Cystic Fibrosis, Neoplasms
Conditions
Keywords
Vascular Access Devices, Implantable port, Flush interval, Catheter function, Catheter-related infection, Catheter tip location, Catheter tip thrombus, Catheter sleeve, Patient-reported outcome measure
Brief summary
A Totally Implantable Venous Access Device (TIVAD) that is no longer in use for intravenous therapy, should be flushed at established intervals to promote and maintain patency. No consensus has been established regarding the optimal duration of the interval between 2 maintenance sessions. This exploratory study will focus on catheter status under the current 3-monthly flush regimen.
Detailed description
A Totally Implantable Venous Access Device (TIVAD) or so called implantable port that is no longer in use for intravenous therapy, should be removed or flushed at established intervals to promote and maintain patency. The maintenance procedure consists of a 10 ml 0.9% sodium chloride pulsatile flush. No consensus has been established regarding the optimal duration of the interval between 2 maintenance sessions. In het university hospitals Leuven the current interval is 3 months. Studies confirmed the safety and efficacy of an extended maintenance interval to once every 4 months. Many patients have relatively poor compliance with their regular port flushing procedure. Clinicians tend to prolong the recommended interval or even to omit the maintenance procedure. Therefore in clinical practice, intervals vary widely among institutions. To the best of our knowledge, a comprehensive investigation of the risks related to catheter patency, bacterial colonization and catheter integrity, has never been performed in patients whose port is electively removed using a 3 months flushing maintenance regimen. To assess the impact of the maintenance interval, patients will be included in the study if the patient's TIVAD is not being used for regularly therapy for a total period of at least one year. This exploratory study will focus on catheter function and colonisation, tip position and tip thrombosis, sleeve formation, removal problems and also patient experiences at elective planned TIVAD removal therapy.
Interventions
OTHEREvaluation of the catheter function
Catheter function will be measured by the CINAS (Catheter injection and aspiration classification)
OTHERCatheter tip location, thrombus, sleeve and device damage visualization
Catheter tip location, thrombus, sleeve and device damage will be visualized by linogram
OTHERCatheter-related colonization
TIVAD colonization will be investigated by microbiological culture of the tip and chamber content
OTHERpatient-reported outcome measures (PROM) related to the presence of the TIVAD
PROM will evaluate patient's experiences regarding the TIVAD insertion, dwell time, and removal using the Leuven Patient Reported Experiences at Port removal (Leuven PREP) questionnaire.
OTHERMacroscopic evaluation of the port chamber and catheter
Macroscopic evaluation of the port chamber and catheter will be performed after port removal.
Sponsors
B. Braun Medical SA
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients of 18 years and older, with a TIVAD that is no longer used for intravenous therapy on a regular basis for the past 365 days after completing initially planned treatment. * Patients planned for an elective TIVAD removal under local anaesthesia. * Patients able to participate in the study and willing to sign an informed consent. * Patients able to understand and read Dutch.
Exclusion criteria
• History of fever and/or chills following last flushing procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TIVAD function | during the 1 day of TIVAD removal, before the linogram | will be assessed in terms of both injection and aspiration abilities. The ability is scored as easy, difficult or impossible along the Catheter Injection and Aspiration (CINAS) classification. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Catheter tip position visualization by fluoroscopy | during the 1 day of TIVAD removal, just before the linogram | The patient will be positioned in a nearly standing position with chest elevation of 17° |
| Port chamber filling, sleeve formation, sleeve extend, catheter tip thrombosis and damage in port chamber or catheter trajectory | during the 1 day of TIVAD removal | will be visualised by linogram (digital substraction angiography) |
| Catheter tip and port chamber culture | during the 1 day of TIVAD removal (following TIVAD removal) | microbial culture |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported outcome measure | during the 1 day of TIVAD removal | Patient's experiences will be collected by means of the Leuven Patient Reported Experiences at Port removal (Leuven PREP) questionnaire a self-reported 25-items questionnaire |
Countries
Belgium
Outcome results
None listed