We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01402778
First Posted: July 26, 2011
Last Update Posted: December 20, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Osnabrueck
Information provided by (Responsible Party):
Klinik für Anästhesiologie, Heinrich-Heine University, Duesseldorf
  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:


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

Primary Outcome Measures:
  • Changes in catheter position [ Time Frame: 4-6 days ]
    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 ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: January 12, 2011
First Posted: July 26, 2011
Last Update Posted: December 20, 2011
Last Verified: December 2011

Additional relevant MeSH terms:
Infection
Communicable Diseases
Joint Dislocations
Catheter-Related Infections
Bone Diseases
Musculoskeletal Diseases
Wounds and Injuries