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

Not Applicable

Completed

• Conditions: Administration, Intravenous; Injections, Intravenous
• Interventions: Device: OptiVein Catheter; Device: Vasofix Certo Catheter

• Registration Number: NCT03145519
• Lead Sponsor: Optomeditech Oy

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.

Study Timeline

• Study Start: 2017-02-15
• Study First Submitted: 2017-02-20
• Study First Submitted QC: 2017-05-08
• Study First Posted: 2017-05-09
• Primary Completion: 2017-09-17
• Study Completion: 2017-09-17
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-11
• Last Update Posted: 2018-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OptiVein	OptiVein Catheter	Placement of IV-catheter and administration of treatment using OptiVein catheter.
Vasofix Certo	Vasofix Certo Catheter	Placement of IV-catheter and administration of treatment using Vasofix Certo catheter.

Primary Outcome Measures

Name	Time	Method
First attempt success rate	Immediate / During the procedure usually taking less than 1 minute	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.

Secondary Outcome Measures

Name	Time	Method
Number of attempts	Immediate / During the consecutive attempts to place the catheter, usually less than 30 minutes	Total number of attempts required for successful IV insertion.
Incidence of infection	72 hour follow-up or time of removal of catheter, whichever occurs first	Incidence of infection (phlebitis, dermatitis and induration) at insertion site through 72 hours or at the time of catheter removal, whichever occurs first.
Time to successful IV insertion	Immediate / During the procedure usually taking less than 1 minute if successful with first stick or within 30 minutes if further attempts are required	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
Incidence of blood extravasation resulting in a hematoma	Immediate / 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
Incidence of fluid extravasation delivered through catheter	Immediate / 72 hour follow-up or time of removal of catheter, whichever occurs first

Trial Locations

Locations (1)

Tartu University Hospital, Children's Clinic; 🇪🇪 Tartu, Estonia