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

NCT07638917 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 533

Last updated 2026-06-10

No results posted yet for this study

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.

Conditions

  • Gastric Content Aspiration Risk
  • Gastrointestinal Endoscopy
  • Anesthesia Complications

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.

Sponsors & Collaborators

  • Fusun Gozen

    lead OTHER_GOV

Principal Investigators

  • Füsun Gözen · SBÜ Bursa Yüksek İhtisas Training and Research Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-20
Primary Completion
2026-02-20
Completion
2026-03-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07638917 on ClinicalTrials.gov