Development and Validation of a Risk Prediction Model for Gastric Retention in Patients Undergoing Sedated Gastroscopy: a Multicentre Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,000
- 试验地点
- 3
- 主要终点
- Incidence of delayed gastric emptying (defined as endoscopic gastric residual volume ≥ Grade 2) assessed by standardized endoscopic grading system
研究概览
简要总结
Gastric retention not only compromises the quality of endoscopic examination but also significantly increases the risk of reflux and aspiration in sedated patients. Aspiration of gastric contents represents a critical anesthesia-related complication during the perioperative period, carrying substantial implications for anesthetic management. With the growing volume of sedated gastroscopy procedures, predicting gastric retention has become an urgent clinical priority. This prospective study aims to establish a standardized gastric residual volume (GRV) grading system to evaluate both the volume of retained gastric contents and its contributing factors in patients undergoing upper gastrointestinal endoscopy. We will systematically assess the impact of demographic characteristics, comorbidities, and medication history on gastric emptying function. This study will facilitate establishment of an endoscopy-based simplified assessment system for gastric retention.
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.
- •Patients scheduled for elective sedated gastroscopy or sedated gastro-colonoscopy.
- •Participant provides informed consent.
排除标准
- •Acute upper gastrointestinal bleeding (active hematemesis, melena, or confirmed UGIB within 24h).
- •Emergency endoscopic procedures
- •Known pregnancy or lactation
- •Subjects deemed ineligible by investigators
研究组 & 干预措施
Model Development Cohort, External Validation Cohort
Model Development Cohort Definition: 3,000 patients used to identify risk factors and build the prediction mode.
External Validation Cohort Definition: 2,000 independent patients from multiple centers to test the model's accuracy.
结局指标
主要结局
Incidence of delayed gastric emptying (defined as endoscopic gastric residual volume ≥ Grade 2) assessed by standardized endoscopic grading system
时间窗: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Measurement Tool: Standardized endoscopic gastric residual volume grading system ： Grade 0：Stomach completely clean, no visible residue； Grade 1：Small amount of clear liquid (\<1.5 mL/kg or \<100 mL), no solid components； Grade 2：Liquid ≥1.5 mL/kg (or ≥100 mL) or small solid fragments (\<5 mm)； Grade 3：Large amount of liquid (\>200 mL) or significant solid residue (≥5 mm fragments) Grade 4：Visible undigested food chunks or intact food pieces Data Collection: Two physicians independently assessed gastric residue (liquid/solid), measuring volume using a graduated suction bottle, with video recordings archived for third-party review. Statistical Methods: The incidence (%) of gastric retention (≥Grade 2) was calculated. Multivariate logistic regression analyzed risk factors, and ROC curves evaluated the model's predictive performance (AUC).
次要结局
- Correlation between gastric residual volume (GRV) grading and Gastroparesis Cardinal Symptom Index (GCSI) scores (range: 0-20, higher scores indicate worse symptoms)(Patients will be followed for the duration of hospital stay, an expected average about 2 hours)
- Development and validation of a simplified clinical scoring system for gastric retention risk stratification (score range: 0-10, higher scores indicate higher risk)(Patients will be followed for the duration of hospital stay, an expected average about 2 hours)
- Incidence of Gastric Retention in Patients Undergoing Gastroscopy(Patients will be followed for the duration of hospital stay, an expected average about 2 hours)
研究者
Diansan Su
Chief Physician,Researcher
Zhejiang University