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

Diabetes Clinical Trial

— ECHODIABETE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03036774
• Other study ID #: 2014/30
• Secondary ID: 2015-A01997-47
• Status: Completed
• Phase: N/A
• Start date: February 14, 2017
• Est. completion date: February 6, 2019

Study information

• Verified date: January 2020
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: February 6, 2019
• Est. primary completion date: February 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes

Intervention

Procedure:
• Ultrasonic measurement of antral area
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 × p / 4. Antral area will correspond to the average of the three measures.

Locations

Country	Name	City	State
France	AP-HP Hopital Tenon	Paris
France	Fondation Ophtalmologique Adolphe de Rotschild	Paris
France	Hopital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Glycemia	To assess the relationship between preoperative blood glucose and gastric emptying in the diabetic population	one day
Secondary	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
Secondary	Glycated hemoglobin	To assess the relationship between glycated hemoglobin and gastric emptying in the diabetic population	one day
Secondary	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
Secondary	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
Secondary	Intraoperative hypoxemia	Evaluation of the risk of intraoperative pulmonary inhalation in both populations of patients (diabetic and non-diabetic)	one day