Anesthesia Complications, Gastric Content Aspiration Risk, Gastrointestinal Endoscopy
Conditions
Keywords
gastric volume, nomogram, BBCMADE, aspiration risk, sedation, residual gastric content, preoperative assessment
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.
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).
Interventions
DIAGNOSTIC_TESTBBCMADE 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_TESTEndoscopic 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
Fusun Gozen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Discriminatory Performance of the BBCMADE Nomogram | 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. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORFüsun Gözen
SBÜ Bursa Yüksek İhtisas Training and Research Hospital
Outcome results
None listed