Recruiting soon

Gastric Volume Assessment in Diabetic and Non-Diabetic Patients Using Bedside Ultrasound

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Study Aim

This study aims to compare the residual gastric volume in diabetic and non-diabetic patients scheduled for elective surgery, using bedside ultrasound, to assess if standard preoperative fasting guidelines ensure an empty stomach in diabetic patients.

What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Diabetes Mellitus+2

+ Endocrine System Diseases

+ Metabolic Diseases

From 18 to 75 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: April 2026
See protocol details

Summary

Principal SponsorKocaeli University
Study ContactSevim CESUR, MD
Last updated: March 20, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 20, 2026

Actual date on which the first participant was enrolled.

This study focuses on understanding the risk of pulmonary aspiration, a serious complication that can occur during surgery, leading to lung damage. This happens when the contents of the stomach are inhaled into the lungs. The risk is higher when the stomach is not empty during the start of surgery, often due to not following fasting rules or delayed stomach emptying. Diabetic patients are at an increased risk because of delayed stomach emptying caused by autonomic dysfunction. The study involves diabetic and non-diabetic patients scheduled for elective surgery, aiming to compare their stomach volumes before surgery. This research is important as it could help improve safety measures for diabetic patients undergoing surgery. On the morning of the surgery, an experienced anesthesiologist, unaware of the patient's diabetic status, will perform a bedside ultrasound using a standard gastric screening protocol. Two experienced anesthesiologists will then evaluate the stomach using a portable ultrasound device, first while the patient is lying down, and then in a right side-lying position. The primary goal is to compare the residual gastric volume, or the amount of leftover content in the stomach, between diabetic and non-diabetic patients. This comparison will help determine if standard preoperative fasting guidelines are effective in ensuring an empty stomach in diabetic patients.

Official TitleBaseline Gastric Volume Measurement in Diabetic and Non-Diabetic Patients: A Non-Inferiority Study
Principal SponsorKocaeli University
Study ContactSevim CESUR, MD
Last updated: March 20, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

220 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusEndocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

3 inclusion criteria required to participate
Ages 18-75

ASA I-III

BMI <= 40 kg/m2

3 exclusion criteria prevent from participating
Patients with a history of gastrointestinal surgery

Pregnant women

Patients with documented abnormalities in the upper gastrointestinal tract, such as achalasia

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Kocaeli University

Kocaeli, Turkey (Türkiye)Open Kocaeli University in Google Maps
Suspended

Sevim Cesur

Kocaeli, Turkey (Türkiye)
Recruiting soon2 Study Centers
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