Metabolomic Study in Exhaled Breath Condensate of Thoracic Surgical Patients

NCT02583984 | Unknown DMC

• 1 other identifier: 201505133RINC
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Number of participants with acute lung injury following thoracic surgery

  30 days

Secondary Outcomes (1)

• Metabolome of exhaled breath condensate associated with lung injury in thoracic surgery

  5 hours

Study Arms (2)

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

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

Interventions

Thoracic Surgery with Lung Resection PROCEDURE

General anesthesia and lung separation Thoracic surgery with lung resection, such as lobectomy, segmentectomy

Thoracic Surgery with Lung Resection

Thoracic Surgery without Lung Resection PROCEDURE

General anesthesia and lung separation Thoracic surgery without lung resection, such as esophageal surgery, mediastinal surgery

Thoracic Surgery without Lung Resection

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Thoracic surgical patients requiring lung isolation

You may qualify if:

• Thoracic surgical patients requiring lung isolation
• Pulmonary resection: lobectomy, segmentectomy
• Esophageal surgery and no pulmonary resection
• Mediastinal surgery and no pulmonary resection

You may not qualify if:

• Metabolic disorder
• Metabolic syndrome
• Diabetes
• Pregnancy

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Department of Anesthesiology, National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Exhaled breath condensate

MeSH Terms

Interventions

Thoracic Surgical Procedures

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Ya-Jung Cheng, MD, PhD

  National Taiwan University Hospital

  STUDY CHAIR

Central Study Contacts

Ya-Jung Cheng, MD, PhD

CONTACT

+886-2-23123456; chengyj@ntu.edu.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2015
• First Posted: October 22, 2015
• Study Start: March 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: May 25, 2016

Record last verified: 2016-05

Locations

TW (1)