Pulmonary Aspiration of Gastric ContentsPOSIGASTNCT04097236
Body Position and Ultrasound Examination of the Gastric Antrum
A study testing Qualitative and quantitative assessment of gastric content volume with bed elevation and Qualitative and quantitative assessment of gastric content volume without bed elevation in people with Pulmonary Aspiration of Gastric Contents, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Pulmonary aspiration of gastric contents is a complication causing significant morbidity and mortality related to anesthesia. Ultrasound examination of the gastric antrum allows the detection of preoperative gastric contents contributing to the preoperative assessment of pulmonary aspiration risk. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Aspiration of Gastric Contents
- What is being tested?
- Qualitative and quantitative assessment of gastric content volume with bed elevation and Qualitative and quantitative assessment of gastric content volume without bed elevation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 27 Nov 2019to 6 Sep 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults 18 years old or older
- Last consumption of solids at least 6 hours before the start of the study, last consumption of clear fluids at least 2 hours before the start of the study
- Informed consent must have been signed.
- No significant medical history (American Society of Anesthesiologists (ASA) class 1)
Who cannot join
- Adult unable to give informed consent
- Previous gastrointestinal surgery
- Medication affecting gastric motility
- Digestive diseases, gastroparesis, diabetes mellitus with insulin
- Pregnancy or breastfeeding
- Obesity (Body Mass Index (BMI) ≥ 30 kilograms/meter² (kg/m²))
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Performance of the Ultrasound Examination of the Antrum to Detect a Full Stomach According to the Position of the Patient
Pulmonary aspiration of gastric contents is a complication causing significant morbidity and mortality related to anesthesia. Ultrasound examination of the gastric antrum allows the detection of preoperative gastric contents contributing to the preoperative assessment of pulmonary aspiration risk. In particular, this examination is based on the qualitative analysis of gastric contents performed in the supine and in the right lateral decubitus, using a qualitative score which makes it possible to discriminate a low liquid content of a large liquid volume. This score has been described in patients and volunteers installed on a bed without elevation of the upper section of the bed. However, in several studies, this qualitative score has been achieved in the 45° semirecumbent position, which may have affected the diagnostic performance of the examination thus performed, as suggested by the results of a study recently conducted by the investigating team. This study therefore aims to compare the diagnostic performance of the qualitative analysis of the gastric antrum performed in the supine and the right lateral decubitus for the diagnosis of gastric volumes higher than 50 ml and 100 ml, according to the bed angle: 45 ° elevation or no elevation of the upper section of the bed.
- Conditions
- Pulmonary Aspiration of Gastric Contents
- Being tested
- Qualitative and quantitative assessment of gastric content volume with bed elevation, Qualitative and quantitative assessment of gastric content volume without bed elevation
- Medical subject headings
- Respiratory Aspiration of Gastric Contents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative and quantitative assessment of gastric content volume with bed elevationOther
Ultrasound examination of the gastric antrum are performed 3 minutes after the ingestion of a volume of water (either 0, 50, 100, 150, or 200 milliliters (ml), determined by randomization). The procedure is repeated three times (three different volumes, the same volumes for each session with randomized order for each session).
Qualitative and quantitative assessment of gastric content volume without bed elevationOther
Ultrasound examination of the gastric antrum are performed 3 minutes after the ingestion of a volume of water (either 0, 50, 100, 150, or 200 milliliters (ml), determined by randomization). The procedure is repeated three times (three different volumes, the same volumes for each session with randomized order for each session).
| Study group | Role | What they receive |
|---|---|---|
| 45° semirecumbent position | Active comparator | Not described Receives: Other: Qualitative and quantitative assessment of gastric content volume with bed elevation |
| No elevation of the upper section of the bed | Active comparator | Not described Receives: Other: Qualitative and quantitative assessment of gastric content volume without bed elevation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculation of the sensitivity
Diagnostic performance of the qualitative examination of the gastric antrum in the 45° semirecumbent position.
Measured: 3 minutes
Secondary outcomes (16)
Calculation of the specificity
Diagnostic performance of the qualitative examination of the gastric antrum in full supine/right lateral decubitus position.
The diagnostic performance will be calculated according to the results of the qualitative assessments performed 3 minutes after the ingestion of water (either 0, 50, 100, 150 or 200 milliliters (ml)) by the volunteers.
