Clinical trial NCT03752632: Veinplicity for Improved Venous Access: The VIVA Trial
Official title: Veinplicity for Improved Venous Access: The VIVA Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Difficult-to-access Veins for Intravenous Cannulation
Keywords: intravenous
peripheral vein
cannulation
IV access
Lead sponsor: Physeon GmbH
Sponsor class: INDUSTRY
Collaborators: name: Regulatory and Clinical Research Institute Inc
First posted: 2018-11-26
Enrollment: 120
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the safety and effectiveness of the Veinplicity device to improve the visualization and palpability of difficult-to-access veins for intravenous cannulation.

Detailed description: This is a prospective, randomized controlled study that will assess ability of Veinplicity to improve successful peripheral vein cannulation at the first stick in enrolled subjects. Potential subjects will undergo a peripheral vein assessment by a study clinician, which is standard of care prior to peripheral vein cannulation (PVC) for the establishment of intravenous (IV) access. Adults who are assessed as having "fair or poor" vein quality will be consented, enrolled and randomized into the study. Subjects will be randomized in a 1:1 ratio to either (1) tourniquet alone (control group); or (2) Veinplicity with tourniquet (treatment group). The primary endpoint is first-stick success. Clinicians will use an 18-, 20- or 22-gauge cannula. Clinician and subject satisfaction will be separately assessed using surveys on Day 0. Subjects in both groups will be followed for one day (either phone or in-hospital visit) after enrollment for safety. Qualified study clinicians must have at least one year of experience inserting peripheral IVs and must perform an average of five PVCs per week. The primary hypothesis to be tested is: Veinplicity with tourniquet is superior to tourniquet alone for successful peripheral vein access at first stick when used to cannulate subjects assessed as having a fair or poor level of vein quality. It is expected that this study will enroll approximately 246 subjects; 123 per study group. It is expected that up to five sites will be involved in this study. A planned interim analysis will be conducted to reassess the study planned sample size when approximately 50% of subjects have been enrolled. Enrollment will not stop during the interim analysis activities. Safety will be evaluated by the collection and analysis of the incidence and severity of all procedure- and/or device-related adverse events through the Day 1 phone call/visit.

Eligibility criteria: Inclusion Criteria:

* Subject is ≥ 22 years old.
* Subject is assessed as having fair or poor vein quality.
* Subject's both arms are suitable for cannulation.
* Subject will not suffer harm from a delay in having an IV established as determined by the treating clinician.

Exclusion Criteria:

* Subject has existing intravenous access.
* Subject has a planned or existing intra-arterial access.
* Subject has broken, infected or irritated skin and/or dermatological conditions, e.g., eczema, psoriasis and/or allergic reactions, on either forearm.
* Subject has an active implantable medical device.
* Subject wears a transdermal drug delivery patch on her/his forearm.
* Subject has an active/suspected deep vein thrombosis or thrombophlebitis, impaired circulation, impaired sensation, active/uncontrolled bleeding, recently radiated tissue, recent fracture, recent injury or surgery resulting in blood loss \> 100 mL, osteoporosis, localized abscess, localized tuberculosis, and/or a chronic wound with potential underlying osteomyelitis.
* Subject has impaired cognition or communication (unable to provide accurate feedback).
* Subject has a history of seizures and/or epilepsy, and/or a recent seizure, possible recent seizure or a history of possible seizures.
* Subject is pregnant and/or breastfeeding at the time of study enrollment.
* Subject has, at the site of or in between Veinplicity electrode application sites, an active/suspected malignancy.

Primary outcomes:
measure: First-stick success when accessing a peripheral vein for cannulation
timeFrame: Day 0
measure: Device and/or procedure-related adverse events
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
measure: Number of attempted sticks to successful vein access
timeFrame: Day 0
measure: Total procedure time
timeFrame: Day 0
measure: Time to first-stick success
timeFrame: Day 0
measure: Subject Satisfaction Survey question for control subject's: Past IV starts have been difficult, uncomfortable or painful.
timeFrame: Day 0 after completion of the study procedure
measure: Subject Satisfaction Survey question for control subject's: Today, my IV was started easily.
timeFrame: Day 0 after completion of the study procedure
measure: Subject Satisfaction Survey question for control subject's: Pain associated with IV start procedure today.
timeFrame: Day 0 after completion of the study procedure
measure: Subject Satisfaction Survey question for control subject's: Pain associated with today's IV start compared to past IV starts.
timeFrame: Day 0 after completion of the study procedure
measure: Subject Satisfaction Survey question for control subject's: Anxiety associated with the IV start procedure today.
timeFrame: Day 0 after completion of the study procedure
measure: Subject Satisfaction Survey question for control subject's: Anxiety associated with today's IV start compared to past IV starts.
timeFrame: Day 0 after completion of the study procedure
measure: Subject Satisfaction Survey question for control subject's: Overall, I was satisfied with today's IV start.
timeFrame: Day 0 after completion of the study procedure
measure: Subject Satisfaction Survey question for treatment subject's: Past IV starts have been difficult, uncomfortable or painful.
timeFrame: Day 0 after completion of the study procedure
measure: Subject Satisfaction Survey question for treatment subject's: Today, my IV was started easily.
timeFrame: Day 0 after completion of the study procedure
measure: Subject Satisfaction Survey question for treatment subject's: Pain associated with IV start procedure today.
timeFrame: Day 0 after completion of the study procedure
measure: Subject Satisfaction Survey question for treatment subject's: Pain associated with today's IV start compared to past IV starts.
timeFrame: Day 0 after completion of the study procedure
measure: Subject Satisfaction Survey question for treatment subject's: Anxiety associated with the IV start procedure today.
timeFrame: Day 0 after completion of the study procedure
measure: Subject Satisfaction Survey question for treatment subject's: Anxiety associated with today's IV start compared to past IV starts.
timeFrame: Day 0 after completion of the study procedure
measure: Subject Satisfaction Survey question for treatment subject's: Pain associated with the Veinplicity stimulation.
timeFrame: Day 0 after completion of the study procedure
measure: Subject Satisfaction Survey question for treatment subject's: Veinplicity improved the overall success of my experience.
timeFrame: Day 0 after completion of the study procedure
measure: Subject Satisfaction Survey question for treatment subject's: The Veinplicity device made it easier for the nurse to find a vein for my IV start today.
timeFrame: Day 0 after completion of the study procedure
measure: Subject Satisfaction Survey question for treatment subject's: I would choose the Veinplicity again for future IV starts.
timeFrame: Day 0 after completion of the study procedure
measure: Subject Satisfaction Survey question for treatment subject's: Overall, I was satisfied with today's IV start.
timeFrame: Day 0 after completion of the study procedure
measure: Clinician satisfaction
timeFrame: Assessed on Day 0 after completion of the study procedure
measure: Change in the vein quality score from baseline to pre-cannulation tourniquet application
timeFrame: Day 0
Locations:
city: Plymouth
country: United States
facility: Midwest Immunology Clinic and Infusion Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic-Rochester
state: Minnesota
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Gregory J Schears, MD
role: PRINCIPAL_INVESTIGATOR
References: