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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive adult patients presenting for elective sedative gastrointestinal endoscopy at Bursa Yuksek Ihtisas Training and Research Hospital
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| Name | Affiliation | Role |
|---|---|---|
| Füsun Gözen | SBÜ Bursa Yüksek İhtisas Training and Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bursa Yüksek İhtisas Training and Research Hospital, Bursa, Türkiye | Bursa | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38159677 | Background | 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. | |
| 26603797 |
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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.
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| ID | Term |
|---|---|
| D006863 | Hydrogen-Ion Concentration |
| ID | Term |
|---|---|
| D055598 | Chemical Phenomena |
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| 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. |
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| 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. |
| 25267952 | 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. |
| 28045707 | 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. |