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

NCT ID: NCT03036774

Last Updated: 2020-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

245 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-14

Study Completion Date

2019-02-06

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.

Detailed Description

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Conditions

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Diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Diabetic patient

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

Group Type EXPERIMENTAL

Ultrasonic measurement of antral area

Intervention Type 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.

Non diabetic patient

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

Ultrasonic measurement of antral area

Group Type OTHER

Ultrasonic measurement of antral area

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

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


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julien Rousset, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Tenon

Marc Fischler, MD-PhD

Role: STUDY_CHAIR

Hôpital Foch

Francis Bonnet, MD-PhD

Role: STUDY_CHAIR

HopitalTenon

Locations

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Fondation Ophtalmologique Adolphe de Rotschild

Paris, , France

Site Status

AP-HP Hopital Tenon

Paris, , France

Site Status

Hopital Foch

Suresnes, , France

Site Status

Countries

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France

Other Identifiers

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2015-A01997-47

Identifier Type: OTHER

Identifier Source: secondary_id

2014/30

Identifier Type: -

Identifier Source: org_study_id

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