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Patient Satiety as an Indicator of Stomach Contents and Fluid Volume

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04884373
Enrollment
501
Registered
2021-05-13
Start date
2021-06-05
Completion date
2022-01-31
Last updated
2022-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fasting, Hunger

Keywords

Ultrasonography, Gastric ultrasound

Brief summary

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

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.

Interventions

DIAGNOSTIC_TESTGastric ultrasound

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.

Sponsors

Imeldaziekenhuis
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
the correlation between total gastric fluid volume in millilitres and a ten-point (0-10) satiety scale.Before surgerytotal 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).

Secondary

MeasureTime frameDescription
the correlation between the Perlas grading scale ( 0,1,2) and a ten-point (0-10) satiety scale.Before surgerythe 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.
the correlation between the type of gastric content ( no content, fluid content, solid content) and a ten-point (0-10) satiety scalebefore surgerygastric ultrasound will reveal whether the stomach is empty, contains fluid or solid content. This will be correlated to the abovementioned satiety scale.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026