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

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

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.

Study Overview

• Status: Completed
• Conditions: Injections, Intravenous; Administration, Intravenous
• Intervention / Treatment: Device: OptiVein Catheter; Device: Vasofix Certo Catheter

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 Type: Interventional
• Enrollment (Actual): 188
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Estonia
  • Tartu, Estonia, 51014
    • Tartu University Hospital, Children's Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Optomeditech Oy
• Collaborators: CardioMed Device Consultants, LLC
• Investigators: Principal Investigator: Tuuli Metsvaht, MD, Tartu University Hospital, Children's Clinic

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2017
• Primary Completion (Actual): September 17, 2017
• Study Completion (Actual): September 17, 2017

Study Registration Dates

• First Submitted: February 20, 2017
• First Submitted That Met QC Criteria: May 8, 2017
• First Posted (Actual): May 9, 2017

Study Record Updates

• Last Update Posted (Actual): September 13, 2018
• Last Update Submitted That Met QC Criteria: September 11, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: OMT-CT-004-PED

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No