RIGHT IV Pilot Study

Not Applicable

Completed

• Conditions: Peripheral Intravenous Catheters
• Interventions: Device: Insyte Autoguard BC [Blood Control] Shielded IV Catheter; Device: ViaValve Safety IV Catheter

• Registration Number: NCT01792778
• Lead Sponsor: Smiths Medical, ASD, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Study First Submitted: 2013-02-08
• Study First Submitted QC: 2013-02-14
• Study First Posted: 2013-02-15
• Status Verified: 2014-05
• Last Update Submitted: 2016-05-25
• Last Update Posted: 2016-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Insyte Autoguard BC [Blood Control] Shielded IV Catheter	Insyte Autoguard BC [Blood Control] Shielded IV Catheter	Catheter insertion using the Insyte Autoguard BC Shielded IV Catheter
ViaValve Safety IV Catheter	ViaValve Safety IV Catheter	Catheter insertion using the ViaValve Safety IV Catheter.

Primary Outcome Measures

Name	Time	Method
Clinical performance and acceptability	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.

Trial Locations

Locations (1)

University of Minnesota Interprofessional Education and Resource Center; 🇺🇸 Minneapolis, Minnesota, United States