ICU patients with an indication for a CVC line ICU patients that need a CVC line in an acute situation.
Conditions
Interventions
The coated CVC (16 or 20cm double lumen (7Fr and 8Fr)) will be inserted ultrasound guided into the left or right internal jugular vein or subclavian vein and left in place for a maximum of 29 days aft
Sponsors
Lipo Coat onderdeel van Universiteit Twente
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Adult (=18 years) ICU patients with a CVC indication for at least 5 days.Written informed consent has been obtained from a competent patient. An intensivist who is not involved in the patient's inclusion, admission, or initial treatment will assess the patient's decision-making capacity using a predefined step-by-step protocol (see Appendix 5 CIP). If there is any doubt regarding the patient's decision-making capacity, an independent surgeon (RHG) who is not involved in the patient's treatment will be asked to perform an additional assessment
Exclusion criteria
Exclusion criteria: < 18 years, Patients with severe coagulation disorders (e.g. thrombocyte count <50) CVC indication for less than 5 days.Patiënts with active infection at the insertion site.Patiënts with vascular injury near the insertion site.The patient or his legal representative has not been given consent to continue the study.Patients who are pregnant or breastfeeding.Patients that are incapacitatedOther contra-indications for CVC-use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of the coated CVCs in 25 ICU patients | — |
Secondary
| Measure | Time frame |
|---|---|
| Usability of the coated CVC. Analysis of bioburden on used CVC ex vivo as an indication for clinical antifouling performance. Characterization of used CVC using laboratory analysis techniques. | — |
Countries
Netherlands
Contacts
Public ContactM.J.G Damhuis
Medisch Spectrum Twente (MST)
Outcome results
None listed