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COMPLETED
NCT07638917

BBCMADE Nomogram Validation for High-Risk Gastric Content in Sedative Endoscopy

Sponsor: Fusun Gozen

View on ClinicalTrials.gov

Summary

This prospective observational study aims to validate the BBCMADE nomogram (Body Mass Index, Brain infarction, Cirrhosis, Male sex, Age, Diabetes, Esophageal reflux) for predicting high-risk gastric content in patients undergoing elective sedative gastrointestinal endoscopy in a Turkish population. Nomogram-predicted risk scores will be compared against the gold standard - endoscopically measured gastric volume and content. High-risk gastric content is defined as gastric volume ≥25 mL, pH \<2.5, or presence of solid content. The nomogram is a non-invasive, web-based, easily applicable screening tool that requires no additional training or equipment, and may contribute to safer anesthesia management by identifying high-risk patients prior to the procedure.

Official title: Prospective Validation of the BBCMADE Nomogram for Predicting High-Risk Gastric Content in Patients Undergoing Elective Sedative Gastrointestinal Endoscopy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

533

Start Date

2025-11-20

Completion Date

2026-03-31

Last Updated

2026-06-10

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

BBCMADE Nomogram

The BBCMADE nomogram (Body Mass Index, Brain infarction, Cirrhosis, Male sex, Age, Diabetes, Esophageal reflux) is applied to predict high-risk gastric content prior to elective sedative gastrointestinal endoscopy. Nomogram scores are compared against the gold standard endoscopic measurement of gastric volume and pH to prospectively validate the model in a Turkish population.

DIAGNOSTIC_TEST

Endoscopic Gastric Volume and pH Measurement

Gold-standard assessment of gastric contents is performed during endoscopy. Gastric volume ≥25 mL, pH \<2.5, or the presence of solid content is defined as high risk for pulmonary aspiration.

Locations (1)

Bursa Yüksek İhtisas Training and Research Hospital, Bursa, Türkiye

Bursa, Turkey (Türkiye)