The Clinical Efficacy of Midline Catheters

Study Overview
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Brief Summary
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The study will evaluate the clinical efficacy of midline catheters compared to conventional treatment in patients with an expected intravenous therapy duration of more than 5 days. Patients will be randomized in a 1:1 ratio. The study will include 120 patient. Endpoints include insertion of CVSs, peripheral venous catheters, catheter patency and a number of possible complications.

Official Title
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The Clinical Efficacy of Midline Catheters for Intravenous Therapy: a Randomized, Controlled Study

Conditions
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Intravenous Catheters

Intervention / Treatment
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* Device: PVC and/or PICCline
* Device: Midline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admission to the Department of Infectious Disease or Department of Heart Disease. ≥18 years of age Expected requirement for iv. therapy >5 days from the day of enrolment as evaluated by a specialist in infectious diseases. Mentally competency Exclusion Criteria: Lack of patient consent Requirement for a CVC before study eligibility screening or anticipation of an absolute indication for CVC inserted within 24 hours of screening Personnel for insertion of midline catheter not available

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 60 patients in each group, with a total of 2 groups
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Midline<br>Pt. will receive midline catheters. The outcomes will be registered and some patients will be examined once weekly for thrombosis with ultrasound. | Device: Midline<br>* Pt. will receive midline<br>* Other names: Powerglide;|
| Active Comparator: Conventional<br>Pt. will receive the conventional treatment (PVC and/or PICCline/CVC). The outcomes will be registered. | Device: PVC and/or PICCline<br>* Pt. will receive PVC and/or PICCline<br>* Other names: Conventional catheterization;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reducing the use of CVC and PVC | The fraction of patients requiring either a CVC - including PICC line - or require ≥ 4PVC insertions during the current admittance to the hospital, including follow-up intravenous therapy. | through study completion, an average of 7 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bloodsamples from catheter | Registration of number of blood samples taken from the midline catheter | through study completion, an average of 7 month | 
| Problems with catheter bloodsampling | Registration of aspiration problems during bloodsampling in midline catheters | through study completion, an average of 7 month | 
| Bloodsamples (conventional) | Registration of number of blood samples taken from conventional blood samples in both groups | through study completion, an average of 7 month | 
| Patient satisfaction | Patient satisfaction on NRS score, 0 is very unsatisfied and 10 is very satisfied | through study completion, an average of 7 month | 
| Nurse satisfaction | Nurse satisfaction on NRS score, 0 is very unsatisfied and 10 is very satisfied | through study completion, an average of 7 month | 
| Painscore | Accumulated NRS pain score for all IV catheter insertions. 0 is no pain and 10 is worst imaginable pain | through study completion, an average of 7 month | 
| Rescue catherizations 1 | Rescue PVC's inserted (midline group) (no) | through study completion, an average of 7 month | 
| Rescue catherizations 2 | Rescue central venous catheters including PICC line catheters inserted (no) | through study completion, an average of 7 month | 
| Time consumption | Total time of cauterization, (measured from the entrance in patient room, to the exit) | through study completion, an average of 7 month | 
| Catheter dwelltime | Time of catheter duration (hours) | through study completion, an average of 7 month | 
| Fluid | Accumulated fluids infused (L) | through study completion, an average of 7 month | 
| Treatment type | Type of medicine infused (all types) | through study completion, an average of 7 month | 
| Treatment amount | Amount of medicine infused (L) | through study completion, an average of 7 month | 
| Catheter related infections | Catheters removed due to suspected catheter-related infection (no) | through study completion, an average of 7 month | 
| Thrombosis 1 | Thrombi visible at the catheter tip (no) | through study completion, an average of 7 month | 
| Thrombosis 2 | Deep venous thrombosis of the ipsilateral arm (no) | through study completion, an average of 7 month | 
| Thrombosis 3 | Superficial venous thrombosis of the ipsilateral arm (midline group) (no) | through study completion, an average of 7 month | 
| Thrombosis 4 | Patients starting anti-thrombotic medicine due to thrombi generated by an IV catheter (no) | through study completion, an average of 7 month | 
| Catheter discontinuation | Reasons for replacing catheters (all types) | through study completion, an average of 7 month | 
| Insertion complication | Arterial punctures during catheter insertions (no) | through study completion, an average of 7 month | 
| Insertion complication 2 | haematomas during catheter insertions (no) | through study completion, an average of 7 month | 
| Insertion complication 3 | Misplaced catheters (no) | through study completion, an average of 7 month | 
| Neuropraxia | Post-procedure median nerve palsy/neuropraxia (midline group) (no) | through study completion, an average of 7 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Midline catheter, peripheral venous catheter, central venous catheter, complication rate