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 Locations

  • Taiwan
      • 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
Procedure: Thoracic Surgery with Lung Resection
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
Procedure: Thoracic Surgery without Lung Resection
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.

Sponsor

National Taiwan University Hospital

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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