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NCT Number: NCT02819466

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens

Amiens, 80054, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

3D echography

Device

ultrasound visualization of the stomach in fasting patients.

Primary outcomes

  1. success rate of ultrasound visualization of the stomach while fasting

    Time frame: Day 0

    success rate of ultrasound visualization of the stomach while fasting

Secondary outcomes

  1. ultrasound visualization of the fasting stomach learning curve

    Time frame: Day 0

    ultrasound visualization of the fasting stomach learning curve for each investigator

  2. measured difference of antral surface area

    Time frame: Day 0

    antral surface area after ingestion of fluid - fasting antral surface area

  3. absolute error of the volume measured

    Time frame: Day 0

    ingested volume - intragastric volume variation

  4. relative error of the volume measured

    Time frame: Day 0

    (absolute error / ingested volume) * 100

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study 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

Acronym: ECHO3DGASTRIQ

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 30, 2016
Registry last updated
Jun 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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