FastingNCT04884373
Patient Satiety as an Indicator of Stomach Contents and Fluid Volume
An observational study of Fasting and Hunger, run by Imeldaziekenhuis at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- What is being tested?
- Gastric ultrasound
- How many people
- 501 participants
- Where
- 1 siteBelgium
- Study dates
- 5 Jun 2021to 31 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Healthy adult patients scheduled for elective surgery that fit inclusion criteria
Who may be able to join
- - 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
Who cannot join
- - Previous esophagus and gastric surgery, hiatal hernia, gastric cancer.
- Pregnancy
- Failure of GUS (defined as failure to visualize the antrum)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Gastric ultrasound
- Keywords
- Ultrasonography, Gastric ultrasound
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric ultrasoundDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Gastric ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Before surgery
Secondary outcomes (2)
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.
Measured: 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.
Measured: before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start5 Jun 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FastingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 501 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imeldaziekenhuis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Van de Putte, Imeldaziekenhuis
- Investigators
- Peter Van de Putte, MD PhD, Principal investigator, Imeldaziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884373
- Sponsor's protocol ID
- Imelda Anesth2021-001
- Status last verified
- Jul 2022
- First submitted
- 31 Mar 2021
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37353726
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satiety as an Indicator of Stomach Contents and Fluid Volume: an Observational Prospective Study
- ClinicalTrials.gov ID
- NCT04884373
- Acronym / sponsor ID
- Imelda Anesth2021-001
- Keywords
- Ultrasonography, Gastric ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- ImeldaziekenhuisUniversity, hospital or other
- Study start
- 5 Jun 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 13 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fasted adult patients for elective surgery | – | Diagnostic Test: 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adult patients scheduled for elective surgery that fit inclusion criteria
Key inclusion criteria (6 listed)
- - 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.
Key exclusion criteria (3 listed)
- - Previous esophagus and gastric surgery, hiatal hernia, gastric cancer.
- Pregnancy
- Failure of GUS (defined as failure to visualize the antrum)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric ultrasoundAn 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. | Diagnostic test | Fasted adult patients for elective surgery |
Primary outcome
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).
2 secondary outcomes
the correlation between the Perlas grading scale ( 0,1,2) and a ten-point (0-10) satiety scale.
Time frame: Before surgery
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Derived from this study: PubMed 37353726Van 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Van de Putte, MD PhD principal investigator
Imeldaziekenhuis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fasting and Hunger, run by Imeldaziekenhuis at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the correlation between total gastric fluid volume in millilitres and a ten-point (0-10) satiety scale. (time frame: Before surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04884373, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.