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

March 10, 2025 updated by: Beijing 302 Hospital

Rapid Diagnostic Technology for Acute Upper Gastrointestinal Bleeding Based on Analysis of Volatile Organic Compounds (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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients requiring endoscopy for suspected AUGIB

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
No bleeding
No blood in the upper gastrointestinal tract
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
Minor bleeding
A little blood in the upper gastrointestinal tract
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
Major bleeding
Plenty of blood in the upper gastrointestinal tract
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity of the diagnostic model
Time Frame: 4 months
targets ≥0.7
4 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing 302 Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 20, 2025

Primary Completion (Estimated)

July 20, 2025

Study Completion (Estimated)

July 20, 2025

Study Registration Dates

First Submitted

March 10, 2025

First Submitted That Met QC Criteria

March 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 10, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 302-2025-VOCs
  • 82270694 (Other Grant/Funding Number: National Natural Science Foundation of China)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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