Patient Satiety as an Indicator of Stomach Contents and Fluid Volume

Completed

• Conditions: Hunger; Fasting
• Interventions: Diagnostic Test: Gastric ultrasound

• Registration Number: NCT04884373
• Lead Sponsor: Imeldaziekenhuis

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.

Study Timeline

• Study First Submitted: 2021-03-31
• Study First Submitted QC: 2021-05-11
• Study First Posted: 2021-05-13
• Study Start: 2021-06-05
• Primary Completion: 2022-01-31
• Study Completion: 2022-01-31
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-24
• Last Update Posted: 2022-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 501

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fasted adult patients for elective surgery	Gastric ultrasound	* 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

Primary Outcome Measures

Name	Time	Method
the correlation between total gastric fluid volume in millilitres and a ten-point (0-10) satiety scale.	Before surgery	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Imeldaziekenhuis; 🇧🇪 Bonheiden, Belgium