Midline Catheter and Its Impact on Central Lines Removal in ICU

Study Overview
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Brief Summary
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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
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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.

Official Title
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Midline Catheter and Its Impact on Central Lines Removal in ICU

Conditions
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Vascular Access Device

Intervention / Treatment
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* Device: Midline
* Device: PVC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: supportive care
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Midline Catheter<br>Pt. will receive midline catheters. | Device: Midline<br>* Patient will receive a Midline catheter within 48h after disappearance of indication for CVC<br>|
| Active Comparator: Standard Peripheral venous Catheter<br>Pt. will receive a standard Peripheral venous catheter | Device: PVC<br>* Patient will receive a standard PVC within 48h after disappearance of indication for CVC<br>* Other names: Conventional catheterization;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of patient with a successful Removal of CVC at the 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 | H96 : 96th hour after disappearance of last indication for CVC | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Time consumption | Total time of catheterisation, (measured from the entrance in patient room, to the exit) | 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 | Time of central catheter duration (hours) | from disappearance of CVC indication to last CVC removal or 28 days after randomisation if still in place | 
| Number of CVC colonized for per 1000 CVC /days |  | until 28 days after randomisation | 
| Number of CVC-associated bacteremia |  | until 28 days after randomisation | 
| 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 length of stay | Hospital stay in medical and surgical unit (no follow-up and rehabilitation care unit or long stay) | Until discharge from hospital, an expected average of 20 days | 
| ICU mortality |  | Until discharge from ICU, an expected average of 12 days | 
| hospital mortality | mortality in medical and surgical unit (no SSR or long stay) | Until discharge from hospital, an expected average of 20 days |