Catheter Failure Clinical Trial
Official title:
Skin Antisepsis With Chlorhexidine-Alcohol Versus Povidone Iodine-Alcohol, Combined or Not With Use of a Bundle of New Devices, for Prevention of Intravascular-catheter Colonization and Catheter Failure: An Open Label, Single Center, Randomized Controlled, Two-by-two Factorial Trial
Short peripheral intravenous catheters (PVC) are the most frequently used invasive medical
devices in hospitals. Unfortunately, PVCs often fail before the end of treatment due to the
occurrence of complications, which can be mechanical, vascular or infectious. Complications
lead to infusion failure and device replacement, which results in interrupted therapy, pain
associated with resiting and increased health care costs for resources and staff time.
Catheter related bloodstream infections (CR-BSIs) prolong hospitalization and increase
treatment costs and mortality.
Prevention of these complications is based on the respect of hygiene rules and the use of
bio-compatible catheters. The choice of the antiseptic solution for skin disinfection is key.
Similarly, the use of new technologies such as catheters designed to minimize blood exposure,
zero-reflux needleless-connectors, disinfecting caps, and flushing PVCs before and after each
medication administration to maintain catheter patency are of theoretical interest, but
little scientific data support their use in routine.
The primary objectives of this study are, first, to demonstrate that skin preparation with 2%
chlorhexidine (CHG)-70% isopropanol decreases the risk of PVC colonization compared to skin
preparation with 5% povidone iodine (PVI)-69% ethanol. Second, to demonstrate that use of a
bundle of technologies including a new PVC, zero-reflux needless-connectors, disinfecting
caps, and single-use prefilled flush syringes extends the time between catheter insertion and
catheter failure.
The secondary objectives are to compare between the four study group incidence of phlebitis,
accidental catheter removal, infiltration, catheter occlusion, CR-BSI, local infection,
all-cause bloodstream infections, catheter colonization, duration of catheter remaining in
place without complication, length of hospital stay, safety and patient satisfaction.
The CLEAN 3 study is an open-label, single centre, investigator-initiated, randomised,
four-parallel group, two-by-two factorial trial. Patients requiring PVC for an expected 48 h
will be randomised in one of four groups according to skin disinfection method and type of
devices used. Randomization will be carried out through a secure web-based randomization
system. Inclusions are expected to begin in January 2019 and continue until July 2019, once
the number of catheters required has been reached.
Patients will be enrolled at the Emergency department of the Poitiers University Hospital
before being hospitalised in one of five wards (neurology, neurology, pneumology, internal
medicine and downstream emergency unit).
n/a