Ultrasound Measure of Gastric Volume in Diabetic and Non Diabetic Patients Before General Anesthesia

Study Overview
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Brief Summary
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The main objective is to compare the frequency of a  full stomach  in diabetic patients compared with a control population, all the patients having followed the instructions of preoperative fast.

Official Title
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Quantitative Ultrasound Assessment of Gastric Volume in Diabetic and Non Diabetic Patients Scheduled for a General Anesthesia

Conditions
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Diabetes

Intervention / Treatment
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* Procedure: Ultrasonic measurement of antral area


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged over 18 American Society of Anesthesiologists (ASA) classification 1 to 3 Needed a general anesthesia for a programmed surgical intervention Respect of instructions of the pre-operative fasting; Affiliation to the social security; Consent form signed Non inclusion Criteria: Pregnant or breastfeeding women Patients already operated or to be operated from the upper digestive tract (esophagus, stomach, duodenum) Patients treated with a prokinetic treatment and / or a level 3 analgesic Exclusion criteria Unfeasibility to ultrasound measurement of antral area Failure to observe fasting instructions

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diabetic patient<br>Diabetic patients (type 1 or type 2 diabetes) with scheduled surgery . Ultrasonic measurement of antral area | Procedure: Ultrasonic measurement of antral area<br>* Antral area is measured by ultrasound using a curvilinear abdominal probe of 2-5 MHz and a Logiq E (General Electrics) type echograph or equivalent. Ultrasound is done before the induction of general anesthesia. Three consecutive measurements of the anteroposterior (AP) and cranio-caudal (CC) diameters are performed. Antral area (CSA expressed in mm²) is show by the following formula: CSA = AP × CC × π / 4. Antral area will correspond to the average of the three measures.<br>|
| Other: Non diabetic patient<br>Patients with scheduled surgery without history of diabetes or a current, treated or untreated, diabetic disease. Ultrasonic measurement of antral area | Procedure: Ultrasonic measurement of antral area<br>* Antral area is measured by ultrasound using a curvilinear abdominal probe of 2-5 MHz and a Logiq E (General Electrics) type echograph or equivalent. Ultrasound is done before the induction of general anesthesia. Three consecutive measurements of the anteroposterior (AP) and cranio-caudal (CC) diameters are performed. Antral area (CSA expressed in mm²) is show by the following formula: CSA = AP × CC × π / 4. Antral area will correspond to the average of the three measures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with full stomach | The main objective is to compare the frequency of a full stomach in the diabetic population compared to a control population just before induction of general anesthesia. A full stomach is defined by an antral area > 340 mm2 The main objective is to compare the frequency of a full stomach in the diabetic population compared to a control population just before induction of general anesthesia. A full stomach is defined by an antral area > 340 mm2 | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemia | To assess the relationship between preoperative blood glucose and gastric emptying in the diabetic population | one day | 
| Fast duration | To compare the impact of the duration of fasting on the gastric residue in both populations of patients (diabetic and non-diabetic) | one day | 
| Glycated hemoglobin | To assess the relationship between glycated hemoglobin and gastric emptying in the diabetic population | one day | 
| Evaluation of anxiety using a numerical scale (from 0 -no anxiety- to 10 -maximal anxiety-) | To compare the impact of anxiety on the gastric residue in both populations of patients (diabetic and non-diabetic) in both populations of patients (diabetic and non-diabetic) | one day | 
| Evaluation of anxiety using a numerical scale (from 0 -no pain- to 10 -maximal pain-) | To compare the impact of pain on the gastric residue in both populations of patients (diabetic and non-diabetic) in both populations of patients (diabetic and non-diabetic) | one day | 
| Intraoperative hypoxemia | Evaluation of the risk of intraoperative pulmonary inhalation in both populations of patients (diabetic and non-diabetic) | one day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrasound, Diabetes, Gastric contents