Clinical and Metabolic Determinants of High Residual Gastric Volume in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Presence of a High-Risk Stomach
研究概览
简要总结
This prospective observational study will evaluate adult patients with type 2 diabetes mellitus who are scheduled for elective surgery. Immediately before preoperative gastric ultrasonography, capillary fasting blood glucose will be measured.
Gastric contents will be assessed qualitatively in the supine and right lateral decubitus positions, and residual gastric volume will be estimated using the antral cross-sectional area measured in the right lateral decubitus position.
The primary objective is to evaluate the association between fasting capillary blood glucose and the presence of a high-risk stomach. A high-risk stomach will be defined as the presence of solid gastric contents, Perlas Grade 2 gastric contents, or an estimated gastric volume greater than 1.5 mL/kg.
Secondary objectives include determining the prevalence of a high-risk stomach and evaluating its associations with demographic characteristics, diabetes-related factors, comorbidities, fasting duration, medication use, gastroparesis-related symptoms, and routine laboratory parameters.
详细描述
This is a single-center, prospective observational study involving adult patients with type 2 diabetes mellitus scheduled for elective surgery.
On the day of surgery, participants will be evaluated in the preoperative preparation area before anesthesia induction and before administration of sedative premedication. Demographic data, diabetes duration and treatment, diabetes-related complications, comorbidities, smoking status, symptoms potentially associated with gastroparesis, fasting duration, and routinely available laboratory parameters will be recorded.
Capillary fasting blood glucose will be measured immediately before gastric ultrasonography and will constitute the primary independent variable.
Gastric ultrasonography will be performed by a trained and experienced investigator using a low-frequency convex transducer. The gastric antrum will be assessed first in the supine position and then in the right lateral decubitus position. Gastric contents will be classified as empty, clear fluid, or solid content. Clear fluid findings will additionally be classified according to the Perlas grading system.
For quantitative assessment, anteroposterior and craniocaudal diameters of the gastric antrum will be measured and the antral cross-sectional area will be calculated. Estimated gastric volume will be calculated from the right lateral decubitus antral cross-sectional area and expressed both in mL and mL/kg.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Diagnosis of type 2 diabetes mellitus
- •American Society of Anesthesiologists (ASA) physical status II or III
- •Scheduled for elective surgery
- •Suitable for preoperative gastric ultrasonography
- •Provision of written informed consent
排除标准
- •Pregnancy
- •Body mass index ≥40 kg/m²
- •Emergency surgery
- •History of gastric, esophageal, or upper gastrointestinal surgery
- •Presence of a nasogastric tube
- •Known gastroparesis or gastric outlet obstruction
- •Active vomiting
- •Systemic opioid or prokinetic drug use within the previous 72 hours
- •Anatomical or technical conditions preventing adequate gastric ultrasonographic assessment
- •Impaired consciousness or inability to provide a reliable medical history
- •Refusal to participate in the study
研究组 & 干预措施
Preoperative Patients With Type 2 Diabetes Mellitus
Adult patients with type 2 diabetes mellitus, ASA physical status II or III, who are scheduled for elective surgery and undergo preoperative gastric ultrasonography and capillary fasting blood glucose measurement.
干预措施: Preoperative Gastric Ultrasonography (Diagnostic Test)
Preoperative Patients With Type 2 Diabetes Mellitus
Adult patients with type 2 diabetes mellitus, ASA physical status II or III, who are scheduled for elective surgery and undergo preoperative gastric ultrasonography and capillary fasting blood glucose measurement.
干预措施: Capillary Fasting Blood Glucose Measurement (Diagnostic Test)
结局指标
主要结局
Presence of a High-Risk Stomach
时间窗: On the day of surgery, during the preoperative assessment immediately before anesthesia induction
A high-risk stomach will be defined as the presence of at least one of the following findings on preoperative gastric ultrasonography: solid gastric contents; clear fluid visible in both the supine and right lateral decubitus positions (Perlas Grade 2); or an estimated gastric volume greater than 1.5 mL/kg.
次要结局
- Association Between High-Risk Stomach and Demographic and Clinical Characteristics(On the day of surgery, during the preoperative assessment before anesthesia induction)
- Association Between High-Risk Stomach and Metabolic and Laboratory Parameters(On the day of surgery, during the preoperative assessment before anesthesia induction)
研究者
Fatma Cigdem Ozakin
Principal Investigator, Anesthesiology and Reanimation Specialist, MD
Bakirkoy Dr. Sadi Konuk Research and Training Hospital