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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stimulation-assisted | Experimental | 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. |
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| standard IV cannulation | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stimulation-assisted venous access | Device | Stimulation-assisted venous access |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leela Vrishabhendra, MD | Medpace Medical Device | Principal Investigator |
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| 20 guage cannula for IV, tourniquet optional | Other | Standard IV cannulation using 20 ga needle, and use of tourniquet at discretion of nurse performing IV cannulation |
|
| 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 |