Intravenous Catheters
Conditions
Keywords
Midline catheter, peripheral venous catheter, central venous catheter, complication rate
Brief summary
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.
Interventions
DEVICEPVC and/or PICCline
Pt. will receive PVC and/or PICCline
DEVICEMidline
Pt. will receive midline
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
60 patients in each group, with a total of 2 groups
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reducing the use of CVC and PVC | through study completion, an average of 7 month | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Problems with catheter bloodsampling | through study completion, an average of 7 month | Registration of aspiration problems during bloodsampling in midline catheters |
| Bloodsamples (conventional) | through study completion, an average of 7 month | Registration of number of blood samples taken from conventional blood samples in both groups |
| Patient satisfaction | through study completion, an average of 7 month | Patient satisfaction on NRS score, 0 is very unsatisfied and 10 is very satisfied |
| Nurse satisfaction | through study completion, an average of 7 month | Nurse satisfaction on NRS score, 0 is very unsatisfied and 10 is very satisfied |
| Painscore | through study completion, an average of 7 month | Accumulated NRS pain score for all IV catheter insertions. 0 is no pain and 10 is worst imaginable pain |
| Rescue catherizations 1 | through study completion, an average of 7 month | Rescue PVC's inserted (midline group) (no) |
| Rescue catherizations 2 | through study completion, an average of 7 month | Rescue central venous catheters including PICC line catheters inserted (no) |
| Time consumption | through study completion, an average of 7 month | Total time of cauterization, (measured from the entrance in patient room, to the exit) |
| Catheter dwelltime | through study completion, an average of 7 month | Time of catheter duration (hours) |
| Fluid | through study completion, an average of 7 month | Accumulated fluids infused (L) |
| Treatment type | through study completion, an average of 7 month | Type of medicine infused (all types) |
| Bloodsamples from catheter | through study completion, an average of 7 month | Registration of number of blood samples taken from the midline catheter |
| Catheter related infections | through study completion, an average of 7 month | Catheters removed due to suspected catheter-related infection (no) |
| Thrombosis 1 | through study completion, an average of 7 month | Thrombi visible at the catheter tip (no) |
| Thrombosis 2 | through study completion, an average of 7 month | Deep venous thrombosis of the ipsilateral arm (no) |
| Thrombosis 3 | through study completion, an average of 7 month | Superficial venous thrombosis of the ipsilateral arm (midline group) (no) |
| Thrombosis 4 | through study completion, an average of 7 month | Patients starting anti-thrombotic medicine due to thrombi generated by an IV catheter (no) |
| Catheter discontinuation | through study completion, an average of 7 month | Reasons for replacing catheters (all types) |
| Insertion complication | through study completion, an average of 7 month | Arterial punctures during catheter insertions (no) |
| Insertion complication 2 | through study completion, an average of 7 month | haematomas during catheter insertions (no) |
| Insertion complication 3 | through study completion, an average of 7 month | Misplaced catheters (no) |
| Neuropraxia | through study completion, an average of 7 month | Post-procedure median nerve palsy/neuropraxia (midline group) (no) |
| Treatment amount | through study completion, an average of 7 month | Amount of medicine infused (L) |
Countries
Denmark
Outcome results
None listed