Volatile Organic Compounds (VOCs) of Exhaled Breath in Patients With GI Bleeding

• Conditions: Volatile Organic Compounds; Gastrointestinal Hemorrhage
• Interventions: Diagnostic Test: Collection of exhaled breath

• Registration Number: NCT04226079
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Cross sectional case-control study investigating the difference of volatile organic compound in the exhaled breath of the patients with GI bleeding and normal population.

Detailed Description

This study investigates the difference of volatile organic compound in the exhaled breath of the patients with GI bleeding and normal population. We aimed to find out the biomarkers for GI bleeding.

Study Timeline

• Status Verified: 2020-01
• Study Start: 2020-01
• Study First Submitted: 2020-01-08
• Study First Submitted QC: 2020-01-10
• Last Update Submitted: 2020-01-10
• Study First Posted: 2020-01-13
• Last Update Posted: 2020-01-13
• Primary Completion: 2020-04
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Adults aged between 20 and 80
• Low possibility of gastrointestinal bleeding was proven by esophagogastroduodenoscopy and colonoscopy which were performed within 1 year.
• NSAID non-user (within 1 months before the date of inclusion)

Exclusion Criteria

• Diagnosis of malignancy diagnosed within 5 years
• Past medical history of chronic liver disease, chronic kidney disease, chronic lung disease, chronic bronchial disease, asthma
• Surgical history of any kind of gastrectomy
• Surgical history of any kind of lung resection which could impact the patient's lung function.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal control	Collection of exhaled breath	Normal population with low prevalence of gastrointestinal bleeding who underwent EGD and CFS which revealed no abnormal finding.
Patients with GI bleeding	Collection of exhaled breath	Patients who visited emergency room and were highly suspected to have recent or active upper GI bleeding and scheduled for upper GI endoscopy.

Primary Outcome Measures

Name	Time	Method
VOC Patterns	1 day of 1st emergency room (ER) visit for GI bleeding	Patterns of volatile organic compounds recognized by sensor array

Secondary Outcome Measures

Name	Time	Method
Measurement of VOC	1 day of 1st emergency room (ER) visit for GI bleeding	Qualitative and quantitative assay of volatile organic compounds by GC-MS
Change of VOC patterns	2nd visit (about 2weeks apart from 1st visit)	Change of the patterns of volatile organic compounds recognized by sensor array after recovery from GI bleeding

Trial Locations

Locations (1)

Jin Ju Choi; 🇰🇷 Seoul, Gyunggi-do, Korea, Republic of