Analysis the Vocs in Upper GI Bleeding Patients

• Conditions: Upper GI Bleeding

• Registration Number: NCT05457062
• Lead Sponsor: Affiliated Hospital to Academy of Military Medical Sciences

Brief Summary

This project aims to collect the exhaled breath of patients with acute upper gastrointestinal bleeding clinically, divide them into large, small and no bleeding groups according to the results of gastroscopy, analyze the characteristics of volatile organic compound components in exhaled breath, construct a discriminant model, and then analyze the sensitivity and specificity, and the target sensitivity and specificity reach more than 0.7, and formulate diagnostic criteria.

Detailed Description

Upper gastrointestinal bleeding is one of the most common gastrointestinal emergencies and has a high mortality rate. Its clinical manifestations are hematemesis and melena, gastroscopy is the gold standard for diagnosing upper gastrointestinal bleeding, but due to its expensive equipment, long training cycle of personnel, gastroscopy itself is an invasive operation, poor patient tolerance, high risk of examination, often lead to the diagnosis of upper gastrointestinal bleeding is not timely, missing the best treatment time. Volatile organic compound analysis in exhalation is based on the patient's metabolic component analysis technology, a new means of disease diagnosis, due to its advantages of convenient collection, non-invasive, rapid detection, etc., it has been applied in the diagnosis of various diseases such as drunken screening and Helicobacter pylori infection, but has not been studied in the diagnosis of upper gastrointestinal bleeding. This project aims to collect the exhaled breath of patients with acute upper gastrointestinal bleeding clinically, divide them into large, small and no bleeding groups according to the results of gastroscopy, analyze the characteristics of volatile organic compound components in exhaled breath, construct a discriminant model, and then analyze the sensitivity and specificity, and the target sensitivity and specificity reach more than 0.7, and formulate diagnostic criteria. This study will improve the timeliness of upper GI bleeding detection, which is of great significance for effectively reducing the mortality rate of upper GI bleeding.

Study Timeline

• Status Verified: 2022-06
• Study Start: 2022-07-04
• Study First Submitted: 2022-07-09
• Study First Submitted QC: 2022-07-09
• Last Update Submitted: 2022-07-09
• Study First Posted: 2022-07-13
• Last Update Posted: 2022-07-13
• Primary Completion: 2022-12
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

upper GI bleeding patients -

Exclusion Criteria

Severe cardiopulmonary disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
death in hospital	6 weeks	all cause death in hospital

Secondary Outcome Measures

Name	Time	Method
rebleeding	5 days	rebleeding in five days

Trial Locations

Locations (1)

the Fifth Medical Center of Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China