Intravenous Catheters Clinical Trial
Official title:
The Clinical Efficacy of Midline Catheters for Intravenous Therapy: a Randomized, Controlled Study
| Verified date | April 2020 |
| Source | University of Aarhus |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 120 |
| Est. completion date | July 30, 2019 |
| Est. primary completion date | July 30, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Department of Anaesthesiology and Intensive Care East Section, Aarhus University | Aarhus |
| Lead Sponsor | Collaborator |
|---|---|
| University of Aarhus |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Bloodsamples from catheter | Registration of number of blood samples taken from the midline catheter | through study completion, an average of 7 month | |
| Secondary | Problems with catheter bloodsampling | Registration of aspiration problems during bloodsampling in midline catheters | through study completion, an average of 7 month | |
| Secondary | Bloodsamples (conventional) | Registration of number of blood samples taken from conventional blood samples in both groups | through study completion, an average of 7 month | |
| Secondary | Patient satisfaction | Patient satisfaction on NRS score, 0 is very unsatisfied and 10 is very satisfied | through study completion, an average of 7 month | |
| Secondary | Nurse satisfaction | Nurse satisfaction on NRS score, 0 is very unsatisfied and 10 is very satisfied | through study completion, an average of 7 month | |
| Secondary | 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 | |
| Secondary | Rescue catherizations 1 | Rescue PVC's inserted (midline group) (no) | through study completion, an average of 7 month | |
| Secondary | Rescue catherizations 2 | Rescue central venous catheters including PICC line catheters inserted (no) | through study completion, an average of 7 month | |
| Secondary | Time consumption | Total time of cauterization, (measured from the entrance in patient room, to the exit) | through study completion, an average of 7 month | |
| Secondary | Catheter dwelltime | Time of catheter duration (hours) | through study completion, an average of 7 month | |
| Secondary | Fluid | Accumulated fluids infused (L) | through study completion, an average of 7 month | |
| Secondary | Treatment type | Type of medicine infused (all types) | through study completion, an average of 7 month | |
| Secondary | Treatment amount | Amount of medicine infused (L) | through study completion, an average of 7 month | |
| Secondary | Catheter related infections | Catheters removed due to suspected catheter-related infection (no) | through study completion, an average of 7 month | |
| Secondary | Thrombosis 1 | Thrombi visible at the catheter tip (no) | through study completion, an average of 7 month | |
| Secondary | Thrombosis 2 | Deep venous thrombosis of the ipsilateral arm (no) | through study completion, an average of 7 month | |
| Secondary | Thrombosis 3 | Superficial venous thrombosis of the ipsilateral arm (midline group) (no) | through study completion, an average of 7 month | |
| Secondary | Thrombosis 4 | Patients starting anti-thrombotic medicine due to thrombi generated by an IV catheter (no) | through study completion, an average of 7 month | |
| Secondary | Catheter discontinuation | Reasons for replacing catheters (all types) | through study completion, an average of 7 month | |
| Secondary | Insertion complication | Arterial punctures during catheter insertions (no) | through study completion, an average of 7 month | |
| Secondary | Insertion complication 2 | haematomas during catheter insertions (no) | through study completion, an average of 7 month | |
| Secondary | Insertion complication 3 | Misplaced catheters (no) | through study completion, an average of 7 month | |
| Secondary | Neuropraxia | Post-procedure median nerve palsy/neuropraxia (midline group) (no) | through study completion, an average of 7 month |