- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02583984
Metabolomic Study in Exhaled Breath Condensate of Thoracic Surgical Patients
May 24, 2016 updated by: National Taiwan University Hospital
Acute lung injury (ALI) following thoracic surgery remains a major source of morbidity and mortality after lung resection.
One-lung ventilation (OLV) is usually required in thoracic surgery.
OLV is also an important predictor of postoperative ALI.
Recent laboratory findings suggested that tissue hypoxemia and ischemia / reperfusion injury of the collapsed lungs during OLV is the major cause of lung injury.
Exhaled Breath Condensate (EBC), which is the exhalate from breath typically collected by cooling device, contains most molecules found in the airway.
Metabolomics refers to systematic and scientific study of chemical processes involving metabolites.
This study will collect EBC for metabolomic analysis and aim to elucidate the biochemical reactions during one-lung ventilation and pathological mechanisms of acute lung injury following thoracic surgery.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Acute lung injury (ALI) following thoracic surgery remains a major source of morbidity and mortality after lung resection.
Despite the advancement in both the surgical techniques and the perioperative management, the incidence of postoperative ALI remains remarkable.
Risk factors for postoperative lung injury are evident, including preoperative pulmonary function, type of surgical procedure, intraoperative fluid management, one-lung ventilation, and ventilator settings.
One-lung ventilation (OLV) is usually required in thoracic surgery.
OLV is also an important predictor of postoperative ALI.
Recent laboratory findings suggested that tissue hypoxemia and ischemia / reperfusion injury of the collapsed lungs during OLV is the major cause of lung injury.
Exhaled Breath Condensate (EBC), which is the exhalate from breath typically collected by cooling device, contains most molecules found in the airway.
EBC analysis has potential applications in lung disease, such as severity of airway inflammation in asthmatic patients.
Collecting EBC is simple and non-invasive, in contrast to bronchoscopy for lung biopsy or bronchoalveolar lavage.
Metabolomics refers to systematic and scientific study of chemical processes involving metabolites.
This study will collect EBC from thoracic surgical patients before, during, and after OLV.
The investigators will perform metabolomic analysis and aim to elucidate the biochemical reactions during one-lung ventilation and pathological mechanisms of acute lung injury following thoracic surgery.
Study Type
Observational
Enrollment (Anticipated)
40
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: Ya-Jung Cheng, MD, PhD
- Phone Number: 65517 +886-2-23123456
- Email: chengyj@ntu.edu.tw
Study Locations
-
-
-
Taipei City, Taiwan, 100
- Department of Anesthesiology, National Taiwan University Hospital
-
-
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
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Thoracic surgical patients requiring lung isolation
Description
Inclusion Criteria:
- Thoracic surgical patients requiring lung isolation
- Pulmonary resection: lobectomy, segmentectomy
- Esophageal surgery and no pulmonary resection
- Mediastinal surgery and no pulmonary resection
Exclusion Criteria:
- Metabolic disorder
- Metabolic syndrome
- Diabetes
- 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 |
---|---|
Thoracic Surgery with Lung Resection
General anesthesia and lung separation Thoracic Surgery with Lung Resection, such as lobectomy, segmentectomy
|
General anesthesia and lung separation Thoracic surgery with lung resection, such as lobectomy, segmentectomy
|
Thoracic Surgery without Lung Resection
General anesthesia and lung separation Thoracic Surgery without Lung Resection, such as esophageal surgery, mediastinal surgery
|
General anesthesia and lung separation Thoracic surgery without lung resection, such as esophageal surgery, mediastinal surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with acute lung injury following thoracic surgery
Time Frame: 30 days
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Metabolome of exhaled breath condensate associated with lung injury in thoracic surgery
Time Frame: 5 hours
|
5 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Ya-Jung Cheng, MD, PhD, National Taiwan University 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
March 1, 2017
Primary Completion (Anticipated)
March 1, 2018
Study Completion (Anticipated)
March 1, 2018
Study Registration Dates
First Submitted
October 14, 2015
First Submitted That Met QC Criteria
October 21, 2015
First Posted (Estimate)
October 22, 2015
Study Record Updates
Last Update Posted (Estimate)
May 25, 2016
Last Update Submitted That Met QC Criteria
May 24, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201505133RINC
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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