Development and Validation of a Risk Prediction Model for Gastric Retention in Patients Undergoing Sedated Gastroscopy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorZhejiang University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years.
Patients scheduled for elective sedated gastroscopy or sedated gastro-colonoscopy.
Participant provides informed consent.
Disqualifiers
Acute upper gastrointestinal bleeding (active hematemesis, melena, or confirmed UGIB within 24h).
Emergency endoscopic procedures
Known pregnancy or lactation
Subjects deemed ineligible by investigators
Trial population
Adults scheduled for sedated gastroscopy or sedated gastro-colonoscopy.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
5,000 Participants
are grouped into 1 trial groupGroup A: Model Development Cohort, External Validation Cohort
Trial outcomes
Primary outcomes
1
Incidence of delayed gastric emptying (defined as endoscopic gastric residual volume ≥ Grade 2) assessed by standardized endoscopic grading system
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).
Time frame
Patients will be followed for the duration of hospital stay, an expected average about 2 hoursSecondary outcomes
1
Correlation between gastric residual volume (GRV) grading and Gastroparesis Cardinal Symptom Index (GCSI) scores (range: 0-20, higher scores indicate worse symptoms)
The standardized Gastroparesis Cardinal Symptom Index (GCSI) was used to quantify the following core symptoms: Nausea (frequency \& intensity): 0 (none) to 5 (severe, persistent daily). Vomiting (episode frequency): 0 (none) to 5 (≥3 times/day). Postprandial fullness (duration): 0 (none) to 5 (\>4 hours). Early satiety (food intake limitation): 0 (normal eating) to 5 (eating \<25% of usual amount). Statistical Analysis: The correlation between GRV grades (0-4) and the total GCSI score was assessed using Spearman's rank correlation coefficient.
Time frame
Patients will be followed for the duration of hospital stay, an expected average about 2 hours2
Development and validation of a simplified clinical scoring system for gastric retention risk stratification (score range: 0-10, higher scores indicate higher risk)
Development Method: Based on multivariate logistic regression results, independent predictive factors (e.g., diabetes, GLP-1 medication use) were converted into a clinical scoring system (e.g., 1-2 points per factor). Validation Process: Discrimination: The AUC (area under the curve) of the scoring system was calculated in the validation cohort (target \>0.7). Calibration: The Hosmer-Lemeshow test was used to assess the agreement between predicted and observed risks. Example Scoring Range: 0-3 points: Low risk、4-6 points: Moderate risk、7-10 points: High risk.
Time frame
Patients will be followed for the duration of hospital stay, an expected average about 2 hours3
Incidence of Gastric Retention in Patients Undergoing Gastroscopy
Time frame
Patients will be followed for the duration of hospital stay, an expected average about 2 hoursOther outcomes
1
Incidence and risk factors of anesthesia-related adverse events in patients undergoing sedated gastroscopy
Time frame
Patients will be followed for the duration of hospital stay, an expected average about 2 hoursSponsors and contacts
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Source ClinicalTrials.gov