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

ConditionsVolatile Organic CompoundGastrointestinal Hemorrhage
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBeijing 302 Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years;

Clinical suspicion of AUGIB (e.g., hematemesis, melena);

Fasting ≥4 hours;

Signed informed consent.

Disqualifiers

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);

Trial population

Patients requiring endoscopy for suspected AUGIB

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Gastroscopy

    Device

    Gastroscopy for all included patients

  • Gas Chromatography - Mass Spectrometry

    Diagnostic test

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

Treatment groups

200 Participants
are divided into 3 treatment groups
Group A: No bleeding2 interventions
Group B: Minor bleeding2 interventions
Group C: Major bleeding2 interventions

Trial outcomes

Primary outcomes

1

Sensitivity and specificity of the diagnostic model

targets ≥0.7

Time frame
4 months

Secondary outcomes

1

Identification of key VOCs

e.g., aldehydes, ketones

Time frame
4 months
2

Differences in VOC concentrations across 3 bleeding severity groups

Different VOCs

Time frame
4 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing 302 Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: