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NCT Number: NCT06877507

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

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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Key information

Conditions

Volatile Organic Compound Digestive System Diseases Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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:

  • Identify characteristic VOC profiles in exhaled breath of AUGIB patients.
  • Develop a VOC-based predictive model with sensitivity and specificity ≥0.7.
  • Establish rapid diagnostic criteria to enhance clinical decision-making.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Sensitivity and specificity of the diagnostic model

    Time frame: 4 months

    targets ≥0.7

Secondary outcomes

  1. Identification of key VOCs

    Time frame: 4 months

    e.g., aldehydes, ketones

  2. Differences in VOC concentrations across 3 bleeding severity groups

    Time frame: 4 months

    Different VOCs

Sponsors and collaborators

Lead sponsor

Beijing 302 Hospital

Other

Registry information

Official study title

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

Acronym: VOCsAUGIB

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 14, 2025
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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