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

NCT07638917 | Completed

• 1 other identifier: 2024-TBEK 2025/10-09
• Study Type: observational
• Target: 533
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

gastric volume; nomogram; BBCMADE; aspiration risk; sedation; residual gastric content; preoperative assessment

Outcome Measures

Primary Outcomes (1)

• Discriminatory Performance of the BBCMADE Nomogram

  Area under the receiver operating characteristic curve (AUROC) of the BBCMADE nomogram for predicting high-risk gastric content, defined as gastric volume ≥25 mL, pH \<2.5, or presence of solid content, as confirmed by endoscopic measurement.

  At time of procedure

Study Arms (1)

Study Cohort

Patients scheduled for elective sedative gastrointestinal endoscopy. Gastric volume and pH were measured endoscopically during the procedure. Patients were classified as high or low aspiration risk based on endoscopic measurements. The BBCMADE nomogram score was calculated for each patient and compared against the endoscopic findings to validate its predictive accuracy.

Diagnostic Test: BBCMADE Nomogram; Diagnostic Test: Endoscopic Gastric Volume and pH Measurement

Interventions

BBCMADE Nomogram DIAGNOSTIC_TEST

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.

Study Cohort

Endoscopic Gastric Volume and pH Measurement DIAGNOSTIC_TEST

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.

Study Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive adult patients presenting for elective sedative gastrointestinal endoscopy at Bursa Yuksek Ihtisas Training and Research Hospital

You may qualify if:

• Age 18 years or older
• ASA physical status I-III
• Scheduled for elective gastrointestinal endoscopy under sedoanalgesia
• Deemed suitable for out-of-OR anesthesia by the anesthesiology outpatient clinic
• Provision of written informed consent

You may not qualify if:

• Age under 18 years
• Pregnancy or suspected pregnancy
• ASA physical status IV or higher
• Emergency procedures
• Unable or unwilling to provide informed consent
• History of upper airway obstructive pathology or difficult airway
• Not eligible for out-of-OR anesthesia
• Known hypersensitivity to anesthetic agents

Sponsors & Collaborators

• Fusun Gozen: lead

Study Sites (1)

Bursa Yüksek İhtisas Training and Research Hospital, Bursa, Türkiye

Bursa, Turkey (Türkiye)

Location

Related Publications (4)

• Yan Y, Jin Y, Cao Y, Chen C, Zhao X, Xia H, Yan L, Si Y, Zou J. Development and validation of a novel nomogram model to assess the risk of gastric contents in outpatients undergoing elective sedative gastrointestinal endoscopy procedures. Clin Res Hepatol Gastroenterol. 2024 Feb;48(2):102277. doi: 10.1016/j.clinre.2023.102277. Epub 2023 Dec 28.

  PMID: 38159677 BACKGROUND

• Phillips S, Liang SS, Formaz-Preston A, Stewart PA. High-risk residual gastric content in fasted patients undergoing gastrointestinal endoscopy: a prospective cohort study of prevalence and predictors. Anaesth Intensive Care. 2015 Nov;43(6):728-33. doi: 10.1177/0310057X1504300610.

  PMID: 26603797 BACKGROUND

• Friedrich K, Scholl SG, Beck S, Gotthardt D, Stremmel W, Rex DK; bng-Study-Group; Sieg A. Respiratory complications in outpatient endoscopy with endoscopist-directed sedation. J Gastrointestin Liver Dis. 2014 Sep;23(3):255-9. doi: 10.15403/jgld.2014.1121.233.kf1.

  PMID: 25267952 BACKGROUND

• Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):376-393. doi: 10.1097/ALN.0000000000001452. No abstract available.

  PMID: 28045707 BACKGROUND

MeSH Terms

Interventions

Hydrogen-Ion Concentration

Intervention Hierarchy (Ancestors)

Chemical Phenomena

Study Officials

• Füsun Gözen

  SBÜ Bursa Yüksek İhtisas Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD of Anesthesiology and Reanimation

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 10, 2026
• Study Start: November 20, 2025
• Primary Completion: February 20, 2026
• Study Completion: March 31, 2026
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)