An interventional study of Qualitative and quantitative assessment of gastric content volume with bed elevation and Qualitative and quantitative assessment of gastric content volume without bed elevation in Pulmonary Aspiration of Gastric Contents, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-03.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Basic science
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.
28 studies on the registry are indexed under Respiratory Aspiration of Gastric Contents; 6 are open to participants now.
This study's enrollment of 21 is below the median of 113 across 16 interventional studies indexed under Respiratory Aspiration of Gastric Contents.
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Exclusion Criteria:
Other: Qualitative and quantitative assessment of gastric content volume with bed elevation
Other: Qualitative and quantitative assessment of gastric content volume without bed elevation
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).
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).
Calculation of the sensitivity
Diagnostic performance of the qualitative examination of the gastric antrum in the 45° semirecumbent position.
Time frame: 3 minutes
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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
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
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
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
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
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
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
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
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
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).
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 3 minutes
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Hospices Civils de Lyon