Pulmonary aspiration of gastric contents is a complication responsible for the third highest cause of anaesthesia-related mortality in France, and for 50% of airway management-related mortality in the UK. The occurrence of pulmonary aspiration of gastric contents is often the result of a poor assessment of the risk of a "full" stomach, and could therefore often be avoided if the preoperative gastric contents were known to the anaesthetist. It is therefore useful to be able to discriminate easily between patients at risk of aspiration and those at low risk before general anaesthesia, and this can be done by ultrasound examination of the gastric contents in the gastric antrum, non-invasively (abdominal ultrasound) using a 2-5 MHz abdominal ultrasound probe or a high-frequency linear probe in small children (under 10 kg). European recommendations on preoperative fasting in paediatrics recommend that the examination should be interpreted in a qualitative manner only, without measuring the antral surface. However, the diagnostic performance of this qualitative approach alone has never been evaluated. The aim of this study was to determine the diagnostic performance of the qualitative assessment of gastric contents by ultrasound in children, and to compare it with that of the clinical algorithm, for the detection of a volume of fluid greater than 1.25 ml/kg.
Children will present themselves in the morning after fasting. Upon arrival, if their weight is not known, the children will be weighed. Subsequently, they will be positioned on an examination table in a supine inclined position at 45° (head of the bed elevated). An initial gastric ultrasound will be performed by a physician (investigator 1) who will not conduct the study ultrasounds. This initial ultrasound aims to confirm the absence of gastric content in the supine and right lateral decubitus positions, thereby establishing gastric emptiness.
Investigator 1 will then proceed with the random selection of the clear liquid volume to be ingested for the study.
The child will then be asked to drink this determined volume of clear liquid (water or apple juice according to their preference), as per the randomization results, under the supervision of the first investigator who performed the initial ultrasound.
Subsequently, investigator 2 will perform a gastric ultrasound blindly with respect to the ingested liquid volume, three minutes after the consumption of the clear liquid. The examination will last a maximum of 3 minutes.
Non-invasive gastric antrum ultrasound examinations will utilize a probe with a frequency of 2-5.5 MHz and a linear probe with a frequency of 10 MHz, enabling the evaluation of the gastric antrum's appearance. The diameters (longitudinal D1 and anteroposterior D2) of the antrum will also be measured in the supine (semi-seated and lying) and right lateral positions in the sagittal plane passing through the abdominal aorta and the left lobe of the liver, for the calculation of the antral section area, given by the formula: Antral area = π x D1 x D2 / 4.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 0 ml/kg of water | Experimental | Other: the initial gastric ultrasound, Other: the gastric ultrasound last 3 minutesThe child does not drink water, and then the gastric ultrasound is performed 3 minutes later blindly to the ingested volume. |
| 0.6 ml/kg of water | Experimental | Other: the initial gastric ultrasound, Other: the gastric ultrasound last 3 minutesThe child drinks 0.6 ml/kg water, and then the gastric ultrasound is performed 3 minutes later blindly to the ingested volume. |
| 1 ml/kg of water | Experimental | Other: the initial gastric ultrasound, Other: the gastric ultrasound last 3 minutesThe child drinks 1 ml/kg water, and then the gastric ultrasound is performed 3 minutes later blindly to the ingested volume. |
| 1.25 ml/kg of water | Experimental | Other: the initial gastric ultrasound, Other: the gastric ultrasound last 3 minutesThe child drinks 1.25 ml/kg water, and then the gastric ultrasound is performed 3 minutes later blindly to the ingested volume |
| 1.5 ml/kg of water | Experimental | Other: the initial gastric ultrasound, Other: the gastric ultrasound last 3 minutesThe child drinks 1.5 ml/kg water, and then the gastric ultrasound is performed 3 minutes later blindly to the ingested volume. |
| 2 ml/kg of water | Experimental | Other: the initial gastric ultrasound, Other: the gastric ultrasound last 3 minutesThe child drinks 2 ml/kg water, and then the gastric ultrasound is performed 3 minutes later blindly to the ingested volume. |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged between 1 and 10 years
- Healthy volunteer, with no significant medical history (American Society of Anesthesiologists class ASA 1)
- Fasting according to the 2022 recommendations of the European Society of Anaesthesia: minimum fasting time of 1 h for clear liquids, 3 h for breast milk, 4 h for infant formula, 6 h for solid non-fatty foods and milk, 8 h for richer meals
- Informed consent signed by the child's legal representatives,
- affiliated to a social security scheme
Key exclusion criteria (6 listed)
- Agitation of the child preventing gastric ultrasound scans from being performed
- Non-compliance with fasting instructions
- Previous oeso-gastro-duodenal surgery
- Treatments affecting gastric motility (erythromycin, metoclopramide, etc.)
- Obesity defined by a body mass index ≥ 30 kg/m².
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 |
|---|---|---|
| the initial gastric ultrasoundNon-invasive gastric antrum ultrasound examinations will utilize a probe with a frequency of 2-5.5 MHz and a linear probe with a frequency of 10 MHz, enabling the evaluation of the gastric antrum's appearance | Other | 0 ml/kg of water, 0.6 ml/kg of water, 1 ml/kg of water, 1.25 ml/kg of water, 1.5 ml/kg of water, 2 ml/kg of water |
| the gastric ultrasound last 3 minutesNon-invasive gastric antrum ultrasound examinations will utilize a probe with a frequency of 2-5.5 MHz and a linear probe with a frequency of 10 MHz, enabling the evaluation of the gastric antrum's appearance | Other | 0 ml/kg of water, 0.6 ml/kg of water, 1 ml/kg of water, 1.25 ml/kg of water, 1.5 ml/kg of water, 2 ml/kg of water |
Primary outcome
Sensitivity and specificity of the qualitative examination of the gastric antrum for the detection of gastric fluid volume ≥ 1.25 ml/kg in the 45° semirecumbent position
Time frame: 3 minutes after the ingestion of water
Calculation of the sensitivity and specificity
2 secondary outcomes
Positive predictive value, negative predictive value, positive and negative likelihood ratio of the qualitative examination of the gastric antrum for the detection of gastric fluid volume ≥ 1.25 ml/kg in the 45° semirecumbent position
Time frame: 3 minutes after the ingestion of water
Diagnostic performance of a clinical algorithm used for the interpretation of gastric ultrasound for the detection of gastric fluid volume ≥ 1.25 ml/kg in the 45° semirecumbent position
Time frame: 3 minutes after the ingestion of water
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 9 Sep 2025.
- Results publication: PubMed 39764617Cercueil E, Henriet A, Barbe C, Santos Machado G, Bouvet L. Diagnostic accuracy of qualitative gastric ultrasound assessment for detecting high gastric fluid volume in children: a prospective randomised study. Anaesthesia. 2025 Jun;80(6):636-644. doi: 10.1111/anae.16539. Epub 2025 Jan 7.
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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.
Lionel BOUVET, Dr principal investigator
Hôpital Femme Mère Enfant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the initial gastric ultrasound and the gastric ultrasound last 3 minutes in people with Healthy Volunteer, run by Hospices Civils de Lyon 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 5 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 9 Sep 2025. 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?
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?
Sensitivity and specificity of the qualitative examination of the gastric antrum for the detection of gastric fluid volume ≥ 1.25 ml/kg in the 45° semirecumbent position (time frame: 3 minutes after the ingestion of water). 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 NCT06079268, 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 9 Sep 2025.