Infection Clinical Trial
— TDPAFDOfficial title:
Fixation of Thoracic Epidural Catheters Influencing Catheter-related Infections and Dislocation
Verified date | December 2011 |
Source | Heinrich-Heine University, Duesseldorf |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Observational |
Major interest in our investigation is to find out whether distinct fixation techniques influence catheter dislocation and/ or incidence of local inflammation. A systematic comparison of two different fixation techniques with regard to catheter location, analgetic potential and signs of local inflammation will be conducted. To ensure identical patients groups allocation will be strictly randomized. Furthermore, both patient groups will receive identical pain medication via the peridural catheter in situ. All catheter tips will be screened microbiologically after removal.
Status | Completed |
Enrollment | 140 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Patients aged > 18 years and operation with thoracic epidural Exclusion Criteria: Refusal of informed consent |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Germany | Heinrich Heine University, University Hospital Duesseldorf, Department of Anaesthesiology | Duesseldorf | NRW |
Lead Sponsor | Collaborator |
---|---|
Heinrich-Heine University, Duesseldorf | University of Osnabrueck |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in catheter position | Difference in catheter position between day of insertion and day of removal, measured in mm between catheter tip and skin niveau | 4-6 days | No |
Secondary | Secondary variables | Analgetic quality, incidence of catheter contamination, signs of local inflammmation and microbiological eamination of the catheter after removal | 4-6 days | Yes |
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