Gastric Ultrasound in Diabetic Patients

NCT06195488 | Completed

• 1 other identifier: 2022/17-1
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The American Society of Anesthesiologists (ASA) does not specify a fasting period for patients with certain comorbidities, such as diabetes, for elective surgery, and does not make a separate recommendation for surgery. The European Society of Anesthesiology (ESA) guidelines do not differentiate between diabetic patients and normal patients. Aspiration of gastric contents is a common cause of perioperative morbidity and mortality. Aspiration can cause hypoxia, bronchospasm, pneumonia, acute respiratory distress syndrome and death. The presence of food or fluid in the stomach before induction of anesthesia is one of the greatest risk factors for perioperative pulmonary aspiration. Sedation and general anesthesia suppress or inhibit physiologic mechanisms (tone of the lower esophageal sphincter and upper airway reflexes) that protect against aspiration. Because restriction of fluid and food intake before general anesthesia is vital for patient safety, Anesthesiology societies have developed guidelines for preoperative fasting. Current ASA guidelines recommend at least 2 hours fasting for clear liquids, 6 hours fasting after a light meal (toast and clear liquids) and 8 hours fasting after a high calorie or fat meal. The information obtained from gastric ultrasound allows anesthesiologists to determine the optimal timing of procedures, type of anesthesia and airway management technique.

Conditions

Gastric Emptying; Diabetes; Ultrasound

Keywords

fasting; gastric ultrasound; preoperative fasting; diabetes

Outcome Measures

Primary Outcomes (1)

• determine stomach fullness

  To evaluate residual gastric volume in diabetic patients fasting for elective surgery

  baseline (before intubation)

Secondary Outcomes (1)

• Incidence of risk factors

  during surgery

Study Arms (2)

Group D

Group Diabetic

Procedure: Gastric ultrasound

Group Control

Non-diabetic patients

Procedure: Gastric ultrasound

Interventions

Gastric ultrasound PROCEDURE

performing gastric ultrasound to determine gastric contents

Group Control; Group D

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Diabetic and non-diabetic patients aged 40-65 years undergoing ASA I-III elective surgery

You may qualify if:

• Written informed consent obtained 40-65 BMI\<40 ASA I-III Fasting for at least 8 hours Elective surgery

You may not qualify if:

• Pregnancy Upper gastrointestinal malignancy Large Hiatal Hernia Kidney failure Liver failure Opioid use Use of drugs affecting motility Previous upper abdominal surgery BMI ≥40 kg/m2 Emergency surgery Diabetic ketoacidosis Sepsis

Sponsors & Collaborators

• Zonguldak Bulent Ecevit University: lead

Study Sites (1)

Zonguldak Bülent Ecevit University Medicine Faculty

Zonguldak, Kozlu, 67600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus; Fasting

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 24, 2023
• First Posted: January 8, 2024
• Study Start: October 15, 2022
• Primary Completion: October 31, 2024
• Study Completion: January 1, 2025
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)