Thoracic Surgery With One-lung VentilationNCT00515905
One-lung Ventilation: Expression of Pulmonary Inflammatory Mediators
A study testing Sevoflurane/propofol in people with Thoracic Surgery With One-lung Ventilation, run by University of Zurich at 1 site in Switzerland.
Trial summary
One-lung ventilation; organ protection; volatile anesthetics One-lung ventilation has become a common procedure for thoracoscopic surgery. Two hypothesis will be tested in this study: 1. Are inflammatory mediators increased in the re-ventilated lung after short-period pulmonary collapse? 2. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thoracic Surgery With One-lung Ventilation
- What is being tested?
- Sevoflurane/propofol
- How many people
- 76 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2004to Sep 2007
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Thoracic surgery (thoracotomy, thoracoscopy) with one-lung ventilation
Who cannot join
- Immunosuppressive therapy
- Ongoing inflammatory processes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lung: One-lung Ventilation: Expression of Pulmonary Inflammatory Mediators After Deflation and Re-expansion of the Lung During Thoracic Surgery
One-lung ventilation; organ protection; volatile anesthetics
One-lung ventilation has become a common procedure for thoracoscopic surgery. Two hypothesis will be tested in this study:
- Are inflammatory mediators increased in the re-ventilated lung after short-period pulmonary collapse?
- Does Sevoflurane influence the production of inflammatory mediators in the re-inflated lung? Therefore, this study will elucidate the potential protective effect of a volatile anaesthetic (sevoflurane) on the production of inflammatory mediators by the respiratory compartment of the lung, i.e. the alveolar epithelium.
- Trial with immunomodulatory product / biological
- Being tested
- Sevoflurane/propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sevoflurane/propofolDrug
Sevoflurane/propofol
What is being measured
The primary outcome is the main question the study is designed to answer.
One-lung ventilation measurement in the re-ventilated lung after short-period pulmonary collapse
Measured: Sep 07
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2007 (estimated)
- Study startOct 2004
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Surgery With One-lung VentilationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Investigators
- 01 Studienregister MasterAdmins, Study director, UniversitaetsSpital Zuerich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00515905
- Sponsor's protocol ID
- StV 20-2004
- Status last verified
- Mar 2008
- First submitted
- 13 Aug 2007
- Last updated
- 15 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung: One-lung Ventilation: Expression of Pulmonary Inflammatory Mediators After Deflation and Re-expansion of the Lung During Thoracic Surgery
- ClinicalTrials.gov ID
- NCT00515905
- Acronym / sponsor ID
- StV 20-2004
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Oct 2004
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 14 Aug 2007 (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.
One-lung ventilation; organ protection; volatile anesthetics
One-lung ventilation has become a common procedure for thoracoscopic surgery. Two hypothesis will be tested in this study:
- Are inflammatory mediators increased in the re-ventilated lung after short-period pulmonary collapse?
- Does Sevoflurane influence the production of inflammatory mediators in the re-inflated lung? Therefore, this study will elucidate the potential protective effect of a volatile anaesthetic (sevoflurane) on the production of inflammatory mediators by the respiratory compartment of the lung, i.e. the alveolar epithelium.
- Trial with immunomodulatory product / biological
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Thoracic surgery (thoracotomy, thoracoscopy) with one-lung ventilation
Key exclusion criteria (2 listed)
- Immunosuppressive therapy
- Ongoing inflammatory processes
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 |
|---|---|---|
| Sevoflurane/propofolSevoflurane/propofol | Drug | – |
Primary outcome
One-lung ventilation measurement in the re-ventilated lung after short-period pulmonary collapse
Time frame: Sep 07
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2010.
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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.
01 Studienregister MasterAdmins study director
UniversitaetsSpital Zuerich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane/propofol in people with Thoracic Surgery With One-lung Ventilation, run by University of Zurich at 1 site in Switzerland.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 15 Sep 2010. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One-lung ventilation measurement in the re-ventilated lung after short-period pulmonary collapse (time frame: Sep 07). 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 15 Sep 2010.