Rapid Diagnostic Technology for AUGIB Based on Analysis of VOCs in Exhaled Breath
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Gastroscopy, Gas Chromatography - Mass Spectrometry.
- Who it may be relevant to
- Registry conditions: Volatile Organic Compound, Gastrointestinal Hemorrhage. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Rapid Diagnostic Technology for Acute Upper Gastrointestinal Bleeding Based on Analysis of Volatile Organic Compounds (VOCs) in Exhaled Breath
Overview
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.
Interventions
- 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
Primary outcome measures
- Sensitivity and specificity of the diagnostic model [Time frame: 4 months]
Secondary outcome measures (2)
- Identification of key VOCs [Time frame: 4 months]
- Differences in VOC concentrations across 3 bleeding severity groups [Time frame: 4 months]
Eligibility criteria
Inclusion criteria
- Age ≥18 years;
- Clinical suspicion of AUGIB (e.g., hematemesis, melena);
- Fasting ≥4 hours;
- Signed informed consent.
Exclusion criteria
- Severe pulmonary dysfunction or recent lung infection (within 1 week);
- Cardiac/renal failure or disseminated intravascular coagulation;
- Contraindications to endoscopy;
- High-risk conditions (e.g., massive ascites);
- Alcohol consumption within 24 hours;
- Pregnancy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06877507 · 302-2025-VOCs · 82270694