Vascular Access Device
Conditions
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.
Interventions
DEVICEMidline
Patient will receive a Midline catheter within 48h after disappearance of indication for CVC
DEVICEPVC
Patient will receive a standard PVC within 48h after disappearance of indication for CVC
Sponsors
Centre Hospitalier Departemental Vendee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
supportive care
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % 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
| Measure | Time frame | Description |
|---|---|---|
| Time consumption | until 28 days after randomisation | Total time of catheterisation, (measured from the entrance in patient room, to the exit) |
| Number of peripheral catheter-associated bacteremia | until 28 days after randomisation | — |
| ICU length of stay | Until discharge from ICU, an expected average of 12 days | — |
| hospital mortality | Until discharge from hospital, an expected average of 20 days | mortality in medical and surgical unit (no SSR or long stay) |
| 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) |
| Total number of puncture required for the insertion of a peripheral catheter | until 28 days after randomisation | — |
| Total number of peripheral catheter used | until 28 days after randomisation | — |
| Number of new CVC inserted | until 28 days after randomisation | — |
| ICU mortality | Until discharge from ICU, an expected average of 12 days | — |
| 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 colonized for per 1000 CVC /days | until 28 days after randomisation | — |
| Number of CVC-associated bacteremia | until 28 days after randomisation | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Colonization of skin at insert point of Midline catheter | until 28 days after randomisation | swabbing will be performed at every change of dressing |
| Thrombosis at Midline removal | until removal in ICU,an expected average of 10 days after insertion | thrombosis will be checked by ultrasound-echography if midline is removed in ICU |
| Colonization of Midline at removal | until removal,an expected average of 10 days after insertion | swabbing will be performed at catheter removal and its tips will be also analyzed |
Countries
France
Outcome results
None listed