DislocationTDPAFDNCT01402778
Fixation of Thoracic Epidurals Influencing Catheter-related Infections and Dislocation
An observational study of Dislocation and Infection, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dislocation, Infection, Line Colonisation
- How many people
- 140 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged > 18 years
Who may be able to join
- Patients aged > 18 years and operation with thoracic epidural
Who cannot join
- Refusal of informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Heinrich Heine University, University Hospital Duesseldorf, Department of Anaesthesiology
Düsseldorf, North Rhine-Westphalia, 40225
About this study
Official title: 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.
- Conditions
- Dislocation, Infection, Line Colonisation, Line Insertion Site
- Medical subject headings
- Joint Dislocations, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cather fixation by tunneling and suture | Not described | |
| Catheter fixation by adhesive tape | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4-6 days
Secondary outcomes (1)
Secondary variables
Analgetic quality, incidence of catheter contamination, signs of local inflammmation and microbiological eamination of the catheter after removal
Measured: 4-6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DislocationStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Collaborators
- University of Osnabrueck
- Responsible party
- Principal investigator, Klinik für Anästhesiologie, Heinrich-Heine University, Duesseldorf
- Investigators
- Peter Kienbaum, Professor, Principal investigator, Heinrich Heine University, Department of Anaesthesiology, Chairman: Univ-Prof. Dr.med. B. PannenMartin Beiderlinden, Privatdozent, Principal investigator, Department of Anaesthesia, Marienhospital Osnabrueck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01402778
- Sponsor's protocol ID
- 02-VBTSPK-2011
- Acronym
- TDPAFD
- Status last verified
- Dec 2011
- First submitted
- 12 Jan 2011
- Last updated
- 20 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fixation of Thoracic Epidural Catheters Influencing Catheter-related Infections and Dislocation
- ClinicalTrials.gov ID
- NCT01402778
- Acronym / sponsor ID
- TDPAFD / 02-VBTSPK-2011
- Conditions
- Dislocation, Infection, Line Colonisation, Line Insertion Site
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Collaborators
- University of Osnabrueck
- Study start
- Jan 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 26 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cather fixation by tunneling and suture | – | – |
| Catheter fixation by adhesive tape | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged > 18 years
Key inclusion criteria (1 listed)
- Patients aged > 18 years and operation with thoracic epidural
Key exclusion criteria (1 listed)
- Refusal of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Secondary variables
Time frame: 4-6 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Kienbaum, Professor principal investigator
Heinrich Heine University, Department of Anaesthesiology, Chairman: Univ-Prof. Dr.med. B. Pannen
Martin Beiderlinden, Privatdozent principal investigator
Department of Anaesthesia, Marienhospital Osnabrueck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dislocation and Infection, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in catheter position (time frame: 4-6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2011.