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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06877507

Acronym

VOCsAUGIB

Enrollment

200

Registered

2025-03-14

Start date

2025-03-20

Completion date

2025-07-20

Last updated

2025-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Hemorrhage, Volatile Organic Compound

Keywords

Volatile Organic Compound, Acute Upper Gastrointestinal Bleeding, Exhaled Breath

Brief 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.

Interventions

DEVICEGastroscopy

Gastroscopy for all included patients

DIAGNOSTIC_TESTGas Chromatography - Mass Spectrometry

Using a patient's exhaled breath test with Gas Chromatography - Mass Spectrometry

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age ≥18 years; 2. Clinical suspicion of AUGIB (e.g., hematemesis, melena); 3. Fasting ≥4 hours; 4. Signed informed consent.

Exclusion criteria

1. Severe pulmonary dysfunction or recent lung infection (within 1 week); 2. Cardiac/renal failure or disseminated intravascular coagulation; 3. Contraindications to endoscopy; 4. High-risk conditions (e.g., massive ascites); 5. Alcohol consumption within 24 hours; 6. Pregnancy.

Design outcomes

Primary

Measure	Time frame	Description
Sensitivity and specificity of the diagnostic model	4 months	targets ≥0.7

Secondary

Measure	Time frame	Description
Identification of key VOCs	4 months	e.g., aldehydes, ketones
Differences in VOC concentrations across 3 bleeding severity groups	4 months	Different VOCs

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026