Vascular Access Devices, Venous Puncture
Conditions
Keywords
Vascular access, Emergency Department, Long Peripheral Catheter, Peripheral Intra-Venous Catheter
Brief summary
The goal of this randomized controlled trial is to investigate the difference between LPC (mini-midline) and PIVC (peripheral venous catheter) on the need of further venipuncture for blood withdrawal or placement of a new vascular access. The main questions it aims to answer are: * Whether the number of patients with LPC and PIVC differ in terms of repeated venipunctures; * Whether the number of patients with LPC and PIVC differ in terms of adverse events associated with the use of such vascular catheters. Researchers will compare the proportion of patients with repeated venipunctures between LPC and PIVC arms.
Detailed description
A standard peripheral intravenous catheter (PIVC) or a mini-midline (LPC) will be placed according to routine clinical indications (i.e., for blood withdrawal and IV drug therapy) in patients seeking care at the Emergency Department. On admission at the Emergency Department triage desk, patients will be assigned a triage code according to clinical assessment by the triage nurse and will be evaluated as to the probability of being eventually admitted to hospital. Following enrollment, patients will be randomly assigned to receive LPC or PIVC. The follow-up period begins after catheter placement and continues through transfer to a hospital ward. During this period of catheter management, the insertion site and dressing will be monitored.
Interventions
PROCEDURELong Peripheral Catheter
PowerGlide Pro™ Midline Catheter
PROCEDUREPeripheral Intra-Venous Catheter
Venflon™ Pro Safety Needle Protected IntraVenous Cannula
Sponsors
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The statistician will be provided an anonymized dataset.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * High probability of hospital admission * Sufficient venous patrimony according to EA-DIVA scale score
Exclusion criteria
* Patients already having a venous access in place * Patients requiring life-saving treatments * Patients seeking ambulatory care * Patients unable to express informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in proportion | The catheter will be evaluated within 24 hours after the placement | Difference between the two study arms in the proportion of patients who required a venipuncture after insertion of the PIVC or the LPC. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events associated with use of LPC and PIVC | Adverse will be evaluated every 24 hours till the catheter removal | Number of adverse events (e.g., thrombophlebitis, extravasation, inflammation of the insertion site) monitored also using the Visual Infusion Phlebitis Score |
Countries
Italy
Outcome results
None listed