Vital Peripheral Intravenous Catheter Feasibility

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-22

Study Completion Date

2022-03-04

Brief Summary

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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.

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Detailed Description

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Conditions

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Catheterization, Peripheral Venous

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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GPIV

If the eligibility criteria are fulfilled, up to 4 attempts will be made to achieve successful peripheral intravenous catheterization with the investigational device. All successive attempts will be made at a site different from the one(s) at which access has already failed.

Group Type EXPERIMENTAL

GPIV

Intervention Type DEVICE

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.

Interventions

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GPIV

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.

Intervention Type DEVICE

Other Intervention Names

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ViTal

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No