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

NCT02819466 | Completed

• 1 other identifier: PI2012_843_0027
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Echocardiography, Three-Dimensional

Keywords

intragastric volume; stomach; fasting

Outcome Measures

Primary Outcomes (1)

• success rate of ultrasound visualization of the stomach while fasting

  success rate of ultrasound visualization of the stomach while fasting

  Day 0

Secondary Outcomes (4)

• ultrasound visualization of the fasting stomach learning curve

  Day 0

• measured difference of antral surface area

  Day 0

• absolute error of the volume measured

  Day 0

• relative error of the volume measured

  Day 0

Study Arms (1)

volunteers

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

Device: 3D echography

Interventions

3D echography DEVICE

ultrasound visualization of the stomach in fasting patients.

volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers fasting

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Edouard SECQ, PhD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Emmanuel LORNE, MD, PhD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: June 30, 2016
• Study Start: April 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 30, 2016

Record last verified: 2016-06

Locations

FR (1)