- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05457062
Analysis the Vocs in Upper GI Bleeding Patients
July 9, 2022 updated by: Affiliated Hospital to Academy of Military Medical Sciences
Study Based on Volatile Organic Compounds Analysis in Patients With Acute 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.
Study Overview
Status
Recruiting
Conditions
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 Type
Observational
Enrollment (Anticipated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Qian Bi, phD
- Phone Number: 66933216
- Email: 381021791@qq.com
Study Locations
-
-
Beijing
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Beijing, Beijing, China, 100071
- Recruiting
- The fifth Medical Center of Chinese PLA General Hospital
-
Contact:
- Yan Liu, Ph.D.
- Phone Number: 010-66947473
- Email: 13911798288@163.com
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
upper GI bleeding patients who will under go endoscopy examination
Description
Inclusion Criteria: upper GI bleeding patients -
Exclusion Criteria: Severe cardiopulmonary disease
-
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 |
---|
large amount of bleeding
large amount of upper GI bleeding after EGD identified
|
no bleeding
no upper GI bleeding after EGD identified
|
small amount of bleeding
small amount of upper GI bleeding after EGD identified
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
death in hospital
Time Frame: 6 weeks
|
all cause death in hospital
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
rebleeding
Time Frame: 5 days
|
rebleeding in five days
|
5 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Actual)
July 4, 2022
Primary Completion (Anticipated)
December 1, 2022
Study Completion (Anticipated)
June 1, 2023
Study Registration Dates
First Submitted
July 9, 2022
First Submitted That Met QC Criteria
July 9, 2022
First Posted (Actual)
July 13, 2022
Study Record Updates
Last Update Posted (Actual)
July 13, 2022
Last Update Submitted That Met QC Criteria
July 9, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- vocs in upper GI bleeding
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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