Midline Catheter and Its Impact on Central Lines Removal in ICU
- Conditions
- Vascular Access Device
- Interventions
- Device: PVCDevice: Midline
- Registration Number
- NCT03675711
- Lead Sponsor
- Centre Hospitalier Departemental Vendee
- Brief Summary
The study will evaluate 2 strategies to remove central venous catheter (CVC): in one part, the insertion of a midline catheter and in the other part, the conventional insertion of peripheral venous catheter (PVC)
- Detailed Description
Patients will be randomised when the last indication for CVC has disappeared, which means parenteral nutrition or vasopressors administration.
They will be randomised either in the midline group or in the PVC group.
* In the midline group, a midline catheter will try to be inserted before the 48th hour after last indication for CVC disappeared.
* In the PVC group: a PVC will try to be inserted before the 48th hour after last indication for CVC disappeared.
If successful, CVC will then be removed. If not, a PVC will try to be inserted daily till success or worthlessness of a venous line or death.
The presence of a CVC will be assessed at the 96th hour after disappearance of last CVC indication.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 83
- ≥18 years of age
- admitted to ICU since at least 48h
- with a perfusion CVC inserted
- requiring or having required invasive mechanical ventilation
- lack of formal indication to CVC maintenance (weaning of vasopressors and/or parenteral nutrition) since at least 24 hours
- indication to maintain a venous access
- Lack of patient or next of kin consent
- Personnel for insertion of midline catheter not available
- Admission in ICU before study start
- Admission following a transfer from another ICU
- Patient with an implantable port or a peripherally inserted central catheter (PICC Line)
- Known intolerance to components of study Midline device
- Past history of irradiation of insert area of midline catheter
- Past history of bilateral axillary lymph node dissection
- Pre-existing skin infection on upper limb
- Patient with a treatment-limitation decision
- Patient admitted after cardiac arrest with non-shockable rhythm
- Moribund
- Pregnancy, breastfeeding woman
- Patient under legal guardianship
- Patient hospitalized without consent and/or deprived of liberty by court's decision
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Peripheral venous Catheter PVC Pt. will receive a standard Peripheral venous catheter Midline Catheter Midline Pt. will receive midline catheters.
- Primary Outcome Measures
Name Time Method % of patient with a successful Removal of CVC at the 96th hour after disappearance of last indication for CVC H96 : 96th hour after disappearance of last indication for CVC A successful removal of CVC is defined as
* success of midline/PVC insertion at H96 and consequently CVC removal
* and no necessity for insertion of a new CVC within the 96 first hours
- Secondary Outcome Measures
Name Time Method Number of new CVC inserted until 28 days after randomisation Number of CVC colonized for per 1000 CVC /days until 28 days after randomisation Number of peripheral catheter-associated bacteremia until 28 days after randomisation hospital mortality Until discharge from hospital, an expected average of 20 days mortality in medical and surgical unit (no SSR or long stay)
Total number of puncture required for the insertion of a peripheral catheter until 28 days after randomisation Time consumption until 28 days after randomisation Total time of catheterisation, (measured from the entrance in patient room, to the exit)
ICU length of stay Until discharge from ICU, an expected average of 12 days Total number of peripheral catheter used until 28 days after randomisation Number of blood culture for research of catheter-related bloodstream infection (CRBSI) until 28 days after randomisation CVC dwell time from disappearance of CVC indication to last CVC removal or 28 days after randomisation if still in place Time of central catheter duration (hours)
Number of CVC-associated bacteremia until 28 days after randomisation Hospital length of stay Until discharge from hospital, an expected average of 20 days Hospital stay in medical and surgical unit (no follow-up and rehabilitation care unit or long stay)
ICU mortality Until discharge from ICU, an expected average of 12 days
Trial Locations
- Locations (1)
Centre Hospitalier Departemental Vendée
🇫🇷La Roche sur Yon, France