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

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.

Study Overview

• Status: Completed
• Conditions: Fasting; Hunger
• Intervention / Treatment: Diagnostic test: Gastric ultrasound

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 Type: Observational
• Enrollment (Actual): 501

Contacts and Locations

Study Locations

• Belgium
  • Bonheiden, Belgium, 2820
    • Imeldaziekenhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Healthy adult patients scheduled for elective surgery that fit inclusion criteria

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Fasted adult patients for elective surgery; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Imeldaziekenhuis
• Investigators: Principal Investigator: Peter Van de Putte, MD PhD, Imeldaziekenhuis

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2021
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: March 31, 2021
• First Submitted That Met QC Criteria: May 11, 2021
• First Posted (Actual): May 13, 2021

Study Record Updates

• Last Update Posted (Actual): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 24, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Ultrasonography; Gastric ultrasound
• Other Study ID Numbers: Imelda Anesth2021-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No