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Preoperative Evaluation of Gastric Contents by Antral Ultrasound in Diabetic Patients (PEGASED)

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ClinicalTrials.gov Identifier: NCT04668651
Recruitment Status : Recruiting
First Posted : December 16, 2020
Last Update Posted : January 19, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Study Description
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Brief Summary:

Gastric aspiration represents the third cause of perioperative death in France. In scheduled surgery, it can be prevented by preoperative fasting. The French and American guidelines recommend a fasting of 2 hours for clear liquids and 6 hours for solid food. However, these durations could be too short in case of delayed gastric emptying due to medications of diabetes for example. This latter condition has an increasing incidence. Numerous complications are related to chronic hyperglycemia including delayed gastric emptying also known as gastroparesis. Around one third of diabetic patients presents this complication.

Gastric ultrasound represents a non-invasive method to explore the stomach. It allows the qualitative and quantitative evaluations of gastric content.

As diabetic patients present a risk of non-empty stomach despite fasting,investigators decided to conduct a prospective observational study compare the appearance of the stomach assessed by ultrasonography between diabetic and non-diabetic patients before scheduled surgery


Condition or disease Intervention/treatment
Diabetes Other: antral ultrasound

Detailed Description:

Gastric aspiration represents the third cause of perioperative death in France. The physiopathology of this complication is multifactorial, implying among other things the lack of respect for the rules of preoperative fasting, especially during emergency operations. Indeed, the presence of food content in the stomach, combined with the decrease in the pressure of the lower sphincter of the esophagus and the protection of the upper airways during the induction of general anesthesia, is accompanied by a significant increase in the risk of regurgitation and inhalation of gastric contents.

There are more than 3 million diabetic patients in France, with an increase in prevalence of more than 5% per year. The main digestive disorder linked to autonomic neuropathy in the diabetic subject is represented by gastroparesis, characterized by a delay in gastric emptying without mechanical impediment, associated with signs of abnormal gastric motility. Gastroparesis results from an impairment of the neurovegetative regulation of the stomach related to exposure to prolonged hyperglycemia. It is estimated that approximately 1/3 of diabetics are affected.

Ultrasound measurement of the antral section area was originally described for the evaluation and study of gastric emptying in obstetrics and medicine. Several studies have shown the interest of this measurement for the evaluation of gastric content and volume in the preoperative period. The antral ultrasound makes it possible to discriminate a "full" stomach from an "empty" stomach with excellent performance. Thus, investigators have at our disposal a simple and non-invasive tool to evaluate in real time the state of gastric vacuity in patients in the operating room.

In practice, ultrasound measurement of the antral section area is performed using an ultrasound scanner equipped with a 2-5 MHz frequency probe. The diameters (longitudinal D1 and anteroposterior D2) of the antrum are measured in the sagittal plane passing through the abdominal aorta and the left lobe of the liver. The value of the antral cross-sectional area is given by the formula: antral area = π x D1 x D2 / 4. This ultrasound measurement of the antral cross-sectional area is commonly performed in the operating room and is recommended in some anesthesia reference books. Several mathematical models have been constructed, in adults and children, to calculate the volume of gastric contents based on this measurement of anal area, with satisfactory accuracy (R² = 0.72 to 0.86). Gastric ultrasound is easily performed at the patient's bedside, before general or local anesthesia, and its use has recently been described to study gastric emptying.

Investigators would like to evaluate the gastric content in diabetics in the perioperative period.

Study Design
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Study Type : Observational
Estimated Enrollment : 52 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Preoperative Evaluation of Gastric Contents by Antral Ultrasound in Diabetic Patients: a Prospective Observational Study
Actual Study Start Date : December 21, 2020
Estimated Primary Completion Date : March 15, 2021
Estimated Study Completion Date : March 21, 2021
Groups and Cohorts
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Group/Cohort Intervention/treatment
diabetic
diabetic patients
 Other: antral ultrasound
Preoperative evaluation of gastric contents by antral ultrasound
non diabetic
non-diabetic patients
 Other: antral ultrasound
Preoperative evaluation of gastric contents by antral ultrasound


Outcome Measures
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Primary Outcome Measures :
  1. Antral content [ Time Frame: Preoperative ]
    Evaluation of antral content according to the Perlas classification (0, 1 or 2) and antral surface area between diabetic and non-diabetic patients.


Secondary Outcome Measures :
  1. Antral area [ Time Frame: Pre-operative, on arrival in the operating room ]
    Evaluation of antral surface area between diabetic and non-diabetic patients

  2. Perlas grades [ Time Frame: Pre-operative, on arrival in the operating room ]
    Evaluation of Perlas grades between diabetic and non-diabetic patients

  3. Characteristics of diabetes [ Time Frame: Pre-operative, on arrival in the operating room ]
    Correlate the antral surface area and characteristics of diabetes (type, duration, glycosylated hemoglobin results)

  4. Clinical signs of diabetic gastroparesis [ Time Frame: Pre-Anesthesia Consultation ]
    Evaluation of antral surface area and clinical signs of diabetic gastroparesis

  5. Perioperative respiratory complications [ Time Frame: Peri-operative ]
    Correlate the antral surface and perioperative respiratory complications: inhalation, pneumopathy and respiratory distress


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any treated diabetic and non-diabetic patient requiring elective vascular surgery
Criteria

Inclusion Criteria:

  • Age > 18 years old
  • Any treated diabetic and non-diabetic patient requiring elective vascular surgery who has agreed to participate in the study (consent form obtained).
  • Affiliation or beneficiary of social security.

Exclusion Criteria:

  • Pregnant woman
  • Persons of full age protected by law
  • Patient Refusal
  • Patient deprived of liberty
  • History of gastric surgery
  • Any situation requiring urgent treatment that is not compatible with the performance of a gastric ultrasound scan.
Contacts and Locations
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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): NCT04668651


Contacts
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Contact: Jean-Christophe ORBAN 0492033624 ext +33 orban.jc@chu-nice.fr
Contact: Lyor Maillard maillard.l@chu-nice.fr

Locations
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France
CHU de Nice Recruiting
Nice, Paca, France, 06000
Contact: Jean-Christophe ORBAN    0492033624 ext +33    orban.jc@chu-nice.fr   
Contact: Lyor MAILLARD       maillard.l@chu-nice.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
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Principal Investigator: Jean-Christophe ORBAN Centre Hospitalier Universitaire de Nice
More Information
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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT04668651    
Other Study ID Numbers: 20-PP-17
First Posted: December 16, 2020    Key Record Dates
Last Update Posted: January 19, 2021
Last Verified: January 2021

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