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

Completed

• Conditions: Echocardiography, Three-Dimensional
• Interventions: Device: 3D echography

• Registration Number: NCT02819466
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2016-06
• Study First Submitted: 2016-06-28
• Study First Submitted QC: 2016-06-28
• Last Update Submitted: 2016-06-28
• Study First Posted: 2016-06-30
• Last Update Posted: 2016-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
volunteers	3D echography	Healthy volunteers over the age of 18 years employed by Amiens University Hospital 3D echography

Primary Outcome Measures

Name	Time	Method
success rate of ultrasound visualization of the stomach while fasting	Day 0	success rate of ultrasound visualization of the stomach while fasting

Secondary Outcome Measures

Name	Time	Method
relative error of the volume measured	Day 0	(absolute error / ingested volume) \* 100
absolute error of the volume measured	Day 0	ingested volume - intragastric volume variation
ultrasound visualization of the fasting stomach learning curve	Day 0	ultrasound visualization of the fasting stomach learning curve for each investigator
measured difference of antral surface area	Day 0	antral surface area after ingestion of fluid - fasting antral surface area

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France