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NCT Number: NCT04884373

Patient Satiety as an Indicator of Stomach Contents and Fluid Volume

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.

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Key information

Conditions

Fasting Behavior Feeding Behavior Hunger

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Imeldaziekenhuis

Bonheiden, 2820, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Gastric ultrasound

Diagnostic Test

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.

Primary outcomes

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

    Time frame: 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 outcomes

  1. the correlation between the Perlas grading scale ( 0,1,2) and a ten-point (0-10) satiety scale.

    Time frame: 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.

  2. the correlation between the type of gastric content ( no content, fluid content, solid content) and a ten-point (0-10) satiety scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Imeldaziekenhuis

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 13, 2021
Registry last updated
Jul 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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