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

Hopital Foch

Status: Completed

Conditions: Diabetes

Treatments: Procedure: Ultrasonic measurement of antral area

Study type: Interventional

Funder types: Other

Identifiers

NCT03036774

2015-A01997-47 (Other Identifier)

2014/30

Details and patient eligibility

About

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.

Enrollment: 245 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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245 participants in 2 patient groups

Diabetic patient

Experimental group

Description:

Diabetic patients (type 1 or type 2 diabetes) with scheduled surgery . Ultrasonic measurement of antral area

Treatment:

Procedure: Ultrasonic measurement of antral area

Non diabetic patient

Other group

Description:

Patients with scheduled surgery without history of diabetes or a current, treated or untreated, diabetic disease. Ultrasonic measurement of antral area

Treatment:

Procedure: Ultrasonic measurement of antral area