Patient Satiety as an Indicator of Stomach Contents and Fluid Volume

Fasting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04884373
• Other study ID #: Imelda Anesth2021-001
• Status: Completed
• Start date: June 5, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: July 2022
• Source: Imeldaziekenhuis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Fasting
• Hunger

Intervention

Diagnostic Test:
• Gastric 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.

Locations

Country	Name	City	State
Belgium	Imeldaziekenhuis	Bonheiden

Sponsors (1)

Lead Sponsor	Collaborator
Imeldaziekenhuis

Country where clinical trial is conducted

Belgium, 

Outcome

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