BBCMADE Nomogram Validation for High-Risk Gastric Content in Sedative Endoscopy (BBCMADE)
5. juni 2026 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret beskrivelse
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).
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
533
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Bursa, Tyrkiet (Türkiye)
- Bursa Yüksek İhtisas Training and Research Hospital, Bursa, Türkiye
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Consecutive adult patients presenting for elective sedative gastrointestinal endoscopy at Bursa Yuksek Ihtisas Training and Research Hospital
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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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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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.
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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Discriminatory Performance of the BBCMADE Nomogram
Tidsramme: At time of procedure
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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.
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At time of procedure
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Füsun Gözen, SBÜ Bursa Yüksek İhtisas Training and Research Hospital
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
20. november 2025
Primær færdiggørelse (Faktiske)
20. februar 2026
Studieafslutning (Faktiske)
31. marts 2026
Datoer for studieregistrering
Først indsendt
5. juni 2026
Først indsendt, der opfyldte QC-kriterier
5. juni 2026
Først opslået (Faktiske)
10. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2024-TBEK 2025/10-09
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
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.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Studerer et amerikansk FDA-reguleret enhedsprodukt
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