Fixation of Thoracic Epidurals Influencing Catheter-related Infections and Dislocation (TDPAFD)

This study has been completed.
Sponsor:
Collaborator:
University of Osnabrueck
Information provided by (Responsible Party):
Klinik für Anästhesiologie, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT01402778
First received: January 12, 2011
Last updated: December 19, 2011
Last verified: December 2011

January 12, 2011
December 19, 2011
January 2011
December 2011   (final data collection date for primary outcome measure)
Changes in catheter position [ Time Frame: 4-6 days ] [ Designated as safety issue: No ]
Difference in catheter position between day of insertion and day of removal, measured in mm between catheter tip and skin niveau
Same as current
Complete list of historical versions of study NCT01402778 on ClinicalTrials.gov Archive Site
Secondary variables [ Time Frame: 4-6 days ] [ Designated as safety issue: Yes ]
Analgetic quality, incidence of catheter contamination, signs of local inflammmation and microbiological eamination of the catheter after removal
Same as current
Not Provided
Not Provided
 
Fixation of Thoracic Epidurals Influencing Catheter-related Infections and Dislocation
Fixation of Thoracic Epidural Catheters Influencing Catheter-related Infections and Dislocation

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients aged > 18 years

  • Dislocation
  • Infection
  • Line Colonisation
  • Line Insertion Site
Not Provided
  • Cather fixation by tunneling and suture
  • Catheter fixation by adhesive tape
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

Patients aged > 18 years and operation with thoracic epidural

Exclusion Criteria:

Refusal of informed consent

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01402778
02-VBTSPK-2011
No
Klinik für Anästhesiologie, Heinrich-Heine University, Duesseldorf
Heinrich-Heine University, Duesseldorf
University of Osnabrueck
Principal Investigator: Peter Kienbaum, Professor Heinrich Heine University, Department of Anaesthesiology, Chairman: Univ-Prof. Dr.med. B. Pannen
Principal Investigator: Martin Beiderlinden, Privatdozent Department of Anaesthesia, Marienhospital Osnabrueck
Heinrich-Heine University, Duesseldorf
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP