One-lung Ventilation: Expression of Pulmonary Inflammator... | NCT00515905

Studies
One-lung Ventilation: Expression of Pulmonary Inflammatory Mediators

NCT00515905

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Sep 15, 2010Estimated

Enrollment

76Estimated

Phase

Not Applicable

Conditions

Thoracic Surgery With One-lung Ventilation

Interventions

Sevoflurane/propofol

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2004

Primary Completion Date

Sep 2007Actual

Completion Date

Sep 2007Actual

First Submitted Date

Aug 13, 2007

First Submission Date that Met QC Criteria

Aug 13, 2007

First Posted Date

Aug 14, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 14, 2010

Last Update Posted Date

Sep 15, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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:

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

76Estimated

Name	Type	Description	Arm Group Labels	Other Names
Sevoflurane/propofol	Drug	Sevoflurane/propofol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
One-lung ventilation measurement in the re-ventilated lung after short-period pulmonary collapse		Sep 07

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Thoracic surgery (thoracotomy, thoracoscopy) with one-lung ventilation

Exclusion criteria:

Immunosuppressive therapy
Ongoing inflammatory processes

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
01 Studienregister MasterAdmins	UniversitaetsSpital Zuerich	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Zurich		Zurich			Switzerland

Intervention Browse Module

MeSH Terms

ID	Term
D000077149	Sevoflurane
D015742	Propofol

Ancestor Terms

ID	Term
D008738	Methyl Ethers
D004987	Ethers
D009930	Organic Chemicals
D006845	Hydrocarbons, Fluorinated

Browse Leaves

Not provided

Browse Branches

Not provided