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Status unknownNCT02583984Updated May 25, 2016

Metabolomic Study in Exhaled Breath Condensate of Thoracic Surgical Patients

An observational study in Acute Pulmonary Insufficiency Following Thoracic Surgery and Ventilator-associated Lung Injury, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-05-25.

Sponsored by National Taiwan University Hospital · Observational

The sponsor has not verified this record recently (last verified May 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
20 Years to 80 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

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

Lung Injury

399 studies on the registry are indexed under Lung Injury; 50 are open to participants now.

This study's planned enrollment of 40 is below the median of 70 across 136 observational studies indexed under Lung Injury.

Browse Lung Injury studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Thoracic surgical patients requiring lung isolation

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

Exclusion Criteria:

  • Metabolic disorder
  • Metabolic syndrome
  • Diabetes
  • Pregnancy
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • ProcedureThoracic Surgery with Lung Resection

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

  • ProcedureThoracic Surgery without Lung Resection

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

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What researchers measure

Primary outcomes

  1. Number of participants with acute lung injury following thoracic surgery

    Time frame: 30 days

Secondary outcomes

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

    Time frame: 5 hours

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Study locations

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

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02583984
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Oct 22, 2015
Start date
Mar 2017
Primary completion
Mar 2018 (estimated)
Completion
Mar 2018 (estimated)
Last update
May 25, 2016

Study contacts

Ya-Jung Cheng, MD, PhD
Contact
chengyj@ntu.edu.tw
+886-2-23123456 ext. 65517
Ya-Jung Cheng, MD, PhD
study chair · National Taiwan University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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