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

Echocardiography, Three-Dimensional Clinical Trial

— ECHO3DGASTRIQ  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02819466
• Other study ID #: PI2012_843_0027
• Status: Completed
• Phase: N/A
• First received: June 28, 2016
• Last updated: June 28, 2016
• Start date: April 2013
• Est. completion date: June 2015

Study information

• Verified date: June 2016
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Echocardiography, Three-Dimensional

Intervention

Device:
• 3D echography
ultrasound visualization of the stomach in fasting patients.

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	success rate of ultrasound visualization of the stomach while fasting	success rate of ultrasound visualization of the stomach while fasting	Day 0	No
Secondary	ultrasound visualization of the fasting stomach learning curve	ultrasound visualization of the fasting stomach learning curve for each investigator	Day 0	No
Secondary	measured difference of antral surface area	antral surface area after ingestion of fluid - fasting antral surface area	Day 0	No
Secondary	absolute error of the volume measured	ingested volume - intragastric volume variation	Day 0	No
Secondary	relative error of the volume measured	(absolute error / ingested volume) * 100	Day 0	No