← Back to all trials
Completed
NCT07638917
BBCMADE Nomogram Validation for High-Risk Gastric Content in Sedative Endoscopy
Conditions: Gastric Content Aspiration Risk, Gastrointestinal Endoscopy, Anesthesia Complications
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 533
Sponsor: Fusun Gozen
Location: Bursa Yüksek İhtisas Training and Research Hospital, Bursa, Türkiye Bursa
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 \
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07638917). StuddyBuddy aggregates publicly available trial information.