Acute Pulmonary Insufficiency Following Thoracic SurgeryNCT02583984
Metabolomic Study in Exhaled Breath Condensate of Thoracic Surgical Patients
An observational study of Acute Pulmonary Insufficiency Following Thoracic Surgery and Ventilator-associated Lung Injury, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Acute Pulmonary Insufficiency Following Thoracic Surgery, Ventilator-associated Lung Injury
- What is being tested?
- Thoracic Surgery with Lung Resection and Thoracic Surgery without Lung Resection
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2017to Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Thoracic surgical patients requiring lung isolation
Who may be able to join
- Thoracic surgical patients requiring lung isolation
- Pulmonary resection: lobectomy, segmentectomy
- Esophageal surgery and no pulmonary resection
- Mediastinal surgery and no pulmonary resection
Who cannot join
- Metabolic disorder
- Metabolic syndrome
- Diabetes
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Anesthesiology, National Taiwan University Hospital
Taipei, 100
About this study
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.
- Conditions
- Acute Pulmonary Insufficiency Following Thoracic Surgery, Ventilator-associated Lung Injury
- Being tested
- Thoracic Surgery with Lung Resection, Thoracic Surgery without Lung Resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic Surgery with Lung ResectionProcedure or surgery
General anesthesia and lung separation Thoracic surgery with lung resection, such as lobectomy, segmentectomy
Thoracic Surgery without Lung ResectionProcedure or surgery
General anesthesia and lung separation Thoracic surgery without lung resection, such as esophageal surgery, mediastinal surgery
| Study group | Role | What they receive |
|---|---|---|
| Thoracic Surgery with Lung Resection | General anesthesia and lung separation Thoracic Surgery with Lung Resection, such as lobectomy, segmentectomy Receives: 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 Receives: Procedure: Thoracic Surgery without Lung Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with acute lung injury following thoracic surgery
Measured: 30 days
Secondary outcomes (1)
Metabolome of exhaled breath condensate associated with lung injury in thoracic surgery
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startMar 2017
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Pulmonary Insufficiency Following Thoracic SurgeryStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ya-Jung Cheng, MD, PhD, Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583984
- Sponsor's protocol ID
- 201505133RINC
- Status last verified
- May 2016
- First submitted
- 14 Oct 2015
- Last updated
- 25 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomic Study in Exhaled Breath Condensate of Thoracic Surgical Patients
- ClinicalTrials.gov ID
- NCT02583984
- Acronym / sponsor ID
- 201505133RINC
- Conditions
- Acute Pulmonary Insufficiency Following Thoracic Surgery, Ventilator-associated Lung Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Mar 2017
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 22 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracic Surgery with Lung Resection | – | Procedure: Thoracic Surgery with Lung ResectionGeneral anesthesia and lung separation Thoracic Surgery with Lung Resection, such as lobectomy, segmentectomy |
| Thoracic Surgery without Lung Resection | – | Procedure: Thoracic Surgery without Lung ResectionGeneral anesthesia and lung separation Thoracic Surgery without Lung Resection, such as esophageal surgery, mediastinal surgery |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Thoracic surgical patients requiring lung isolation
Key inclusion criteria (4 listed)
- Thoracic surgical patients requiring lung isolation
- Pulmonary resection: lobectomy, segmentectomy
- Esophageal surgery and no pulmonary resection
- Mediastinal surgery and no pulmonary resection
Key exclusion criteria (4 listed)
- Metabolic disorder
- Metabolic syndrome
- Diabetes
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracic Surgery with Lung ResectionGeneral anesthesia and lung separation Thoracic surgery with lung resection, such as lobectomy, segmentectomy | Procedure or surgery | Thoracic Surgery with Lung Resection |
| Thoracic Surgery without Lung ResectionGeneral anesthesia and lung separation Thoracic surgery without lung resection, such as esophageal surgery, mediastinal surgery | Procedure or surgery | Thoracic Surgery without Lung Resection |
Primary outcome
Number of participants with acute lung injury following thoracic surgery
Time frame: 30 days
1 secondary outcome
Metabolome of exhaled breath condensate associated with lung injury in thoracic surgery
Time frame: 5 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ya-Jung Cheng, MD, PhD study chair
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pulmonary Insufficiency Following Thoracic Surgery and Ventilator-associated Lung Injury, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ya-Jung Cheng, MD, PhD (+886-2-23123456 ext. 65517, chengyj@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with acute lung injury following thoracic surgery (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2016.