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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-20

Study Completion Date

2025-07-20

Brief Summary

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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.

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Detailed Description

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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

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Volatile Organic Compound Gastrointestinal Hemorrhage

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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No bleeding

No blood in the upper gastrointestinal tract

Gastroscopy

Intervention Type DEVICE

Gastroscopy for all included patients

Gas Chromatography - Mass Spectrometry

Intervention Type DIAGNOSTIC_TEST

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

Minor bleeding

A little blood in the upper gastrointestinal tract

Gastroscopy

Intervention Type DEVICE

Gastroscopy for all included patients

Gas Chromatography - Mass Spectrometry

Intervention Type DIAGNOSTIC_TEST

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

Major bleeding

Plenty of blood in the upper gastrointestinal tract

Gastroscopy

Intervention Type DEVICE

Gastroscopy for all included patients

Gas Chromatography - Mass Spectrometry

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Gastroscopy

Gastroscopy for all included patients

Intervention Type DEVICE

Gas Chromatography - Mass Spectrometry

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No