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Completed

NCT Number: NCT03036774

Ultrasound Measure of Gastric Volume in Diabetic and Non Diabetic Patients Before 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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AP-HP Hopital Tenon, Paris, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasonic measurement of antral area

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.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study title

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

Acronym: ECHODIABETE

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 30, 2017
Registry last updated
Jan 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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