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

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ClinicalTrials.gov Identifier: NCT03036774
Recruitment Status : Completed
First Posted : January 30, 2017
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Hopital Foch

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Procedure: Ultrasonic measurement of antral area Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 245 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Other
Official Title: Quantitative Ultrasound Assessment of Gastric Volume in Diabetic and Non Diabetic Patients Scheduled for a General Anesthesia
Actual Study Start Date : February 14, 2017
Actual Primary Completion Date : February 6, 2019
Actual Study Completion Date : February 6, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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.


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.





Primary Outcome Measures :
  1. Number of patients with full stomach [ Time Frame: one day ]

    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



Secondary Outcome Measures :
  1. Glycemia [ Time Frame: one day ]
    To assess the relationship between preoperative blood glucose and gastric emptying in the diabetic population

  2. Fast duration [ Time Frame: one day ]
    To compare the impact of the duration of fasting on the gastric residue in both populations of patients (diabetic and non-diabetic)

  3. Glycated hemoglobin [ Time Frame: one day ]
    To assess the relationship between glycated hemoglobin and gastric emptying in the diabetic population

  4. Evaluation of anxiety using a numerical scale (from 0 -no anxiety- to 10 -maximal anxiety-) [ Time Frame: one day ]
    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)

  5. Evaluation of anxiety using a numerical scale (from 0 -no pain- to 10 -maximal pain-) [ Time Frame: one day ]
    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)

  6. Intraoperative hypoxemia [ Time Frame: one day ]
    Evaluation of the risk of intraoperative pulmonary inhalation in both populations of patients (diabetic and non-diabetic)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036774


Locations
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France
Fondation Ophtalmologique Adolphe de Rotschild
Paris, France, 75019
AP-HP Hopital Tenon
Paris, France, 75020
Hopital Foch
Suresnes, France, 92150
Sponsors and Collaborators
Hopital Foch
Investigators
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Principal Investigator: Julien Rousset, MD Hôpital Tenon
Study Chair: Marc Fischler, MD-PhD Hôpital Foch
Study Chair: Francis Bonnet, MD-PhD HopitalTenon

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Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT03036774     History of Changes
Other Study ID Numbers: 2014/30
2015-A01997-47 ( Other Identifier: ANSM )
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hopital Foch:
Gastric contents
Ultrasound
Diabetes

Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs