跳至主要内容
临床试验/NCT05457062
NCT05457062Unknown不适用

Study Based on Volatile Organic Compounds Analysis in Patients With Acute Upper Gastrointestinal Bleeding

Affiliated Hospital to Academy of Military Medical Sciences1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2022年7月4日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
500
试验地点
1
主要终点
death in hospital

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • upper GI bleeding patients -

排除标准

  • Severe cardiopulmonary disease

结局指标

主要结局

death in hospital

时间窗: 6 weeks

all cause death in hospital

次要结局

  • rebleeding(5 days)

研究者

发起方
Affiliated Hospital to Academy of Military Medical Sciences
申办方类型
Other
责任方
Sponsor

研究点 (1)

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