Metabolomic Study in Exhaled Breath Condensate of Thoracic Surgical Patients

Ventilator-associated Lung Injury Clinical Trial

Official title:

Metabolomic Study in Exhaled Breath Condensate of Thoracic Surgical Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02583984
• Other study ID #: 201505133RINC
• Status: Not yet recruiting
• Phase: N/A
• First received: October 14, 2015
• Last updated: May 24, 2016
• Start date: March 2017
• Est. completion date: March 2018

Study information

• Verified date: May 2016
• Source: National Taiwan University Hospital
• Contact: Ya-Jung Cheng, MD, PhD
• Phone: +886-2-23123456
• Email: chengyj[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Pulmonary Insufficiency Following Thoracic Surgery
• Lung Injury
• Ventilator-associated Lung Injury

Intervention

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

Locations

Country	Name	City	State
Taiwan	Department of Anesthesiology, National Taiwan University Hospital	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with acute lung injury following thoracic surgery		30 days	No
Secondary	Metabolome of exhaled breath condensate associated with lung injury in thoracic surgery		5 hours	No