An interventional study of PVC and/or PICCline and Midline in Intravenous Catheters, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-07.
Sponsored by University of Aarhus · Not applicable, Interventional, and Other
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.
Exclusion Criteria:
Pt. will receive midline catheters. The outcomes will be registered and some patients will be examined once weekly for thrombosis with ultrasound.
Device: Midline
Pt. will receive the conventional treatment (PVC and/or PICCline/CVC). The outcomes will be registered.
Device: PVC and/or PICCline
Pt. will receive PVC and/or PICCline
Also known as: Conventional catheterization
Pt. will receive midline
Also known as: Powerglide
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.
Time frame: through study completion, an average of 7 month
Bloodsamples from catheter
Registration of number of blood samples taken from the midline catheter
Time frame: through study completion, an average of 7 month
Problems with catheter bloodsampling
Registration of aspiration problems during bloodsampling in midline catheters
Time frame: through study completion, an average of 7 month
Bloodsamples (conventional)
Registration of number of blood samples taken from conventional blood samples in both groups
Time frame: through study completion, an average of 7 month
Patient satisfaction
Patient satisfaction on NRS score, 0 is very unsatisfied and 10 is very satisfied
Time frame: through study completion, an average of 7 month
Nurse satisfaction
Nurse satisfaction on NRS score, 0 is very unsatisfied and 10 is very satisfied
Time frame: 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
Time frame: through study completion, an average of 7 month
Rescue catherizations 1
Rescue PVC's inserted (midline group) (no)
Time frame: through study completion, an average of 7 month
Rescue catherizations 2
Rescue central venous catheters including PICC line catheters inserted (no)
Time frame: through study completion, an average of 7 month
Time consumption
Total time of cauterization, (measured from the entrance in patient room, to the exit)
Time frame: through study completion, an average of 7 month
Catheter dwelltime
Time of catheter duration (hours)
Time frame: through study completion, an average of 7 month
Fluid
Accumulated fluids infused (L)
Time frame: through study completion, an average of 7 month
Treatment type
Type of medicine infused (all types)
Time frame: through study completion, an average of 7 month
Treatment amount
Amount of medicine infused (L)
Time frame: through study completion, an average of 7 month
Catheter related infections
Catheters removed due to suspected catheter-related infection (no)
Time frame: through study completion, an average of 7 month
Thrombosis 1
Thrombi visible at the catheter tip (no)
Time frame: through study completion, an average of 7 month
Thrombosis 2
Deep venous thrombosis of the ipsilateral arm (no)
Time frame: through study completion, an average of 7 month
Thrombosis 3
Superficial venous thrombosis of the ipsilateral arm (midline group) (no)
Time frame: through study completion, an average of 7 month
Thrombosis 4
Patients starting anti-thrombotic medicine due to thrombi generated by an IV catheter (no)
Time frame: through study completion, an average of 7 month
Catheter discontinuation
Reasons for replacing catheters (all types)
Time frame: through study completion, an average of 7 month
Insertion complication
Arterial punctures during catheter insertions (no)
Time frame: through study completion, an average of 7 month
Insertion complication 2
haematomas during catheter insertions (no)
Time frame: through study completion, an average of 7 month
Insertion complication 3
Misplaced catheters (no)
Time frame: through study completion, an average of 7 month
Neuropraxia
Post-procedure median nerve palsy/neuropraxia (midline group) (no)
Time frame: through study completion, an average of 7 month
Plan to share: No
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University of Aarhus