Baseline Gastric Volume in Diabetic vs Non-Diabetic Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Gastric Ultrasound.
- Who it may be relevant to
- Registry conditions: Gastric Volume, Preoperative Fasting, Diabetes Mellitus. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Baseline Gastric Volume Measurement in Diabetic and Non-Diabetic Patients: A Non-Inferiority Study
Overview
During the preoperative preparation process, the fasting period for anesthesia is planned according to guidelines. According to standard guidelines, a fasting period of at least 2 hours is recommended for clear liquids, at least 6 hours for light meals, and at least 8 hours for a full meal. However, it has been reported that these guidelines are valid for healthy patients. It is thought that the planned fasting periods may vary in diabetic patients due to delayed gastric emptying. This study aims to calculate gastric volume under ultrasonography guidance and compare it with fasting time.
Detailed description
Aspiration of gastric contents is the most important risk factor for pulmonary aspiration. Pulmonary aspiration is a serious perioperative complication and can lead to lung damage. The main factor in the development of this complication is the presence of a "full stomach" during induction. This can result from non-compliance with fasting protocols or delayed gastric emptying. Although the incidence of gastric content aspiration is low in patients scheduled for elective surgery, the risk factor is considered increased in diabetic patients due to delayed gastric emptying caused by autonomic dysfunction. Prior to surgery, a bedside ultrasound will be performed on the morning of the operation by an experienced anesthesiologist who is unaware of the patient's diabetes mellitus status, using a standard gastric screening protocol. Evaluation of the gastric antrum will be performed by two experienced anesthesiologists using a portable ultrasound device with a convex low-frequency (2-5 MHz) probe, first in the supine position and then in the right lateral decubitus position.
Interventions
- Procedure Gastric Ultrasound
Preoperative gastric ultrasonography will be performed to assess gastric antral cross-sectional area and estimate residual gastric volume in patients scheduled for elective surgery. The examination will be performed in the supine and right lateral decubitus positions using a low-frequency convex probe by experienced anesthesiologists.
Primary outcome measures
- Preoperative residual gastric volume [Time frame: Preoperative period]
Secondary outcome measures (2)
- Association between diabetes severity and gastric volume [Time frame: Preoperative assessment]
- Baseline gastric volume comparison [Time frame: Preoperative assessment]
Eligibility criteria
Inclusion criteria
- Ages 18-75
- ASA I-III
- BMI ≤ 40 kg/m2
Exclusion criteria
- Patients with a history of gastrointestinal surgery,
- Pregnant women,
- Patients with documented abnormalities in the upper gastrointestinal tract, such as achalasia
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Turkey (Türkiye) · 2 centers
- Kocaeli University — Kocaeli
- Sevim Cesur — Kocaeli
Identifiers
NCT: NCT07483593 · GOKAEK-2025/14/33