Patient Satiety as an Indicator of Stomach Contents and Fluid Volume

Study Overview
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Brief Summary
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This research proposal aims to investigate the correlation between a) the hunger feeling as measured by a ten point scale and b) total gastric fluid volumes and content as measured with gastric PoCUS in fasted, healthy subjects > 18 of age, scheduled for elective surgery.

Detailed Description
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An ultrasound exam will be performed before induction of anaesthesia. GUS results from selected patients will be systematically acquired and assessed following an algorithm (Appendix Ia). The ultrasound results will be collected on a standardized form (Appendix IIa). The technique is performed in the supine and right lateral decubitus position (Appendix Ib) and only by anesthesiologists with sufficient experience with ultrasound and the technique. The patient will be asked to indicate his/her satiety on a predetermined ten-point scale. Patient data and satiety score will be collected on a standardized form (Appendix IIb). The scanning anaesthesiologist is blinded to the result of the questionnaire.

Official Title
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Patient Satiety as an Indicator of Stomach Contents and Fluid Volume: an Observational Prospective Study

Conditions
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Fasting, Hunger

Intervention / Treatment
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* Diagnostic Test: Gastric ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Age ≥ 18 years Fasted according to national guidelines Elective surgery ASA physical status I-II Ability to assume both supine and right lateral decubitus position. Able to understand and to sign informed consent Exclusion Criteria: - Previous esophagus and gastric surgery, hiatal hernia, gastric cancer. Pregnancy Failure of GUS (defined as failure to visualize the antrum)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fasted adult patients for elective surgery<br>Age ≥ 18 years Fasted according to national guidelines Elective surgery ASA physical status I-II Ability to assume both supine and right lateral decubitus position. Able to understand and to sign informed consent | Diagnostic Test: Gastric ultrasound<br>* An ultrasound exam will be performed before induction of anaesthesia. GUS results from selected patients will be systematically acquired and assessed following an algorithm (Appendix Ia). The ultrasound results will be collected on a standardized form (Appendix IIa). The technique is performed in the supine and right lateral decubitus position (Appendix Ib) and only by anesthesiologists with sufficient experience with ultrasound and the technique. The patient will be asked to indicate his/her satiety on a predetermined ten-point scale.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the correlation between total gastric fluid volume in millilitres and a ten-point (0-10) satiety scale. | total gastric fluid volumes are measured with gastric point-of-care ultrasound, satiety is measured with a 0 to 10 scale. Zero stands for no satiety ( very hungry, thirsty), ten stands for fully satisfied ( no hunger or thirst). | Before surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the correlation between the Perlas grading scale ( 0,1,2) and a ten-point (0-10) satiety scale. | the Perlas grading scale is a semi-quantitative scale where 0 stands for no fluid appreciated in the gastric antrum with gastric ultrasound in both the supine and right lateral decubitus postion (RLD), grade 1 stands for fluid appreciated in the RLD only, grade 2 stands for fluid appreciated in both the supine and RLD position. This will be correlated to the abovementioned satiety scale. | Before surgery | 
| the correlation between the type of gastric content ( no content, fluid content, solid content) and a ten-point (0-10) satiety scale | gastric ultrasound will reveal whether the stomach is empty, contains fluid or solid content. This will be correlated to the abovementioned satiety scale. | before surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrasonography, Gastric ultrasound