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

June 5, 2026 updated by: Fusun Gozen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pulmonary aspiration of gastric contents accounts for 10-30% of anesthesia-related deaths. Standard fasting guidelines do not guarantee adequate gastric emptying in all patients. The BBCMADE nomogram, developed and validated by Yan et al. (2024) in a Chinese population, demonstrated high discriminatory power for predicting high-risk gastric residual content in outpatients undergoing sedative GI endoscopy. This study will prospectively evaluate its validity in a Turkish population (n=533).

The seven predictor variables (BMI, history of cerebral infarction, cirrhosis, male sex, age, diabetes, gastroesophageal reflux) will be recorded preoperatively and entered into the web-based nomogram interface. Endoscopic gastric volume measurement will serve as the gold standard. Discriminatory performance will be assessed by AUROC. Secondary analyses will include sensitivity, specificity, PPV, NPV, and subgroup analyses.

Sample size: 533 patients (prevalence ~13%, α=0.05, power=95%, 15% dropout allowance; calculated using G*Power 3).

Study Type

Observational

Enrollment (Actual)

533

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Bursa, Turkey (Türkiye)
        • Bursa Yüksek İhtisas Training and Research Hospital, Bursa, Türkiye

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discriminatory Performance of the BBCMADE Nomogram
Time Frame: At time of procedure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fusun Gozen

Investigators

  • Principal Investigator: Füsun Gözen, SBÜ Bursa Yüksek İhtisas Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2025

Primary Completion (Actual)

February 20, 2026

Study Completion (Actual)

March 31, 2026

Study Registration Dates

First Submitted

June 5, 2026

First Submitted That Met QC Criteria

June 5, 2026

First Posted (Actual)

June 10, 2026

Study Record Updates

Last Update Posted (Actual)

June 10, 2026

Last Update Submitted That Met QC Criteria

June 5, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-TBEK 2025/10-09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared. This is a single-center observational study conducted at a public hospital. Data sharing is not planned due to institutional privacy regulations and the absence of external funding requiring data sharing.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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