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Visualization of the Stomach During Fasting and Measurement of Intragastric Volume After Ingestion of Fluid: Feasibility and Application of Three Dimensional Ultrasound in Healthy Subjects

Visualization of the Stomach During Fasting and Measurement of Intragastric Volume After Ingestion of Fluid: Feasibility and Application of Three Dimensional Ultrasound in Healthy Subjects. ECHO3DGASTRIQUE Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02819466
Acronym
ECHO3DGASTRIQ
Enrollment
6
Registered
2016-06-30
Start date
2013-04-30
Completion date
2015-06-30
Last updated
2016-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Echocardiography, Three-Dimensional

Keywords

intragastric volume, stomach, fasting

Brief summary

Aspiration pneumonia is a dreaded complication of anaesthesia because of its prevalence (1/3,886 cases in elective anaesthesia and 1/895 cases in emergency settings) and its high morbidity and mortality (3 to 9%). This chemical and/or infectious pneumonia is secondary to passage of the gastric contents into the unprotected upper airways during general anaesthesia. The prognosis depends on three factors: the presence of food debris, and the acidity and volume of the gastric contents. To prevent this complication, the French society of anaesthesia and intensive care recommends preoperative fasting rules and, in patients presenting risk factors for aspiration, the use of antacids and rapid sequence intubation. This preventive strategy is associated with certain adverse events: deferred operative procedures, discomfort and hypoglycaemia secondary to fasting, more frequent anaphylactic complications, and memory of anaesthetic induction. Over recent years, ultrasound has become more widely used by anaesthetists for local anaesthesia, vascular catheterization, haemodynamic monitoring and, more recently, 2D ultrasound estimation of intragastric volume. However, 2D ultrasound estimation of intragastric volume presents several limitations: because of the complex shape of the stomach, this technique requires a long learning curve and the measured volume is poorly correlated with reference techniques (MRI and 99Tc scintigraphy). Two studies have recently measured intragastric volume by three dimensional ultrasound with promising results.

Interventions

DEVICE3D echography

ultrasound visualization of the stomach in fasting patients.

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Healthy volunteers over the age of 18 years employed by Amiens University Hospital and covered by French national health insurance. * Fasting (last meal \> 6 hours and last drink of water, tea or coffee \> 2 hours) * Signature of the free and informed written consent form.

Exclusion criteria

* Pregnant woman. * Presence of diseases or treatments that alter (slow or accelerate) gastric emptying. * Presence of swallowing disorders. * History of gastric or supramesocolic surgery.

Design outcomes

Primary

MeasureTime frameDescription
success rate of ultrasound visualization of the stomach while fastingDay 0success rate of ultrasound visualization of the stomach while fasting

Secondary

MeasureTime frameDescription
ultrasound visualization of the fasting stomach learning curveDay 0ultrasound visualization of the fasting stomach learning curve for each investigator
measured difference of antral surface areaDay 0antral surface area after ingestion of fluid - fasting antral surface area
absolute error of the volume measuredDay 0ingested volume - intragastric volume variation
relative error of the volume measuredDay 0(absolute error / ingested volume) \* 100

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026