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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Procedure: Ultrasonic measurement of antral area

• Study Type: Interventional
• Enrollment (Actual): 245
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75020
    • AP-HP Hopital Tenon
  • Paris, France, 75019
    • Fondation Ophtalmologique Adolphe de Rotschild
  • Suresnes, France, 92150
    • Hôpital Foch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diabetic patient; Diabetic patients (type 1 or type 2 diabetes) with scheduled surgery . Ultrasonic measurement of antral area	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 × π / 4. Antral area will correspond to the average of the three measures.
Other: Non diabetic patient; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hopital Foch
• Investigators: Principal Investigator: Julien Rousset, MD, Hôpital Tenon; Study Chair: Marc Fischler, MD-PhD, Hôpital Foch; Study Chair: Francis Bonnet, MD-PhD, HopitalTenon

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2017
• Primary Completion (Actual): February 6, 2019
• Study Completion (Actual): February 6, 2019

Study Registration Dates

• First Submitted: January 27, 2017
• First Submitted That Met QC Criteria: January 27, 2017
• First Posted (Estimate): January 30, 2017

Study Record Updates

• Last Update Posted (Actual): January 14, 2020
• Last Update Submitted That Met QC Criteria: January 13, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Ultrasound; Diabetes; Gastric contents
• Other Study ID Numbers: 2014/30; 2015-A01997-47 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No