Phlebotomy
Conditions
Brief summary
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.
Interventions
DEVICEStimulation-assisted venous access
Stimulation-assisted venous access
OTHER20 guage cannula for IV, tourniquet optional
Standard IV cannulation using 20 ga needle, and use of tourniquet at discretion of nurse performing IV cannulation
Sponsors
Physeon GmbH
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| User Perception of IV cannulation difficulty, | 7 days | — |
| Subject Perception of Device stimulation | 7 days | — |
| Number of attempts required to achieve successful IV cannula placement | over a 24 hour period | number of punctures from initial puncture to successful IV cannulation |
| Subject Preception of IV cannulation pain | 7 days | — |
| Time required to achieve successful IV cannula placement | time from initial puncture to successful IV cannulation | — |
Outcome results
None listed