Measured: 3 minutes
Calculation of the positive predictive value,
Diagnostic performance of the qualitative examination of the gastric antrum in full supine/right lateral decubitus position. The diagnostic performance will be calculated according to the results of the qualitative assessments performed 3 minutes after the ingestion of water (either 0, 50, 100, 150 or 200 milliliters (ml)) by the volunteers.
Measured: 3 minutes
Calculation of the negative predictive value
Diagnostic performance of the qualitative examination of the gastric antrum in full supine/right lateral decubitus position. The diagnostic performance will be calculated according to the results of the qualitative assessments performed 3 minutes after the ingestion of water (either 0, 50, 100, 150 or 200 milliliters (ml)) by the volunteers.
Measured: 3 minutes
Calculation of the positive and negative likelihood ratio.
Diagnostic performance of the qualitative examination of the gastric antrum in full supine/right lateral decubitus position. The diagnostic performance will be calculated according to the results of the qualitative assessments performed 3 minutes after the ingestion of water (either 0, 50, 100, 150 or 200 milliliters (ml)) by the volunteers.
Measured: 3 minutes
Diagnostic performance of the qualitative examination of the gastric antrum for the detection of gastric fluid volume ≥ 0.8 milliliters/kilogram (ml/kg) in the full supine and right lateral decubitus position and in the 45° semirecumbent position
Calculation of the sensitivity. The diagnostic performance will be calculated according to the results of the qualitative assessments performed 3 minutes after the ingestion of water (either 0, 50, 100, 150 or 200 milliliters (ml)) by the volunteers
Measured: 3 minutes
Diagnostic performance of the qualitative examination of the gastric antrum for the detection of gastric fluid volume ≥ 0.8 milliliters/kilogram (ml/kg) in the full supine and right lateral decubitus position and in the 45° semirecumbent position
Calculation of the specificity The diagnostic performance will be calculated according to the results of the qualitative assessments performed 3 minutes after the ingestion of water (either 0, 50, 100, 150 or 200 milliliters (ml)) by the volunteers
Measured: 3 minutes
Diagnostic performance of the qualitative examination of the gastric antrum for the detection of gastric fluid volume ≥ 0.8 milliliters/kilogram (ml/kg) in the full supine and right lateral decubitus position and in the 45° semirecumbent position
Calculation of the positive predictive value negative The diagnostic performance will be calculated according to the results of the qualitative assessments performed 3 minutes after the ingestion of water (either 0, 50, 100, 150 or 200 milliliters (ml)) by the volunteers
Measured: 3 minutes
Diagnostic performance of the qualitative examination of the gastric antrum for the detection of gastric fluid volume ≥ 0.8 milliliters/kilogram (ml/kg) in the full supine and right lateral decubitus position and in the 45° semirecumbent position
Calculation of the negative predictive value. The diagnostic performance will be calculated according to the results of the qualitative assessments performed 3 minutes after the ingestion of water (either 0, 50, 100, 150 or 200 milliliters (ml)) by the volunteers
Measured: 3 minutes
Diagnostic performance of the qualitative examination of the gastric antrum for the detection of gastric fluid volume ≥ 0.8 milliliters/kilogram (ml/kg) in the full supine and right lateral decubitus position and in the 45° semirecumbent position
Calculation of the positive and negative likelihood ratio. The diagnostic performance will be calculated according to the results of the qualitative assessments performed 3 minutes after the ingestion of water (either 0, 50, 100, 150 or 200 milliliters (ml)) by the volunteers
Measured: 3 minutes
Cut-off value for antral area measured in the supine position (semirecumbent or full supine position) associated with the best diagnostic performance for the detection of a gastric volume ≥1.5 milliliters/kilogram (ml/kg).
The cut-off value will be calculated according to the results of the measurements performed 3 minutes after the ingestion of water (either 0, 50, 100, 150 or 200 milliliters (ml)) by the volunteers
Measured: 3 minutes
Diagnostic performance of the qualitative examination of the gastric antrum in the semirecumbent position without bed elevation
Calculation of the sensitivity. The diagnostic performance will be calculated according to the results of the qualitative and quantitative assessments performed 3 minutes after the ingestion of water (either 0, 50, 100, 150 or 200 milliliters (ml)) by the volunteers
Measured: 3 minutes
Diagnostic performance of the qualitative examination of the gastric antrum in the semirecumbent position without bed elevation
Calculation of the specificity. The diagnostic performance will be calculated according to the results of the qualitative and quantitative assessments performed 3 minutes after the ingestion of water (either 0, 50, 100, 150 or 200 milliliters (ml)) by the volunteers
Measured: 3 minutes
Diagnostic performance of the qualitative examination of the gastric antrum in the semirecumbent position without bed elevation
Calculation of the positive predictive value. The diagnostic performance will be calculated according to the results of the qualitative and quantitative assessments performed 3 minutes after the ingestion of water (either 0, 50, 100, 150 or 200 milliliters (ml)) by the volunteers
Measured: 3 minutes
Diagnostic performance of the qualitative examination of the gastric antrum in the semirecumbent position without bed elevation
Calculation of the negative predictive value. The diagnostic performance will be calculated according to the results of the qualitative and quantitative assessments performed 3 minutes after the ingestion of water (either 0, 50, 100, 150 or 200 milliliters (ml)) by the volunteers
Measured: 3 minutes
Diagnostic performance of the qualitative examination of the gastric antrum in the semirecumbent position without bed elevation
Calculation of the positive and negative likelihood ratio. The diagnostic performance will be calculated according to the results of the qualitative and quantitative assessments performed 3 minutes after the ingestion of water (either 0, 50, 100, 150 or 200 milliliters (ml)) by the volunteers
Measured: 3 minutes
Mathematical model for the calculation of the gastric fluid volume
Multiple linear regression including the antral surface measured in right lateral decubitus and the age, height, weight of the volunteer. The mathematical model will be built according to the results of the measurements performed 3 minutes after the ingestion of water (either 0, 50, 100, 150 or 200 milliliters (ml)) by the volunteers
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start27 Nov 2019
- Primary completion6 Sep 2021
- Study completion6 Sep 2021
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 Pulmonary Aspiration of Gastric ContentsStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie Barnoud, Dr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04097236
- Sponsor's protocol ID
- 69HCL19_0244
- Other IDs
- 2019-A01333-54
- Acronym
- POSIGAST
- Status last verified
- Aug 2025
- First submitted
- 15 May 2019
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bouvet L, Cordoval J, Barnoud S, Berlier J, Desgranges FP, Chassard D. Diagnostic performance of qualitative ultrasound assessment for the interpretation of point-of-care gastric ultrasound to detect high gastric fluid volume: A prospective randomized crossover study. J Clin Anesth. 2022 Oct;81:110919. doi: 10.1016/j.jclinane.2022.110919. Epub 2022 Jul 2.
PubMed 35792453
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of the Ultrasound Examination of the Antrum to Detect a Full Stomach According to the Position of the Patient
- ClinicalTrials.gov ID
- NCT04097236
- Acronym / sponsor ID
- POSIGAST / 69HCL19_0244
- Conditions
- Pulmonary Aspiration of Gastric Contents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 27 Nov 2019 (actual)
- Primary completion
- 6 Sep 2021 (actual)
- Study completion
- 6 Sep 2021 (actual)
- First posted
- 20 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.
Pulmonary aspiration of gastric contents is a complication causing significant morbidity and mortality related to anesthesia. Ultrasound examination of the gastric antrum allows the detection of preoperative gastric contents contributing to the preoperative assessment of pulmonary aspiration risk. In particular, this examination is based on the qualitative analysis of gastric contents performed in the supine and in the right lateral decubitus, using a qualitative score which makes it possible to discriminate a low liquid content of a large liquid volume. This score has been described in patients and volunteers installed on a bed without elevation of the upper section of the bed. However, in several studies, this qualitative score has been achieved in the 45° semirecumbent position, which may have affected the diagnostic performance of the examination thus performed, as suggested by the results of a study recently conducted by the investigating team. This study therefore aims to compare the diagnostic performance of the qualitative analysis of the gastric antrum performed in the supine and the right lateral decubitus for the diagnosis of gastric volumes higher than 50 ml and 100 ml, according to the bed angle: 45 ° elevation or no elevation of the upper section of the bed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 45° semirecumbent position | Active comparator | Other: Qualitative and quantitative assessment of gastric content volume with bed elevation |
| No elevation of the upper section of the bed | Active comparator | Other: Qualitative and quantitative assessment of gastric content volume without bed elevation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults 18 years old or older
- Last consumption of solids at least 6 hours before the start of the study, last consumption of clear fluids at least 2 hours before the start of the study
- Informed consent must have been signed.
