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

November 25, 2025 updated by: Centre Hospitalier Universitaire de Nice

Preoperative Evaluation of Gastric Contents by Antral Ultrasound in Diabetic Patients: a Prospective Observational Study

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
    • PACA
      • Nice, PACA, France, 06000
        • CHU de NICE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Any treated diabetic and non-diabetic patient requiring elective vascular surgery

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Preoperative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Antral area
Time Frame: Pre-operative, on arrival in the operating room
Evaluation of antral surface area between diabetic and non-diabetic patients
Pre-operative, on arrival in the operating room
Perlas grades
Time Frame: Pre-operative, on arrival in the operating room
Evaluation of Perlas grades between diabetic and non-diabetic patients
Pre-operative, on arrival in the operating room
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)
Pre-operative, on arrival in the operating room
Clinical signs of diabetic gastroparesis
Time Frame: Pre-Anesthesia Consultation
Evaluation of antral surface area and clinical signs of diabetic gastroparesis
Pre-Anesthesia Consultation
Perioperative respiratory complications
Time Frame: Peri-operative
Correlate the antral surface and perioperative respiratory complications: inhalation, pneumopathy and respiratory distress
Peri-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nice

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jean-Christophe ORBAN, Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 12, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 5, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 5, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20-PP-17

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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