Patient Satiety as an Indicator of Stomach Contents and Fluid Volume

NCT04884373 | Completed

• 1 other identifier: Imelda Anesth2021-001
• Study Type: observational
• Target: 501
• Locations: 1 country
• Sites: 1

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.

Conditions

Fasting; Hunger

Keywords

Ultrasonography; Gastric ultrasound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  before surgery

Study Arms (1)

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

Interventions

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.

Fasted adult patients for elective surgery

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy adult patients scheduled for elective surgery that fit inclusion criteria

You may qualify if:

• \- 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

You may not qualify if:

• \- Previous esophagus and gastric surgery, hiatal hernia, gastric cancer.
• Pregnancy
• Failure of GUS (defined as failure to visualize the antrum)

Sponsors & Collaborators

• Imeldaziekenhuis: lead

Study Sites (1)

Imeldaziekenhuis

Bonheiden, 2820, Belgium

Location

Related Publications (1)

• Van de Putte P, Herijgers A, Wallyn A, Bleeser T, Van Dijck L, Calle B, Del Jesus Sanchez Fernandez J, Dogrul F, Hendrickx E. The correlation between patient satiety sensation and total gastric fluid volume: a prospective observational study. Can J Anaesth. 2023 Aug;70(8):1307-1314. doi: 10.1007/s12630-023-02508-0. Epub 2023 Jun 23.

  PMID: 37353726 DERIVED

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Peter Van de Putte, MD PhD

  Imeldaziekenhuis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, MD PhD

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: May 13, 2021
• Study Start: June 5, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: July 26, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)