NCT00515905

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:

  1. 1.Are inflammatory mediators increased in the re-ventilated lung after short-period pulmonary collapse?
  2. 2.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.
  3. 3.Trial with immunomodulatory product / biological

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2007

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

September 15, 2010

Status Verified

March 1, 2008

Enrollment Period

2.9 years

First QC Date

August 13, 2007

Last Update Submit

September 14, 2010

Conditions

Thoracic Surgery With One-lung Ventilation

Outcome Measures

Primary Outcomes (1)

  • One-lung ventilation measurement in the re-ventilated lung after short-period pulmonary collapse

    Sep 07

Interventions

Sevoflurane/propofolDRUG

Sevoflurane/propofol

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Immunosuppressive therapy
  • Ongoing inflammatory processes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Zurich

Zurich, Switzerland

Location

MeSH Terms

Interventions

SevofluranePropofol

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • 01 Studienregister MasterAdmins

    UniversitaetsSpital Zuerich

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 13, 2007

First Posted

August 14, 2007

Study Start

October 1, 2004

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

September 15, 2010

Record last verified: 2008-03

Locations

CH(1)