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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
History of Changes
  Purpose

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.


Condition
Dislocation
Infection
Line Colonisation
Line Insertion Site

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fixation of Thoracic Epidural Catheters Influencing Catheter-related Infections and Dislocation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Heinrich-Heine University, Duesseldorf:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 140
Study Start Date: January 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cather fixation by tunneling and suture
Catheter fixation by adhesive tape

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients aged > 18 years

Criteria

Inclusion Criteria:

Patients aged > 18 years and operation with thoracic epidural

Exclusion Criteria:

Refusal of informed consent

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01402778

Locations
Germany
Heinrich Heine University, University Hospital Duesseldorf, Department of Anaesthesiology
Duesseldorf, NRW, Germany, 40225
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
University of Osnabrueck
Investigators
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
  More Information

No publications provided

Responsible Party: Klinik für Anästhesiologie, Prof. Dr. Peter Kienbaum, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT01402778     History of Changes
Other Study ID Numbers: 02-VBTSPK-2011
Study First Received: January 12, 2011
Last Updated: December 19, 2011
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Dislocations
Catheter-Related Infections
Wounds and Injuries
Infection

ClinicalTrials.gov processed this record on May 23, 2013