Clinical trial NCT03145519: A Trial to Demonstrate the Safety and Efficacy of the OptiVein IV Catheter In a Pediatric Population
Official title: A Randomized Controlled Trial to Demonstrate the Safety and Efficacy of the OptiVein IV Catheter In a Pediatric Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injections, Intravenous
Administration, Intravenous
Lead sponsor: Optomeditech Oy
Sponsor class: INDUSTRY
Collaborators: name: CardioMed Device Consultants, LLC
First posted: 2017-05-09
Enrollment: 188
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective, single-center, open-label, randomized controlled trial to demonstrate the safety and efficacy of the OptiVein IV Catheter in the pediatric population. The study hypothesis is that OptiVein IV Catheter use will be superior to the control in successful venous access after first attempt.

Detailed description: The OptiVein IV Catheter is a sterile single use disposable intravascular cannulation device that is modified from CE certified Vasofix Certo Catheter from B.Braun with the additional features of an optical fiber and modified flashplug. The OptiVein System also includes an electronic unit.

The OptiVein Catheter shares a similar intended use and the same catheter components as the Vasofix Certo IV Catheter. Clinical data will be obtained to demonstrate that there is no change to the safety and efficacy profile due to the laser component of the OptiVein IV Catheter.

A prospective, single-center, open-label, randomized controlled trial to demonstrate the safety and efficacy of the OptiVein IV Catheter in the pediatric population. The study hypothesis is that OptiVein IV Catheter use will be superior to the control in successful venous access after first attempt.

Patients aged newborn to twelve (12) years requiring short-term use of an IV catheter to withdraw blood samples or to administer fluids or medications intravenously.

Participating sites will follow routine practice guidelines regarding the personnel responsible for inserting the catheters for this study, known herein as "operators." Operators must be professionally trained in IV catheter placement; educational background and level of experience of operator will be documented.

All Operators selected for participation in the study will undergo training on the protocol, Good Clinical Practice and the assembly and use of the OptiVein IV Catheter and Vasofix Certo IV catheter prior to enrolling patients into the study.

Randomization will be in a 1:1 fashion with assignment given by the electronic data capture (EDC) system.

Eligibility criteria: Inclusion Criteria:

* Aged newborn to 12 years
* Has written or verbal order for insertion of an IV
* Requires peripheral IV therapy (catheter)
* Has an insertion site in the forearm, hand, foot, leg, or head free of deformities, phlebitis, infiltration, dermatitis, burns, lesions or tattoos
* Demonstrates cooperation with a catheter insertion and the study protocol
* Informed consent has been obtained

Exclusion Criteria:

* Life expectancy less than 72h.
* Any child the research staff deem unobservable
* The study IV catheter site will be placed below an old infusion site
* Will likely require a power injection for a radiologic procedure during participation in this study

Primary outcomes:
measure: First attempt success rate
timeFrame: Immediate / During the procedure usually taking less than 1 minute
Secondary outcomes:
measure: Number of attempts
timeFrame: Immediate / During the consecutive attempts to place the catheter, usually less than 30 minutes
measure: Time to successful IV insertion
timeFrame: Immediate / During the procedure usually taking less than 1 minute if successful with first stick or within 30 minutes if further attempts are required
measure: Incidence of blood extravasation resulting in a hematoma
timeFrame: Immediate / 72 hour follow-up or time of removal of catheter, whichever occurs first
measure: Incidence of fluid extravasation delivered through catheter
timeFrame: Immediate / 72 hour follow-up or time of removal of catheter, whichever occurs first
measure: Incidence of infection
timeFrame: 72 hour follow-up or time of removal of catheter, whichever occurs first
measure: Unplanned withdrawal of IV catheter
timeFrame: 72 hour follow-up or time of removal of catheter, whichever occurs first
measure: Overall complication rate composed from #2-5 above
timeFrame: 72 hour follow-up or time of removal of catheter, whichever occurs first
Other outcomes:
Locations:
city: Tartu
country: Estonia
facility: Tartu University Hospital, Children's Clinic
Study officials:
affiliation: Tartu University Hospital, Children's Clinic
name: Tuuli Metsvaht, MD
role: PRINCIPAL_INVESTIGATOR
References: