Catheterization, Peripheral Venous
Conditions
Brief summary
The goal of this clinical trial is to assess the safety and efficacy of ViTal, a peripheral intravenous catheter with a glide-on-contact design of the plastic canula tip, in peripheral intravenous catheterization in individuals requiring intravenous therapy or blood sampling. The main question it aims to answer is: What is the first attempt success rate of the peripheral intravenous catheterization done using the study device? Participants will be asked to grade the pain they experienced when attempts were made to insert the study device into their peripheral vein.
Interventions
DEVICEGPIV
The investigational device is a peripheral intravenous catheter with a passive fully automatic needlestick protection, with a glide-on-contact design of the plastic cannula tip featuring asymmetry, with the negative, convex slope in the plane perpendicular to the longitudinal axis of the tip resulting in bottom part of the cannula being shorter.
Sponsors
Embrace Medical Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female age ≥ 18. 2. Requiring blood sample collection (roll-in subjects) or planned for PIVC (analyzable subjects) 3. Signed informed consent.
Exclusion criteria
1. Pregnancy or lactation. 2. Requirement for emergent IV placement (patient's condition would be compromised if there is a delay in IV placement). 3. Previous venous grafts or surgery at the target vessel access site.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First attempt success rate | Periprocedural | Proportion, in percent, of subjects with successful peripheral intravenous catheterization Successful PIVC is defined as withdrawal of non-pulsatile blood or infusion of saline without evidence of extravasation. Failed PIVC is defined as extravasation with initial infusion, inability to draw blood, physician or nurse intervention for access or inability to obtain access. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device- and procedure-related adverse events | Periprocedural | Incidence of the device- and procedure-related adverse events |
Countries
Dominican Republic
Outcome results
None listed