Fixation of Thoracic Epidurals Influencing Catheter-related Infections and Dislocation

NCT01402778 | Completed

• 1 other identifier: 02-VBTSPK-2011
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dislocation; Infection; Line Colonisation; Line Insertion Site

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Secondary variables

  4-6 days

Study Arms (2)

Cather fixation by tunneling and suture

Catheter fixation by adhesive tape

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients aged \> 18 years

You may qualify if:

• Patients aged \> 18 years and operation with thoracic epidural

You may not qualify if:

• Refusal of informed consent

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead
• University of Osnabrueck: collaborator

Study Sites (1)

Heinrich Heine University, University Hospital Duesseldorf, Department of Anaesthesiology

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

MeSH Terms

Conditions

Joint Dislocations; Infections

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Peter Kienbaum

Study Record Dates

• First Submitted: January 12, 2011
• First Posted: July 26, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 20, 2011

Record last verified: 2011-12

Locations

DE (1)