Assess Veinplicity Venous Access Device Safety and Effectiveness

Study Overview
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Brief Summary
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The purpose of this study was to examine the Veinplicity Device as an adjunctive IV cannulation tool in subjects with a history of difficult to access veins. The Veinplicity Device is intended to improve venous access rates in compromised patients by taking advantage of the increased circulation that results from provoked muscle stimulation. The study collected information about the device, intravenous access, user and patient perceptions for IV access, and any device or procedural complications or other adverse events. Device use was examined with patients in both a prone and upright position.

Official Title
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A Prospective, Single Center, Randomized, Cross-over Clinical Trial to Assess the Safety and Effectiveness of the Veinplicity Venous Access Device

Conditions
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Phlebotomy

Intervention / Treatment
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* Device: Stimulation-assisted venous access
* Other: 20 guage cannula for IV, tourniquet optional


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject ≥ 18 years of age Subject with history of failed venous access, venipuncture, or IV cannula placement Subject agreed to required follow-up Subject provided written, informed consent Exclusion Criteria: Subject currently had compromised skin on either forearm or hand Subject currently on any blood thinning medication other than 81mg of aspirin Subject had been diagnosed with peripheral neuropathy, has had a complex fracture or surgery in the forearm, or has other condition that diminishes sensation in one or both arms, hands or fingers Subject had a demand type pacemaker or defibrillator Subject is female of child-bearing potential and had a positive urine pregnancy test Subject had a history of seizure, convulsions or epilepsy Subject had a known allergy to Epsom salts Subject had any other condition that may affect the ability to complete study requirements

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stimulation-assisted<br>All subjects received treatment (stimulation-assisted) with the Veinplicity Device per the Instructions for Use. The subject underwent standard IV cannulation using a 20 gauge cannula into the available vein immediately after completion of device stimulation. Use of a tourniquet was at the discretion of the nurse performing the IV cannulation. | Device: Stimulation-assisted venous access<br>* Stimulation-assisted venous access<br>* Other names: Veinplicity Device;Other: 20 guage cannula for IV, tourniquet optional<br>* Standard IV cannulation using 20 ga needle, and use of tourniquet at discretion of nurse performing IV cannulation<br>|
| Other: standard IV cannulation<br>The subject underwent standard IV cannulation using a 20 gauge cannula into the best available vein. Use of a tourniquet was at the discretion of the nurse performing the IV cannulation. | Other: 20 guage cannula for IV, tourniquet optional<br>* Standard IV cannulation using 20 ga needle, and use of tourniquet at discretion of nurse performing IV cannulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of successful venous access on the first attempt. |  | 7 days | 
| Rate of adverse events associated with either the treatment or the venous access site. |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| User Perception of IV cannulation difficulty, |  | 7 days | 
| Subject Preception of IV cannulation pain |  | 7 days | 
| Subject Perception of Device stimulation |  | 7 days | 
| Time required to achieve successful IV cannula placement |  | time from initial puncture to successful IV cannulation | 
| Number of attempts required to achieve successful IV cannula placement | number of punctures from initial puncture to successful IV cannulation | over a 24 hour period |