Fixation of Thoracic Epidurals Influencing Catheter-related Infections and Dislocation

Infection Clinical Trial

— TDPAFD  

Official title:

Fixation of Thoracic Epidural Catheters Influencing Catheter-related Infections and Dislocation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01402778
• Other study ID #: 02-VBTSPK-2011
• Status: Completed
• Phase: N/A
• First received: January 12, 2011
• Last updated: December 19, 2011
• Start date: January 2011
• Est. completion date: December 2011

Study information

• Verified date: December 2011
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Catheter-Related Infections
• Dislocation
• Dislocations
• Infection
• Line Colonisation
• Line Insertion Site

Locations

Country	Name	City	State
Germany	Heinrich Heine University, University Hospital Duesseldorf, Department of Anaesthesiology	Duesseldorf	NRW

Sponsors (2)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf	University of Osnabrueck

Country where clinical trial is conducted

Germany, 

Outcome

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