A Trial to Demonstrate the Safety and Efficacy of the OptiVein IV Catheter In a Pediatric Population

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Controlled Trial to Demonstrate the Safety and Efficacy of the OptiVein IV Catheter In a Pediatric Population

Conditions
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Injections, Intravenous, Administration, Intravenous

Intervention / Treatment
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* Device: Vasofix Certo Catheter
* Device: OptiVein Catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OptiVein<br>Placement of IV-catheter and administration of treatment using OptiVein catheter. | Device: OptiVein Catheter<br>* Placement of IV-catheter<br>|
| Active Comparator: Vasofix Certo<br>Placement of IV-catheter and administration of treatment using Vasofix Certo catheter. | Device: Vasofix Certo Catheter<br>* Placement of IV-catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First attempt success rate | Successful IV insertion on the first attempt, defined as placement of the catheter inside the vein allowing for fluid or drug delivery or blood withdrawal. | Immediate / During the procedure usually taking less than 1 minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of attempts | Total number of attempts required for successful IV insertion. | Immediate / During the consecutive attempts to place the catheter, usually less than 30 minutes | 
| Time to successful IV insertion | Time to successful IV insertion, defined as time from the first skin puncture to placement of the catheter inside the vein allowing for fluid or drug delivery or blood withdrawal | Immediate / During the procedure usually taking less than 1 minute if successful with first stick or within 30 minutes if further attempts are required | 
| Incidence of blood extravasation resulting in a hematoma |  | Immediate / 72 hour follow-up or time of removal of catheter, whichever occurs first | 
| Incidence of fluid extravasation delivered through catheter |  | Immediate / 72 hour follow-up or time of removal of catheter, whichever occurs first | 
| Incidence of infection | Incidence of infection (phlebitis, dermatitis and induration) at insertion site through 72 hours or at the time of catheter removal, whichever occurs first. | 72 hour follow-up or time of removal of catheter, whichever occurs first | 
| Unplanned withdrawal of IV catheter |  | 72 hour follow-up or time of removal of catheter, whichever occurs first | 
| Overall complication rate composed from #2-5 above |  | 72 hour follow-up or time of removal of catheter, whichever occurs first |