Metabolomic Study in Exhaled Breath Condensate of Thoracic Surgical Patients

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: Ventilator-associated Lung Injury; Acute Pulmonary Insufficiency Following Thoracic Surgery
• Intervention / Treatment: Procedure: Thoracic Surgery with Lung Resection; Procedure: Thoracic Surgery without Lung Resection

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

Study Locations

• Taiwan
  • Taipei City, Taiwan, 100
    • Department of Anesthesiology, National Taiwan University Hospital

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

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	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Metabolome of exhaled breath condensate associated with lung injury in thoracic surgery	5 hours

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Study Chair: Ya-Jung Cheng, MD, PhD, National Taiwan University Hospital

Study record dates

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: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Wounds and Injuries; Thoracic Injuries; Respiratory Insufficiency; Lung Injury
• Other Study ID Numbers: 201505133RINC