RIGHT IV Pilot Study (RIGHT IV)

May 25, 2016 updated by: Smiths Medical, ASD, Inc.

Post-Market Study Comparing the Clinical Performance Two Blood Control Safety Peripheral Intravenous Catheters: A Pilot Study

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Interprofessional Education and Resource Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ViaValve Safety IV Catheter
Catheter insertion using the ViaValve Safety IV Catheter.
Device: ViaValve Safety IV Catheter
Insertion of the peripheral intravenous catheters into both upper extremities of subjects
Active Comparator: Insyte Autoguard BC [Blood Control] Shielded IV Catheter
Catheter insertion using the Insyte Autoguard BC Shielded IV Catheter
Device: Insyte Autoguard BC [Blood Control] Shielded IV Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical performance and acceptability
Time Frame: IV catheters will be inserted, secured to subjects, and then immediately removed. Data regarding the insertion process will then be immediately collected.
Primary outcome measure will be a composite of user ratings evaluating clinical performance and acceptability of each device via a 6-point Likert questionnaire.
IV catheters will be inserted, secured to subjects, and then immediately removed. Data regarding the insertion process will then be immediately collected.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Smiths Medical, ASD, Inc.

Investigators

  • Principal Investigator: Lori Schwartz, MBA, MSN, RN, PHN, Smiths Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

February 8, 2013

First Submitted That Met QC Criteria

February 14, 2013

First Posted (Estimate)

February 15, 2013

Study Record Updates

Last Update Posted (Estimate)

May 26, 2016

Last Update Submitted That Met QC Criteria

May 25, 2016

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RIGHT IV Pilot Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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