Fasting Clinical Trial
Official title:
Patient Satiety as an Indicator of Stomach Contents and Fluid Volume: an Observational Prospective Study
Verified date | July 2022 |
Source | Imeldaziekenhuis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 501 |
Est. completion date | January 31, 2022 |
Est. primary completion date | January 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Belgium | Imeldaziekenhuis | Bonheiden |
Lead Sponsor | Collaborator |
---|---|
Imeldaziekenhuis |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 |
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