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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-A01997-47 | Other Identifier | ANSM |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetic patient | Experimental | Diabetic patients (type 1 or type 2 diabetes) with scheduled surgery . Ultrasonic measurement of antral area |
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| Non diabetic patient | Other | Patients with scheduled surgery without history of diabetes or a current, treated or untreated, diabetic disease. Ultrasonic measurement of antral area |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasonic measurement of antral area | Procedure | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Non inclusion Criteria:
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Julien Rousset, MD | Hôpital Tenon | Principal Investigator |
| Marc Fischler, MD-PhD | Hôpital Foch | Study Chair |
| Francis Bonnet, MD-PhD | HopitalTenon | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondation Ophtalmologique Adolphe de Rotschild | Paris | 75019 | France | |||
| AP-HP Hopital Tenon |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| 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 |
| Paris |
| 75020 |
| France |
| Hopital Foch | Suresnes | 92150 | France |