Preoperative Evaluation of Gastric Contents by Antral Ultrasound in Diabetic Patients

NCT04668651 | Withdrawn

• 1 other identifier: 20-PP-17
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• Antral content

  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 Outcomes (5)

• Antral area

  Pre-operative, on arrival in the operating room

• Perlas grades

  Pre-operative, on arrival in the operating room

• Characteristics of diabetes

  Pre-operative, on arrival in the operating room

• Clinical signs of diabetic gastroparesis

  Pre-Anesthesia Consultation

• Perioperative respiratory complications

  Peri-operative

Study Arms (2)

diabetic

diabetic patients

Other: antral ultrasound

non diabetic

non-diabetic patients

Other: antral ultrasound

Interventions

antral ultrasound OTHER

Preoperative evaluation of gastric contents by antral ultrasound

diabetic; non diabetic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, PACA, 06000, France

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jean-Christophe ORBAN

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 16, 2020
• Study Start: January 12, 2021
• Primary Completion: April 5, 2021
• Study Completion: April 5, 2021
• Last Updated: December 3, 2025

Record last verified: 2025-11

Locations

FR (1)