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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

NCT ID: NCT02819466

Last Updated: 2016-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-06-30

Brief Summary

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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

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Conditions

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Echocardiography, Three-Dimensional

Keywords

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intragastric volume stomach fasting

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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volunteers

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

3D echography

Intervention Type DEVICE

ultrasound visualization of the stomach in fasting patients.

Interventions

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3D echography

ultrasound visualization of the stomach in fasting patients.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edouard SECQ, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Emmanuel LORNE, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Locations

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CHU Amiens

Amiens, , France

Site Status

Countries

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France

Other Identifiers

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PI2012_843_0027

Identifier Type: -

Identifier Source: org_study_id