- No significant medical history (American Society of Anesthesiologists (ASA) class 1)
Key exclusion criteria (6 listed)
- Adult unable to give informed consent
- Previous gastrointestinal surgery
- Medication affecting gastric motility
- Digestive diseases, gastroparesis, diabetes mellitus with insulin
- Pregnancy or breastfeeding
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 |
|---|---|---|
| Qualitative and quantitative assessment of gastric content volume with bed elevationUltrasound examination of the gastric antrum are performed 3 minutes after the ingestion of a volume of water (either 0, 50, 100, 150, or 200 milliliters (ml), determined by randomization). The procedure is repeated three times (three different volumes, the same volumes for each session with randomized order for each session). | Other | 45° semirecumbent position |
| Qualitative and quantitative assessment of gastric content volume without bed elevationUltrasound examination of the gastric antrum are performed 3 minutes after the ingestion of a volume of water (either 0, 50, 100, 150, or 200 milliliters (ml), determined by randomization). The procedure is repeated three times (three different volumes, the same volumes for each session with randomized order for each session). | Other | No elevation of the upper section of the bed |
Primary outcome
Calculation of the sensitivity
Time frame: 3 minutes
Diagnostic performance of the qualitative examination of the gastric antrum in the 45° semirecumbent position.
16 secondary outcomes
Calculation of the specificity
Time frame: 3 minutes
Calculation of the positive predictive value,
Time frame: 3 minutes
Calculation of the negative predictive value
Time frame: 3 minutes
Calculation of the positive and negative likelihood ratio.
Time frame: 3 minutes
Diagnostic performance of the qualitative examination of the gastric antrum for the detection of gastric fluid volume ≥ 0.8 milliliters/kilogram (ml/kg) in the full supine and right lateral decubitus position and in the 45° semirecumbent position
Time frame: 3 minutes
Diagnostic performance of the qualitative examination of the gastric antrum for the detection of gastric fluid volume ≥ 0.8 milliliters/kilogram (ml/kg) in the full supine and right lateral decubitus position and in the 45° semirecumbent position
Time frame: 3 minutes
Diagnostic performance of the qualitative examination of the gastric antrum for the detection of gastric fluid volume ≥ 0.8 milliliters/kilogram (ml/kg) in the full supine and right lateral decubitus position and in the 45° semirecumbent position
Time frame: 3 minutes
Diagnostic performance of the qualitative examination of the gastric antrum for the detection of gastric fluid volume ≥ 0.8 milliliters/kilogram (ml/kg) in the full supine and right lateral decubitus position and in the 45° semirecumbent position
Time frame: 3 minutes
Diagnostic performance of the qualitative examination of the gastric antrum for the detection of gastric fluid volume ≥ 0.8 milliliters/kilogram (ml/kg) in the full supine and right lateral decubitus position and in the 45° semirecumbent position
Time frame: 3 minutes
Cut-off value for antral area measured in the supine position (semirecumbent or full supine position) associated with the best diagnostic performance for the detection of a gastric volume ≥1.5 milliliters/kilogram (ml/kg).
Time frame: 3 minutes
Diagnostic performance of the qualitative examination of the gastric antrum in the semirecumbent position without bed elevation
Time frame: 3 minutes
Diagnostic performance of the qualitative examination of the gastric antrum in the semirecumbent position without bed elevation
Time frame: 3 minutes
Diagnostic performance of the qualitative examination of the gastric antrum in the semirecumbent position without bed elevation
Time frame: 3 minutes
Diagnostic performance of the qualitative examination of the gastric antrum in the semirecumbent position without bed elevation
Time frame: 3 minutes
Diagnostic performance of the qualitative examination of the gastric antrum in the semirecumbent position without bed elevation
Time frame: 3 minutes
Mathematical model for the calculation of the gastric fluid volume
Time frame: 3 minutes
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 3 Sep 2025.
- Results publication: PubMed 35792453Bouvet L, Cordoval J, Barnoud S, Berlier J, Desgranges FP, Chassard D. Diagnostic performance of qualitative ultrasound assessment for the interpretation of point-of-care gastric ultrasound to detect high gastric fluid volume: A prospective randomized crossover study. J Clin Anesth. 2022 Oct;81:110919. doi: 10.1016/j.jclinane.2022.110919. Epub 2022 Jul 2.
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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.
Sophie Barnoud, Dr principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qualitative and quantitative assessment of gastric content volume with bed elevation and Qualitative and quantitative assessment of gastric content volume without bed elevation in people with Pulmonary Aspiration of Gastric Contents, 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 4 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 3 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?
Calculation of the sensitivity (time frame: 3 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 NCT04097236, 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 3 Sep 2025.