Assess Veinplicity Venous Access Device Safety and Effectiveness
Not Applicable
Completed
- Conditions
- Phlebotomy
- Interventions
- Device: Stimulation-assisted venous accessOther: 20 guage cannula for IV, tourniquet optional
- Registration Number
- NCT03109405
- Lead Sponsor
- Physeon GmbH
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description stimulation-assisted Stimulation-assisted venous access 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. stimulation-assisted 20 guage cannula for IV, tourniquet optional 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. standard IV cannulation 20 guage cannula for IV, tourniquet optional 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Subject Perception of Device stimulation 7 days User Perception of IV cannulation difficulty, 7 days Subject Preception of IV cannulation pain 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 over a 24 hour period number of punctures from initial puncture to successful IV cannulation