Patient Satiety as an Indicator of Stomach Contents and Fluid Volume

NCT ID: NCT04884373

Last Updated: 2022-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

501 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-05

Study Completion Date

2022-01-31

Brief Summary

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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

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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.

Conditions

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Fasting Hunger

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Gastric ultrasound

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imeldaziekenhuis

OTHER

Sponsor Role lead

Responsible Party

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Peter Van de Putte

Principal investigator, MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter Van de Putte, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Imeldaziekenhuis

Locations

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Imeldaziekenhuis

Bonheiden, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 37353726 (View on PubMed)

Other Identifiers

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Imelda Anesth2021-001

Identifier Type: -

Identifier Source: org_study_id

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