NCT06877507

Rapid Diagnostic Technology for AUGIB Based on Analysis of VOCs in Exhaled Breath

Rapid Diagnostic Technology for Acute Upper Gastrointestinal Bleeding Based on Analysis of Volatile Organic Compounds (VOCs) in Exhaled Breath

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Beijing 302 Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to develop a non-invasive and rapid diagnostic technology for acute upper gastrointestinal bleeding (AUGIB) by analyzing volatile organic compounds (VOCs) in exhaled breath. Clinically confirmed patients will be divided into three groups (no bleeding, minor bleeding, major bleeding) based on endoscopic findings. VOC profiles will be analyzed to construct a predictive model, validated for sensitivity and specificity (both targets ≥0.7). This approach addresses the limitations of endoscopy in emergency or resource-limited settings, improving diagnostic efficiency and reducing mortality.

Detailed description

Acute upper gastrointestinal bleeding (AUGIB) is a common emergency with an annual incidence of 100-180/100,000 and mortality of 2%-15%. Endoscopy, the gold standard, is invasive and equipment-dependent, limiting its use in primary care or emergencies. Exhaled breath VOCs analysis, a non-invasive and portable method, has been applied in other diseases but not yet explored for AUGIB. Objectives: 1. Identify characteristic VOC profiles in exhaled breath of AUGIB patients. 2. Develop a VOC-based predictive model with sensitivity and specificity ≥0.7. 3. Establish rapid diagnostic criteria to enhance clinical decision-making.

Conditions

• Volatile Organic Compound
• Gastrointestinal Hemorrhage

Interventions

Type	Name	Description
DEVICE	Gastroscopy	Gastroscopy for all included patients
DIAGNOSTIC_TEST	Gas Chromatography - Mass Spectrometry	Using a patient's exhaled breath test with Gas Chromatography - Mass Spectrometry

Timeline

• Start date: 2025-03-20
• Primary completion: 2025-07-20
• Completion: 2025-07-20
• First posted: 2025-03-14
• Last updated: 2025-03-14