RIGHT IV Pilot Study

Smiths Medical, ASD, Inc.40 enrolled

Overview

The purpose of this pilot study is to collect the necessary information for determining the appropriate sample size of a statistically powered trial comparing the performance of two different blood control peripheral intravenous catheters.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Peripheral Intravenous Catheters

Interventions

ViaValve Safety IV CatheterDEVICE

Insertion of the peripheral intravenous catheters into both upper extremities of subjects

Insyte Autoguard BC [Blood Control] Shielded IV CatheterDEVICE

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years of age or older * Willing and able to independently sign an English Informed Consent * Have adequate veins for placement of IV catheters in both right and left upper extremities Exclusion Criteria: * Currently taking anti-coagulation medication * Have a known bloodborne disease or bleeding tendency * Have a known fear or adverse reaction to needles or blood * Women who are pregnant or nursing

Locations (1)

University of Minnesota Interprofessional Education and Resource Center

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

Clinical performance and acceptability

Primary outcome measure will be a composite of user ratings evaluating clinical performance and acceptability of each device via a 6-point Likert questionnaire.

Time frame: IV catheters will be inserted, secured to subjects, and then immediately removed. Data regarding the insertion process will then be immediately collected.

Data from ClinicalTrials.gov

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